Clinical trial NCT01221922: Laser Treatment of Acne Scars in Fitzpatrick Skin Types III-VI
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Scars
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Global Acne Scarring Classification
timeFrame: 3 Months post final treatment
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: 3 Months post final treatment
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Kasemrad Aesthetic Center, Kasemrad Prachacheun Hospital
Study officials:
affiliation: Kasemrad Aesthetic Center, Thailand
name: Niwat Polnikorn, MD
role: PRINCIPAL_INVESTIGATOR
References: