Laser Treatment of Moderate to Severe Acne Vulgaris

Study Overview
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Brief Summary
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In this study, we are enrolling subjects with moderate to severe acne vulgaris and investigating the use of a commercially available laser in treating acne.

Official Title
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Laser Treatment for the Clinical Improvement of Acne Vulgaris: A Self-Controlled Trial

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Device: Laser Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol; In good general health, based on answers provided during the screening visit; Subject must be able to read and understand English; Any gender and any Fitzpatrick skin type; Ages 18 through 40; Subjects must have moderate to severe nodular active facial acne vulgaris (PGA 3 or 4) Willing to sun protect treated area for the duration of enrollment in the study and 1 year after treatment; Subjects must be ineligible for or have declined standard of care treatments (e.g. oral isotretinoin therapy). Exclusion Criteria: Participation in another investigational drug or device clinical trial in the past 30 days; Currently undergoing or wish to begin or continue topical treatments; Are pregnant or lactating; History of allergic reaction to topical anesthesia; Subjects may not have undergone oral isotretinoin therapy within the past 12 months; Currently take oral antibiotic or oral therapy for acne; History of keloidal or hypertrophic scarring; Laser treatment in past six months; History of poor wound healing; Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Subjects in this arm will undergo laser treatment on their active acne vulgaris lesions. Subjects will serve as their own control. | Device: Laser Intervention<br>* Subjects with undergo laser exposure of their active acne vulgaris.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Physician's Global Assessment (PGA) of Acne Severity | The physician will score the acne vulgaris based on the Physician's Global Assessment (PGA) scale. A score of 0 indicates that residual hyperpigmentation and erythema may be present; a score of 1 indicates that there are a few scattered comedones and a few small papules; a score of 3 indicates that more than half of the face is involved, that there are many comedones, papules, and pustules, and that one nodule may be present; a score of 4 indicates that the entire face is involved, covered with comedones, numerous papules and pustules, and a few nodules and cysts. The change in PGA score will be recorded at each of the 4 study visits, for up to | Change in PGA score between baseline visit and post procedural visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne, Acne Vulgaris, Laser, Cystic Acne