This trial is active, not recruiting.

Condition acne scarring
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 10mJ.
fractionated laser resurfacing Fractionated Laser: FRAXEL
Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 40mJ.
fractionated laser resurfacing Fractionated Laser: FRAXEL

Primary Outcomes

Improvement in acne scarring.
time frame: 6 months

Secondary Outcomes

time frame: 6 months
Pain with treatment
time frame: 5 months

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2008.
Information provided to ClinicalTrials.gov by Henry Ford Health System.