Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin

NCT ID: NCT00641420

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-09-30

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.

Conditions

Acne Scarring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fractional Laser 10mJ

Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 10mJ.

Group Type: EXPERIMENTAL

Fractionated Laser Resurfacing

Intervention Type: PROCEDURE

Fractional Laser 40mJ

Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 40mJ.

Group Type: EXPERIMENTAL

Fractionated Laser Resurfacing

Intervention Type: PROCEDURE

Interventions

Fractionated Laser Resurfacing

Intervention Type: PROCEDURE

Other Intervention Names

Fractionated Laser: FRAXEL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

David M. Ozog

Senior Staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David M Ozog, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

Henry Ford Health System

Detroit, Michigan, United States

Countries

United States

Other Identifiers

HenryFord4447

Identifier Type: -

Identifier Source: org_study_id