Clinical studies

Blue light phototherapy clinical studies

A Randomised Controlled Study for theTreatment of Acne Vulgaris using HighIntensity 414nm Solid State Diode Arrays
J Cosmet Laser Ther. 2015;17(4):170-6. doi: 10.3109/14764172.2015.1007064. Epub 2015 Feb 20.
Ash C, Harrison A, Drew S, Whittall R.

The treatment of acne vulgaris poses a challenge to the dermatologist, and the disease causes emotional anxiety for the patient. The treatment of acne vulgaris may be well-suited to home-use applications, where sufferers may be too embarrassed to seek medical treatment. This randomized controlled study is designed to quantify the effectiveness of using a blue light device in a therapy combined with proprietary creams, in the investigation of a self-treatment regimen. A total of 41 adults with mild-to-moderate facial inflammatory acne were recruited. The subjects were randomly assigned to combination blue light therapy (n = 26) or control (n = 15). Photography was used for qualitative assessment of lesion counts, at weeks 1, 2, 4, 8, and 12. All subjects in the treatment cohort achieved a reduction in their inflammatory lesion counts after 12 weeks. The mean inflammatory lesion counts reduced by 50.02% in the treatment cohort, and increased by 2.45% in the control cohort. The reduction in inflammatory lesions was typically observable at week-3, and maximal between weeks 8 and 12. The treatment is free of pain and side-effects. The blue light device offers a valuable alternative to antibiotics and potentially irritating topical treatments. Blue light phototherapy, using a narrow-band LED light source, appears to be a safe and effective additional therapy for mild to moderate acne.

Acne phototherapy with a high-intensity, enhanced, narrow-band, blue light source: an open study and in vitro investigation.
J Dermatol Sci. 2002 Nov;30(2):129-35.
Kawada A, Aragane Y, Kameyama H, Sangen Y, Tezuka T.

The purpose of this study was to investigate the efficacy of phototherapy with a newly-developed high-intensity, enhanced, narrow-band, blue light source in patients with mild to moderate acne. An open study was performed in acne patients who were treated twice a week up to 5 weeks. Acne lesions were reduced by 64%. Two patients experienced dryness. No patient discontinued treatment due to adverse effects. In vitro investigation revealed that irradiation from this light source reduced the number of Propionibacterium acnes (P. acnes), but not Staphylococcus epidermidis that were isolated from the acne patients. Phototherapy using this blue light source was effective and well tolerated in acne patients and had an ability to decrease numbers of P. acnes in vitro, suggesting that this phototherapy may be a new modality for the treatment of acne.

The effective treatment of acne vulgaris by a high-intensity, narrow band 405-420 nm light source.
J Cosmet Laser Ther. 2003 Jun;5(2):111-7.
Elman M, Slatkine M, Harth Y.

Available topical treatments are slow and frequently irritating. Oral therapies may be associated with increased bacterial resistance (antibiotics) or possible severe side effects (oral isotretinoin). In vitro and in vivo exposure of acne bacteria to 405-420 nm ultraviolet (UV) free blue light results in the photo-destruction of these bacteria through the effects on the porphyrins produced naturally by Propionibacterium acnes. A novel, high-intensity, narrow band 420 nm UV free blue light has been shown to decrease inflammatory acne lesions after eight bi-weekly treatments. OBJECTIVES: To examine the effects of high-intensity, narrow band 420 nm UV free blue light (ClearLight) on inflammatory acne lesions. METHODS: Three studies were carried out to examine the clinical effects of high-intensity, narrow band blue light on papulo-pustular acne: the split-face dose-response study, the full-face open trial and the split-face, double-blind controlled study. The studies enrolled 10, 13 and 23 patients respectively. RESULTS: The data show more than an 80% response to 420 nm acne phototherapy with a significant reduction of 59-67% of inflammatory acne lesions after only eight treatments of 8-15 minutes. The reduction in lesions was steady in the follow-ups at 2, 4 and 8 weeks after the end of therapy. Prolonged remission was evident in the 8 weeks after the end of therapy. No adverse effects or patient discomfort were noted in any of the patients. CONCLUSIONS: Acne phototherapy by high intensity, narrow band 405-420 nm light is proven to be an attractive, fast, effective, non-invasive alternative to current topical and parenteral anti-acne remedies.

 

SAFETY AND EFFECTIVENESS OF A NEW BLUE LIGHT DEVICE FOR THE SELF-TREATMENT OF MILD-TO-MODERATE ACNE.
J Clin Aesthet Dermatol 2012 May;5(5):25-31
Ronald G Wheeland, Andrea Koreck
Objective: To assess the safety and effectiveness of treating acne for eight weeks using a new blue light device at a dose of ˜2J/cm2/day (representing typical full-face treatment) or ˜29J/cm2/day (representing the typical dose after localized spot treatment of acne). Design: Prospective, single-center, open-label study evaluating two levels of blue light in each subject. Setting: Subjects were recruited from the local community for self-treatment at home. Thirty-two subjects with mild or moderate facial acne vulgaris. Measurements: Inflammatory lesion count; number, severity, and redness of flares; improvement in skin characteristics (overall appearance, clarity, radiance, tone, texture, and smoothness); tolerability; subject satisfaction. Results: The blue light treatment was associated with significant reductions from baseline in inflammatory lesion count as early as Week 1 with ˜29J/cm2/day and Week 3 with ˜2J/cm2/day (P≤ 0.01). It was also associated with significant reductions in the number, severity, and redness of flares and with improvements in the skin’s appearance, clarity, radiance, tone, texture, and smoothness. Overall, 53 percent of subjects considered the treatment much gentler than traditional acne treatments and 61 percent were satisfied. Three adverse events were probably related to treatment—minimal transient skin dryness (2) and minimal transient hyperpigmentation (1). Conclusion: The blue light treatment is effective and well tolerated, offering rapid, gentle, and convenient treatment of inflammatory acne. The blue light device offers a valuable alternative to antibiotics and potentially irritating topical treatments and can also be used adjunctively to complement other therapies.

EVALUATION OF SELF-TREATMENT OF MILD-TO-MODERATE FACIAL ACNE WITH A BLUE LIGHT TREATMENT SYSTEM.

J Drugs Dermatol 2011 Jun;10(6):596-602

Ronald G Wheeland, Sunil Dhawan

This study evaluated the efficacy and tolerability of treating mild-to-moderate facial acne using a new, hand-held, light-emitting diode blue light device in conjunction with a foam cleanser containing 5% glycolic acid and 2% salicylic acid plus a skin rebuilding serum containing 1.25% salicylic acid, 0.5% niacinamide, 0.08% liposomal-based azelaic acid and superoxide dismutase. Volunteers with mild-to-moderate facial inflammatory acne used the blue light device twice daily for eight weeks, plus the cleanser before treatments and the serum after each evening treatment. Among 33 subjects aged 25-45 years old, 28 completed. In a 3 cm x 5 cm target area receiving a daily dose of ~29 J/cm2, treatment was associated with significant reductions from baseline in the inflammatory lesion count from week 1 onward (P≤ .01) and in the non-inflammatory lesion count from week 4 onward (P≤ .05). The number of flares was significantly reduced from baseline from week 2 onward (P≤ .05), and flare severity and flare redness were significantly reduced from baseline from week 4 onward (P≤ .01 and P≤ .05, respectively). At week 8, more than 90 percent of subjects reported improvements in their skin's overall appearance, clarity, radiance, tone, texture and smoothness. In addition, 82 percent were satisfied, very satisfied, or extremely satisfied with the blue light treatment system and 86 percent agreed the treatment system was much gentler than traditional acne treatments. The blue light treatment system offers effective, rapid, convenient and well tolerated treatment of inflammatory and non-inflammatory acne lesions. The majority of subjects consider it much gentler than traditional acne treatments and it facilitates effective treatment without the need for antibiotic exposure. The blue light treatment system and blue light therapy alone are attractive treatment options for acne vulgaris, both as alternatives to traditional acne treatments and as adjunctive treatments to complement existing therapies.

AN OPEN STUDY TO DETERMINE THE EFFICACY OF BLUE LIGHT IN THE TREATMENT OF MILD TO MODERATE ACNE.
J Dermatolog Treat 2005 ;16(4):219-23
C A Morton, R D Scholefield, C Whitehurst, J Birch
The effective management of acne remains a challenge; achieving an optimal response whilst minimizing adverse events is often difficult. The rise in antibiotic resistance threatens to reduce the future usefulness of the current mainstay of therapy. The need for alternative therapies remains important. Phototherapy has previously been shown to be effective in acne, with renewed interest as both endogenous and exogenous photodynamic therapies are demonstrated for this condition. Objectives: To determine the effect of narrowband blue light in the reduction of inflammatory and non-inflammatory lesions in patients with mild to moderate acne and to evaluate patient tolerance of the therapy. We performed an open study utilizing a blue LED light source in 30 subjects with mild to moderate facial acne. Two weeks after screening, lesions were counted and recorded by lesion type. Over 4 weeks, patients received eight 10- or 20-minute light treatments, peak wavelength 409-419 nm at 40 mW/cm2. Assessments were taken at weeks 5, 8 and 12 and lesion counts were recorded. Repeated measures-ANOVA and Dunnett's tests, respectively, allowed assessment of the different scores over time and permitted comparison of mean counts. RESULTS: An overall effect on inflammatory counts was observed at week 5, and a statistically significant decrease in inflamed counts was detected at the week 8 assessments, which continued to week 12. There was little effect on non-inflamed lesions. The treatment was well tolerated with adverse events experienced generally rated as being mild and usually self-limiting. CONCLUSIONS: Eight 10- or 20-minute treatments over 4 weeks with a narrowband blue light was found to be effective in reducing the number of inflamed lesions in subjects with mild to moderate acne. The treatment had little effect on the number of comedones. The onset of the effect was observable at the first assessment, at week 5, and maximal between weeks 8 and 12. Blue light phototherapy using a narrowband LED light source appears to be a safe and effective additional therapy for mild to moderate acne.

Light-emitting diode 415 nm in the treatment of inflammatory acne: an open-label, multicentric, pilot investigation.
J Cosmet Laser Ther. 2006 Apr;8(1):31-3.
Tremblay JF1, Sire DJ, Lowe NJ, Moy RL.
The management of acne remains a challenge, with current therapies linked to significant side effects and patient non-compliance. Phototherapy using blue light has been proven in the treatment of acne vulgaris and offers the clinician an effective alternative.
OBJECTIVE: To determine the effect of narrowband light-emitting diode (LED) blue light in the reduction of inflammatory and non-inflammatory lesions in patients with mild to moderate acne and to evaluate patient tolerance of the therapy. METHODS: Forty-five patients were treated with high-intensity pure blue light, 415 nm and 48 J/cm2, receiving two treatments of 20 minutes per week for a period of 4-8 weeks. Clinical assessment was performed at baseline, and 2, 4 and 8 weeks after treatment. A patient's therapeutic response was measured using a global improvement scoring system. RESULTS: The mean improvement score was 3.14 at 4 weeks and 2.90 at 8 weeks. Nine patients experienced complete clearing at 8 weeks. The treatment was well tolerated, with 50% of patients highly satisfied with the treatment. CONCLUSION: This open-label study suggests the therapeutic efficacy of high-intensity LED pure blue light in the treatment of acne vulgaris with no reported side effects.

Phototherapy with blue and red light clinical studies

Phototherapy with blue (415 nm) and red (660 nm) light in the treatment of acne vulgaris.
Br J Dermatol. 2000 May;142(5):973-8.
Papageorgiou P, Katsambas A, Chu A.

In this study we have evaluated the use of blue light (peak at 415 nm) and a mixed blue and red light (peaks at 415 and 660 nm) in the treatment of acne vulgaris. One hundred and seven patients with mild to moderate acne vulgaris were randomized into four treatment groups: blue light, mixed blue and red light, cool white light and 5% benzoyl peroxide cream. Subjects in the phototherapy groups used portable light sources and irradiation was carried out daily for 15 min. Comparative assessment between the three light sources was made in an observer-blinded fashion, but this could not be achieved for the use of benzoyl peroxide. Assessments were performed every 4 weeks. After 12 weeks of active treatment a mean improvement of 76% (95% confidence interval 66-87) in inflammatory lesions was achieved by the combined blue-red light phototherapy; this was significantly superior to that achieved by blue light (at weeks 4 and 8 but not week 12), benzoyl peroxide (at weeks 8 and 12) or white light (at each assessment). The final mean improvement in comedones by using blue-red light was 58% (95% confidence interval 45-71), again better than that achieved by the other active treatments used, although the differences did not reach significant levels. We have found that phototherapy with mixed blue-red light, probably by combining antibacterial and anti-inflammatory action, is an effective means of treating acne vulgaris of mild to moderate severity, with no significant short-term adverse effects.

Blue and red light combination LED phototherapy for acne vulgaris in patients with skin phototype IV.
Lasers Surg Med. 2007 Feb;39(2):180-8.
Lee SY1, You CE, Park MY.

Blue light is effective for acne treatment, inducing photodynamic destruction of Propionibacterium acnes (P. acnes). This study was designed to investigate the efficacy of combined blue and red light-emitting diode (LED) phototherapy for acne vulgaris. Twenty-four patients with mild to moderately severe facial acne were treated with quasimonochromatic LED devices, alternating blue (415 nm) and red (633 nm) light. The treatment was performed twice a week for 4 weeks. Objective assays of the skin condition were carried out before and after treatment at each treatment session. Clinical assessments were conducted before treatment, after the 2nd, 4th, and 6th treatment sessions and at 2, 4, and 8 weeks after the final treatment by grading and lesion counting. The final mean percentage improvements in non-inflammatory and inflammatory lesions were 34.28% and 77.93%, respectively. Instrumental measurements indicated that the melanin levels significantly decreased after treatment. Brightened skin tone and improved skin texture were spontaneously reported by 14 patients. Blue and red light combination LED phototherapy is an effective, safe and non-painful treatment for mild to moderately severe acne vulgaris, particularly for papulopustular acne lesions.

COMBINATION BLUE (415 NM) AND RED (633 NM) LED PHOTOTHERAPY IN THE TREATMENT OF MILD TO SEVERE ACNE VULGARIS.
J Cosmet Laser Ther 2006 Jun;8(2):71-5
David J Goldberg, Bruce A Russell

Acne vulgaris represents both a challenge to the treating dermatologist and a major concern for the patient. Conventional treatments have proved inconsistent with often unacceptable side effects and high rates of recurrence. Non-thermal, non-laser, phototherapy for acne with a combination of blue and red light has recently attracted attention. The present study was designed to assess the efficacy of this combination phototherapy. Twenty-four subjects, Fitzpatrick skin types II-V, with mild to severe symmetric facial acne vulgaris were recruited for the study. Subjects were well matched at baseline in terms of both age and duration of acne. Subjects were treated over eight sessions, two per week 3 days apart, alternating between 415 nm blue light (20 minutes/session, 48 J/cm2) and 633 nm red light (20 minutes/session, 96 J/cm2) from a light-emitting diode (LED)-based therapy system. Patients received a mild microdermabrasion before each session. Acne was assessed at baseline and at weeks 2, 4, 8 and 12. RESULTS: Twenty-two patients completed the trial. A mean reduction in lesion count was observed at all follow-up points. At the 4-week follow-up, the mean lesion count reduction was significant at 46% (p=0.001). At the 12-week follow-up, the mean lesion count reduction was also significant at 81% (p=0.001). Patient and dermatologist assessments were similar. Severe acne showed a marginally better response than mild acne. Side effects were minimal and transitory. Comedones did not respond as well as inflammatory lesions. CONCLUSIONS: Combination blue and red LED therapy appears to have excellent potential in the treatment of mild to severe acne. Treatment appears to be both pain- and side effect-free.

THE CLINICAL AND HISTOLOGICAL EFFECT OF HOME-USE, COMBINATION BLUE-RED LED PHOTOTHERAPY FOR MILD-TO-MODERATE ACNE VULGARIS IN KOREAN PATIENTS: A DOUBLE-BLIND, RANDOMIZED CONTROLLED TRIAL.
Br J Dermatol 2013 May;168(5):1088-94
H H Kwon, J B Lee, J Y Yoon, S Y Park, H H Ryu, B M Park, Y J Kim, D H Suh

Blue and red light have been reported to have beneficial effects on acne. However, there has been no double-blind, randomized study of acne treatment for combined blue and red light-emitting diode (LED) devices, and the associated molecular mechanisms have rarely been investigated. OBJECTIVES: To evaluate the efficacy, safety and histological changes of combined blue and red LED phototherapy for acne vulgaris. METHODS: Thirty-five patients with mild-to-moderate acne were randomly assigned to either a home-use irradiation group using an LED device, or a control group using a sham device. The treatment group was instructed to serially irradiate their forehead and cheeks with 420-nm blue light and 660-nm red light for 2.5 min twice daily for 4 weeks. RESULTS: At the final visit at 12 weeks, both inflammatory and noninflammatory acne lesions had decreased significantly, by 77% and 54%, respectively, in the treatment group. No significant difference was observed in the control group. In the treatment group, sebum output reduction, attenuated inflammatory cell infiltrations and a decreased size of the sebaceous gland were found. The immunostaining intensities for interleukin (IL)-8, IL-1α, matrix metalloproteinase-9, toll-like receptor-2, nuclear factor-κB, insulin-like growth factor-1 receptor and sterol response element binding protein (SREBP)-1 were reduced concomitantly. Messenger RNA expression of SREBP-1c was also decreased. No severe adverse reactions were reported. CONCLUSIONS: This LED phototherapy was safe and effective for treating not only inflammatory but also noninflammatory acne lesions, with good compliance. The experimental results correlated well with clinical results, partly elucidating the related molecular mechanisms.

Handheld LED array device in the treatment of acne vulgaris.
J Drugs Dermatol. 2008 Apr;7(4):347-50.
Sadick NS.
The successful treatment of acne still remains problematic. Conventional therapies often prove inconsistent with unacceptable side effects and recurrence rates, leading to patient noncompliance. A thermal phototherapy treatment using a combination of blue light and red light has recently attracted much attention and seems to offer an effective alternative. The objective of this study was to evaluate the efficacy of blue light (415 nm) in combination with red light (633 nm) in the reduction of inflammatory lesions on the face of subjects (n=21) with mild to moderate acne vulgaris after a course of 8 20-minute (blue) or 30-minute (red) alternated light treatments, self-administered by a handheld unit over a period of 4 weeks. Lesion counts progressively reduced throughout the 4-week light therapy period and continued to reduce up to 8 weeks posttherapy, with a final average reduction of 69% seen 8 weeks after the treatment course (P>.001). This pattern is similar to previously reported studies.

 

A study to determine the effect of combination blue (415 nm) and near-infrared (830 nm) light-emitting diode (LED) therapy for moderate acne vulgaris.
J Cosmet Laser Ther. 2009 Jun;11(2):125-8. doi: 10.1080/14764170902777349.
Sadick N.

Acne vulgaris remains a major problem in dermatological practice. Phototherapy for acne with blue (415 nm) and red (633 nm) light-emitting diode (LED) arrays has recently attracted attention. This pilot study assessed the efficacy of the combination of 415 nm and near-infrared (IR) LED therapy for moderate acne. METHODS: Seventeen individuals were recruited: 13 females and four males. Skin types ranged from type II to type VI, and the acne grades at baseline ranged from Burton grade 1 to 5. Patients underwent twice-weekly 20-minute sessions of LED therapy for 4 weeks, alternating between the blue (415 nm) and near-IR (830 nm) heads. No other treatment was allowed. Results were assessed and compared with the baseline values at 1, 4 and 8 weeks post-treatment. RESULTS: Six individuals failed to complete the study. Eleven individuals showed improvement ranging from 0% to 83.3%. A downward shift in the Burton grade was seen overall. Non-inflammatory lesion counts increased in four patients, but improved in the other seven by an average of 48.8%. No adverse effects were reported. CONCLUSIONS: The combination therapy for acne produced results which were less effective in the reduction of inflammatory lesions than those achieved with the previously reported blue/red combination. Further study with a much larger patient population is warranted.

Use of salicylic acid in the treatment of acne clinical studies

Treatment of acne vulgaris with salicylic acid pads.
Clin Ther. 1992 Mar-Apr;14(2):247-53.
Zander E, Weisman S.

Most cases of acne vulgaris are either mild or moderate in severity and well-suited for treatment with nonprescription agents that are safe, effective, and convenient to use. A review of four clinical studies and a comedolytic assay attests to the efficacy and safety of 0.5% and 2% solutions of salicylic acid for the treatment of acne vulgaris. In three placebo-controlled studies and a comedolytic assay, salicylic acid pads reduced the number of primary lesions and thereby the number and severity of all lesions associated with acne. Comparative studies of salicylic acid have shown it to be superior to benzoyl peroxide in reducing the total number of acne lesions. Adverse reactions to salicylic acid are generally limited to mild, local irritation occurring in a minority of patients.

Comparison of a salicylic acid cleanser and a benzoyl peroxide wash in the treatment of acne vulgaris.
Clin Ther. 1989 Mar-Apr;11(2):264-7.
Shalita AR.

A four-week crossover study to compare the efficacy of an acne cleanser containing 2% salicylic acid with that of a 10% benzoyl peroxide wash was conducted in 30 patients with acne vulgaris. The results demonstrated that only patients treated with the salicylic acid cleanser had a significant reduction in comedones. Patients treated with the salicylic acid cleanser for the first two weeks showed a significant improvement in acne, but worsened during benzoyl peroxide therapy over the following two weeks. In contrast, patients initially treated with the benzoyl peroxide wash for the first two weeks continued to improve with salicylic acid cleanser over the next two weeks.

Jessner's solution vs. 30% salicylic acid peels: a comparative study of the efficacy and safety in mild-to-moderate acne vulgaris.
J Cosmet Dermatol. 2016 Aug 25. doi: 10.1111/jocd.12266.
Dayal S, Amrani A, Sahu P1, Jain VK1.

Chemical peeling is a well-identified therapeutic modality for acne vulgaris (AV). Jessner's solution (JS) is a known peeling agent for acne since more than 100 years. Salicylic acid (SA) peel is a well-established peeling agent for acne. There is paucity of literature comparing the current peeling agents of choice, that is, SA with the older peeling agents, that is, JS for acne. OBJECTIVE: To compare the efficacy and safety of 30% SA vs. JS peels in treatment of mild-to-moderate facial acne in Indian patients. METHOD: A total of 40 patients with mild-to-moderate AV were enrolled for 12 weeks and were randomly divided into two groups: group 1, 30% SA peels and group 2, JS peels were performed 2 weeks apart with total of six peels in 12-week duration. Clinical improvement was assessed objectively using Michaelsson acne scores (MAS) and clinical photographs. Side effects were observed at each visit. RESULTS: At the end of therapy, improvement in MAS and percentage decrease in MAS were significantly higher in group 1 as compared to group 2. Likewise, decrease in mean comedone counts in group 1 was significantly higher as compared to group 2. However, there was no statistically significant difference in the decrease in mean papule and pustule counts between the two groups. Both the groups tolerated the peels well. CONCLUSION: Thus, 30% SA peels were more effective than JS peels in treatment of noninflammatory lesions, that is, comedones and in overall improvement of mild-to-moderate facial acne vulgaris.

Salicylic acid peels for the treatment of acne vulgaris in Asian patients.
Dermatol Surg. 2003 Dec;29(12):1196-9; discussion 1199.
Lee HS, Kim IH.
Salicylic acid peels have been introduced as a useful modality in acne treatment. Few studies have examined its efficacy and safety, especially in darker skin. OBJECTIVE: To assess the efficacy and safety of salicylic acid peels as a treatment for acne vulgaris in Asian patients. METHODS: Thirty-five Korean patients with facial acne were treated with 30% salicylic acid peels biweekly for 12 weeks. Lesion counts and Dr. Cunliffe's score were assessed by a blinded evaluator. Safety assessments and patient's evaluations were also recorded. RESULTS: Both inflammatory and noninflammatory acne lesion counts were decreased in proportion to the duration of treatment. Dr. Cunliffe's acne grade was statistically significantly decreased after treatment. The side effects were tolerable in most cases, and all patients were pleased with their peel results. Stratum corneum hydration, skin surface lipid, skin pH, and transepidermal water loss were unchanged from baseline levels. CONCLUSION: Salicylic acid peels are an effective and safe therapy for acne vulgaris in Asian patients.

Comparison of alpha- and beta-hydroxy acid chemical peels in the treatment of mild to moderately severe facial acne vulgaris.
Dermatol Surg. 2008 Jan;34(1):45-50; discussion 51. Epub 2007 Dec 5.
Kessler E, Flanagan K, Chia C, Rogers C, Glaser DA.
Chemical peels are used as adjuvants for treatment of facial acne. No well-controlled studies have compared alpha- and beta-hydroxy acid peels in the treatment of mild to moderately severe facial acne. OBJECTIVE: To compare the efficacy of alpha- and beta-hydroxy acid chemical peels in the treatment of mild to moderately severe facial acne vulgaris. Twenty patients were recruited in this split-face, double-blind, randomized, controlled study. An alpha-hydroxy acid (30% glycolic acid) was applied to one-half of the face and a beta-hydroxy acid peel (30% salicylic acid) was applied contralaterally every 2 weeks for a total of six treatments. A blinded evaluator performed quantitative assessment of papules and pustules. RESULTS: Both chemical peels were significantly effective by the second treatment (p<.05) and there were no significant differences in effectiveness between the two peels. At 2 months posttreatment, the salicylic acid peel had sustained effectiveness. More adverse events were reported with the glycolic acid peel after the initial treatment. CONCLUSION: The glycolic acid and salicylic acid peels were similarly effective. The salicylic acid peel had sustained effectiveness and fewer side effects. Alpha- and beta-hydroxy acid peels both offer successful adjunctive treatment of facial acne vulgaris.

Dietary clinical trials relating to Acne Vulgaris

Effect of Dietary Supplementation with Omega-3 Fatty Acid and Gamma-linolenic Acid on Acne Vulgaris: A Randomised, Double-blind, Controlled Trial
Jae Yoon Jung, Hyuck Hoon Kwon, Jong Soo Hong, Ji Young Yoon, Mi Sun Park, Mi Young Jang, Dae Hun Suh
DOI: 10.2340/00015555-1802 
This study was undertaken to evaluate the clinical efficacy, safety, and histological changes induced by dietary omega-3 fatty acid and γ-linoleic acid in acne vulgaris. A 10-week, randomised, controlled parallel dietary intervention study was performed in 45 participants with mild to moderate acne, which were allocated to either an omega-3 fatty acid group (2,000 mg of eicosapentaenoic acid and docosahexaenoic acid), a γ-linoleic acid group (borage oil containing 400 mg γ-linoleic acid), or a control group. After 10 weeks of omega-3 fatty acid or γ-linoleic acid supplementation, inflammatory and non-inflammatory acne lesions decreased significantly. Patient subjective assessment of improvement showed a similar result. Heamatoxylin & eosin staining of acne lesions demonstrated reductions in inflammation and immunohistochemical staining intensity for interleukin-8. No severe adverse effect was reported. This study shows for the first time that omega-3 fatty acid and γ-linoleic acid could be used as adjuvant treatments for acne patients.

Multicenter Randomized Comparative Double-Blind Controlled Clinical Trial of the Safety and Efficacy of Zinc Gluconate versus Minocycline Hydrochloride in the Treatment of Inflammatory Acne vulgaris
Dermatology 2001;203:135-140
Dreno et al.
In addition to tetracyclines, zinc may constitute an alternative treatment in inflammatory lesions of acne. Objective: To evaluate the place of zinc gluconate in relation to antibiotics in the treatment of acne vulgaris. Methods: Zinc was compared to minocycline in a multicenter randomized double-blind trial. 332 patients received either 30 mg elemental zinc or 100 mg minocycline over 3 months. The primary endpoint was defined as the percentage of the clinical success rate on day 90 (i.e. more than 2/3 decrease in inflammatory lesions, i.e. papules and pustules). Results: This clinical success rate was 31.2% for zinc and 63.4% for minocycline. Minocycline nevertheless showed a 9% superiority in action at 1 month and one of 17% at 3 months, with respect to the mean change in lesion count. Regarding safety, the majority of the adverse effects of zinc gluconate and of minocycline concerned the gastrointestinal system and weremoderate (5 dropouts with zinc gluconate and 4 with minocycline). Conclusion: Minocycline and zinc gluconate are both effective in the treatment of inflammatory acne, but minocycline has a superior effect evaluated to be 17% in our study.

Evaluation of serum vitamins A and E and zinc levels according to the severity of acne vulgaris
Cutaneous and Ocular Toxicology Volume 33, 2014 - Issue 2. Pinar Ozuguz et al.
Although hyperseborrhea, follicular hyperkeratinization, Propionibacterium acnes colonization and inflammation are found to be responsible in the pathogenesis of acne, the exact mechanisms are unknown. Vitamin A and E are basic antioxidants vital for health. Zinc is also an essential element for human. But these parameters of the effects on skin are not fully understood. We aimed to evaluate plasma levels of vitamin A, E and zinc in acne patients in relation to the severity of the disease. Material and method: There were 94 acne patients who were referred to our clinic, all new diagnosed, and 56 age and sex matched healthy volunteers as control group. All patients are assessed according to Global Acne Grading System and grouped as mild, moderate, severe and very severe. Acne patients further grouped as group 1 consist of patients with mild to moderate disease; and group 2 consist of patients with severe to very severe acne. The patients with the controls and group 1 with group 2 was compared. Results: The level of vitamin E, vitamin A and zinc were significantly lower than the control group (Table 1,p < 0.001). When the patient group is compared among each other there was no statistically significant difference for plasma vitamin A levels between group 1 and 2 whereas vitamin E and zinc levels were significantly low in group 2 than group 1. Thus there was a negative correlation between acne severity and vitamin E and zinc levels. Conclusion: Our study marks the importance of diet in patients with acne. We offer supportive dietary measures with foods rich in vitamin A and E and zinc in the acne prophylaxis and treatment. Supportive treatment with these vitamins and zinc in severe acne may lead to satisfactory results.

Oral green tea catechin metabolites are incorporated into human skin and protect against UV radiation-induced cutaneous inflammation in association with reduced production of pro-inflammatory eicosanoid 12-hydroxyeicosatetraenoic acid.
British Journal of Nutrition Volume 110, Issue 5 September 2013, pp. 891-900
Rhodes et al. 

Green tea catechins (GTC) reduce UV radiation (UVR)-induced inflammation in experimental models, but human studies are scarce and their cutaneous bioavailability and mechanism of photoprotection are unknown. We aimed to examine oral GTC cutaneous uptake, ability to protect human skin against erythema induced by a UVR dose range and impact on potent cyclo-oxygenase- and lipoxygenase-produced mediators of UVR inflammation, PGE2 and 12-hydroxyeicosatetraenoic acid (12-HETE), respectively. In an open oral intervention study, sixteen healthy human subjects (phototype I/II) were given low-dose GTC (540 mg) with vitamin C (50 mg) daily for 12 weeks. Pre- and post-supplementation, the buttock skin was exposed to UVR and the resultant erythema quantified. Skin blister fluid and biopsies were taken from the unexposed and the UVR-exposed skin 24 h after a pro-inflammatory UVR challenge (three minimal erythema doses). Urine, skin tissue and fluid were analysed for catechin content and skin fluid for PGE2 and 12-HETE by liquid chromatography coupled to tandem MS. A total of fourteen completing subjects were supplement compliant (twelve female, median 42·5 years, range 29–59 years). Benzoic acid levels were increased in skin fluid post-supplementation (P= 0·03), and methylated gallic acid and several intact catechins and hydroxyphenyl-valerolactones were detected in the skin tissue and fluid. AUC analysis for UVR erythema revealed reduced response post-GTC (P= 0·037). Pre-supplementation, PGE2 and 12-HETE were UVR induced (P= 0·003, 0·0001). After GTC, UVR-induced 12-HETE reduced from mean 64 (sd 42) to 41 (sd 32) pg/μl (P= 0·01), while PGE2 was unaltered. Thus, GTC intake results in the incorporation of catechin metabolites into human skin associated with abrogated UVR-induced 12-HETE; this may contribute to protection against sunburn inflammation and potentially longer-term UVR-mediated damage.

Dietary effect of lactoferrin-enriched fermented milk on skin surface lipid and clinical improvement of acne vulgaris.
Nutrition. 2010 Sep;26(9):902-9. doi: 10.1016/j.nut.2010.05.011.
Kim J1, Ko Y, Park YK, Kim NI, Ha WK, Cho Y.
Lactoferrin, a whey milk protein after removing precipitated casein, has a prominent activity against inflammation in vitro and systemic effects on various inflammatory diseases have been suggested. The objective was to determine dietary effects of lactoferrin-enriched fermented milk on patients with acne vulgaris, an inflammatory skin condition. METHODS: Patients 18 to 30 y of age were randomly assigned to ingest fermented milk with 200 mg of lactoferrin daily (n = 18, lactoferrin group) or fermented milk only (n = 18, placebo group) in a 12-wk, double-blind, placebo-controlled study. Acne lesion counts and grade were assessed at monthly visits. The condition of the skin by hydration, sebum and pH, and skin surface lipids was assessed at baseline and 12 wk. RESULTS: Acne showed improvement in the lactoferrin group by significant decreases in inflammatory lesion count by 38.6%, total lesion count by 23.1%, and acne grade by 20.3% compared with the placebo group at 12 wk. Furthermore, sebum content in the lactoferrin group was decreased by 31.1% compared with the placebo group. The amount of total skin surface lipids decreased in both groups. However, of the major lipids, amounts of triacylglycerols and free fatty acids decreased in the lactoferrin group, whereas the amount of free fatty acids decreased only in the placebo group. The decreased amount of triacylglycerols in the lactoferrin group was significantly correlated with decreases in serum content, acne lesion counts, and acne grade. No alterations in skin hydration or pH were noted in either group. CONCLUSION: Lactoferrin-enriched fermented milk ameliorates acne vulgaris with a selective decrease of triacylglycerols in skin surface lipids.

The effect of probiotics on immune regulation, acne, and photoaging
International Journal of Women's Dermatology
Volume 1, Issue 2, June 2015, Pages 85–89
Through basic science and animal and human clinical trials, the evidence is growing for the use of probiotics in the treatment of acne. Acne formation is dependent upon several processes, including follicular hyperkeratinization, excess sebum production, Propiobacterium acnes colonization, and an inflammatory cascade ( Baquerizo Nole et al., 2014). Successful acne outcomes are influenced by compliance with topical regimens that can commonly cause skin barrier disruption, leading to dryness and irritation. Consequently, calming inflammation as well as maintaining skin hydration and barrier repair are of primary importance when treating acne. Probiotics modify several factors in the pathophysiology of acne development and can potentially improve compliance as well.

 
 
 
 

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