2940nm Er:YAG Laser Versus Benzoyl Peroxide Gel for the Treatment of Inflammatory Acne

Study Overview
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Brief Summary
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Acne is one of the most common conditions that patients seek for help in dermatological clinic. Nowadays, conventional treatment including topical agents(retinoids, antibiotics ,antiseptics and keratolytic agents) and systemic agents( antibiotics and retinoids) give a satisfying result but not to every patient. Some patients are not well respond to conventional therapy while some patients are unable to tolerate side effects of the treatments. Therefore, interventions to reduce acne are vigorously experimented . Lights and lasers including intense pulsed light, pulsed dye laser with or without photosensitizer and infrared lasers have been found to be useful in treating active inflammatory acne. Although,pain ,downtime and poor response of comedonal acne are limitations of those lights and lasers therapy. 2940 nm Erbium:YAG laser which has both resurfacing and photothermal effects is our laser of interest to seek for its efficacy in the treatment of inflammatory acne.

Official Title
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A Randomized Split-Face Controlled Trial Comparing Efficacy of 2940 Nanometer Er:YAG Laser to 2.5% BP Gel for the Treatment of Inflammatory Acne

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Device: 2940 nm Er:YAG laser (DualisXS M002-2A, Fotona®, Fotona d.d, Ljubljana, Slovenia)
* Drug: Benzoyl Peroxide gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 year-old to 45 year-old Mild to moderate severity of acne vulgaris with at least 5 active inflammatory acne lesions on each side of the face and less than 25% difference in lesion count between each side of face Fitzpatrick skin phototype I-IV Exclusion Criteria: History or clinical presentation of hypertrophic scar or keloid Photoaggravated skin diseases i.e. systemic lupus erythematosus, polymorphous light eruption, solar urticaria Oral isotretinoin taken within the last 6 months prior to enrollment Topical retinoid within 4 weeks prior to enrollment Systemic acne therapies (oral antibiotics) within 4 week prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Er:YAG laser<br> | Device: 2940 nm Er:YAG laser (DualisXS M002-2A, Fotona®, Fotona d.d, Ljubljana, Slovenia)<br>* 2 passes of 2940nm Er:YAG laser<br>* Other names: DualisXS M002-2A, Fotona®, Fotona d.d, Ljubljana, Slovenia;|
| Active Comparator: BP gel<br> | Drug: Benzoyl Peroxide gel<br>* 2.5% benzoyl peroxide gel apply twice daily on inflammatory acne on the control side of face<br>* Other names: 2.5% benzoyl peroxide gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage change from baseline of inflammatory acne lesion count at 6 week after 1st 2940nm Er:YAG laser treatment | % change from baseline = (NV- NB)/NB x 100% NV = number of lesion at each visit NB = number of lesion at baseline | 6 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Safety profile of 2940nm Er:YAG laser for the treatment of inflammatory acne including; Visual analogue scale of pain score Adverse events(AEs) include types of AEs(erythema, pain/burning sensation, dryness/excessive scaling, pigmentary change), timing, intenstity, outcome and action taking regarding to study procedure particular subject. | week0,2,4 | 
| Photographic clinical improvement | Photographic clinical improvement of acne, acne scar, erythema, hyperpigmentation and overall improvement by blinded dermatologists using quartile grading system comparing baseline and each clinical visit (week 2,4,6 and 10) | week 2,4,6 and 10 | 
| Patient satisfaction | Self evaluation of patient satisfaction | week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne vulgaris