Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin
This trial is active, not recruiting.
|Treatment||fractionated laser resurfacing|
|Sponsor||Henry Ford Health System|
|Start date||September 2007|
|End date||August 2008|
|Trial size||15 participants|
|Trial identifier||NCT00641420, HenryFord4447|
Fractionated laser resurfacing is commonly used as a treatment for acne scarring in fair skinned individuals. This study aims to test the efficacy and safety in darker skin types. Patients are randomized to either the 10mJ 40mJ dosages and receive a total of five treatments at 17% one month apart. Improvement is judged by a dermatologist as 0-25%, 25-50%, 50-75% or 75-100%. Side effects such as pigmentary abnormalities and pain are also evaluated.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Improvement in acne scarring.
time frame: 6 months
time frame: 6 months
Pain with treatment
time frame: 5 months
Male or female participants from 18 years up to 59 years old.
Inclusion Criteria: - Male or female voluntary patients between the ages of 18 and 59 with Fitzpatrick skin type IV-VI as verified by one of the investigators - Patients with clinical diagnosis of ice pick, rolling, or boxcar type ane scarring - Patients able to follow instructions - If patient has a history of cold sores (herpes labialis) they must be willing to take prophylactic valtrex - Written informed consent from the patients (Appendix II) Exclusion Criteria: - Children (less than 18 years old) - Pregnant or lactating women - Personal history of keloids or hypertrophic scarring - Active acne requiring topical or oral therapy - Accutane or other oral retinoid in past year - Patients with a known allergy to lidocaine - Allergy to valacyclovir in a patient that needs prophylaxis - Patients with an unstable or non controlled underlying medical problem - Patients who are not able to follow instructions - Patients who have participated in a study within the 3 months prior to study entry - Patients who refuse to give written informed consent - Patients with a history of a pigmentary abnormality
|Official title||Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin|
|Principal investigator||David M Ozog, MD|
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