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

NCT00641420 | Completed

• 1 other identifier: HenryFord4447
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Scarring

Keywords

Acne scarring; Post inflammatory hyperpigmentation

Outcome Measures

Primary Outcomes (1)

• Improvement in acne scarring.

  Blinded evaluators will score improvement of acne via photographs using a quartile grading scale (0 = no improvement, 1 = minor improvement \[1-25%\], 2 =moderate improvement \[26-50%\], 3 =marked improvement \[51-75%\], 4 = very significant improvement \[76-100%\]).

  6 months

Secondary Outcomes (2)

• Dyspigmentation

  6 months

• Pain with treatment

  5 months

Study Arms (2)

Fractional Laser 10mJ

EXPERIMENTAL

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

Procedure: Fractionated Laser Resurfacing

Fractional Laser 40mJ

EXPERIMENTAL

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

Procedure: Fractionated Laser Resurfacing

Interventions

Fractionated Laser Resurfacing PROCEDURE

Also known as: Fractionated Laser: FRAXEL

Fractional Laser 10mJ; Fractional Laser 40mJ

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David M Ozog, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 24, 2008
• Study Start: September 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: September 1, 2008
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

US (1)