Laser Treatment of Acne Scars in Fitzpatrick Skin Types III-VI

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the RevLite Q-Switched Neodymium: Yttrium-Aluminum-Garnet (Nd:YAG) Laser in the treatment of acne scars in darker skin types (Fitzpatrick Skin Types III, IV, V and VI).

Official Title
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A Study of the RevLite Q-Switched Neodymium: Yttrium-Aluminum-Garnet (Nd:YAG) Laser for the Treatment of Acne Scars in Fitzpatrick Skin Types III-VI

Conditions
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Acne Scars

Intervention / Treatment
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* Device: RevLite Q-Switched Nd:YAG Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older with Fitzpatrick Skin Type III, IV, V or VI Evidence of atrophic scarring Exclusion Criteria: Pregnancy, lactating or planning to become pregnant during the study History of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis Any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy Any condition which, in the investigator's opinion, would make it unsafe for the subject to participate Currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days prior to entering the study Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function Subject may be unreliable for the study. This includes subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits Use of oral or topical isotretinoin therapy within 6 months prior to enrollment. With the exception of isotretinoin, subjects will be allowed to continue their topical or oral acne medications during the trial Need to be exposed to artificial tanning devices or excessive sunlight during the trial Prior treatment with parenteral gold therapy Diabetes Type I or II, Lupus, Scleroderma or a similar immune system disorder Subject does not agree to refrain from any other type of facial skin resurfacing (e.g., microdermabrasion, laser or IPL treatment, chemical peel) or injected filler/other substances (e.g., Restylane, Botox) that might affect the treatment area for the duration of the study Underlying silicone or other nonabsorbable fillers in the treatment area or has had filler (e.g., collagen, fat) injections within the past 3 months History of keloidal scarring or nodulocystic acne Phenol or chemical peel or dermabrasion to the the treatment area within the past 6 months

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acne treatment<br>Treatment of acne scars | Device: RevLite Q-Switched Nd:YAG Laser<br>* Laser treatment once every 2 weeks for a total of 10 treatments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Acne Scarring Classification |  | 3 Months post final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Satisfaction | 5 point Likert scale | 3 Months post final treatment |