Acne Scars
Conditions
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).
Interventions
DEVICERevLite Q-Switched Nd:YAG Laser
Laser treatment once every 2 weeks for a total of 10 treatments.
Sponsors
ConBio, a Cynosure Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Acne Scarring Classification | 3 Months post final treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | 3 Months post final treatment | 5 point Likert scale |
Countries
Thailand
Outcome results
None listed