Clinical trial NCT00641420: Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin
Official title: Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Scarring
Keywords: Acne scarring
Post inflammatory hyperpigmentation
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2008-03-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Background: Ablative resurfacing lasers are effective for treatment of acne scars, but they have a high risk of complications. Fractional lasers have less severe side effects but more moderate efficacy than ablative devices. Studies were performed in individuals with Fitzpatrick skin type I to VI.

Objective: To determine the efficacy and safety of an erbium 1,550-nm fractional laser in the treatment of facial acne scars in Fitzpatrick skin types IV to VI.

Methods: We conducted a prospective, single-blind, randomized trial in patients with acne scars (n=15), skin type IV to VI, with a 1,550-nm erbium fractionated laser. Patients were divided into two groups; one was treated with 10 mJ and the other with 40 mJ. Five monthly laser sessions were performed. A patient questionnaire was distributed.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in acne scarring.
timeFrame: 6 months
Secondary outcomes:
measure: Dyspigmentation
timeFrame: 6 months
measure: Pain with treatment
timeFrame: 5 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: David M Ozog, MD
role: PRINCIPAL_INVESTIGATOR
References: