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

Not Applicable

Completed

• Conditions: Acne Scars

• Registration Number: NCT01221922
• Lead Sponsor: ConBio, a Cynosure Company

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-27
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Global Acne Scarring Classification	3 Months post final treatment

Secondary Outcome Measures

Name	Time	Method
Subject Satisfaction	3 Months post final treatment	5 point Likert scale

Trial Locations

Locations (1)

Kasemrad Aesthetic Center, Kasemrad Prachacheun Hospital; 🇹🇭 Bangkok, Thailand