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

Sponsored by:	Henry Ford Health System
Information provided by:	Henry Ford Health System
ClinicalTrials.gov Identifier:	NCT00641420

Purpose

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.

Condition	Intervention
Acne Scarring	Procedure: Fractionated Laser Resurfacing

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin

Resource links provided by NLM:

MedlinePlus related topics: Acne Scars

U.S. FDA Resources

Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:

Improvement in acne scarring. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Dyspigmentation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Pain with treatment [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment:	15
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 10mJ.	Procedure: Fractionated Laser Resurfacing
2: Experimental Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 40mJ.	Procedure: Fractionated Laser Resurfacing

Eligibility

Ages Eligible for Study:	18 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641420

Locations

United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202

Sponsors and Collaborators

Henry Ford Health System

Investigators

Principal Investigator:

David M Ozog, MD

Henry Ford Health System

More Information

No publications provided

Responsible Party:	Henry Ford Health System ( David Ozog, MD/ Director Cosmetic Dermatology )
Study ID Numbers:	HenryFord4447
Study First Received:	March 17, 2008
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00641420 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Henry Ford Health System:

Acne scarring
Post inflammatory hyperpigmentation

Study placed in the following topic categories:

Exanthema
Hyperpigmentation
Facial Dermatoses
Facies

Skin Diseases
Sebaceous Gland Diseases
Acne Vulgaris
Cicatrix

Additional relevant MeSH terms:

Facial Dermatoses
Skin Diseases
Acneiform Eruptions

Sebaceous Gland Diseases
Acne Vulgaris
Cicatrix

ClinicalTrials.gov processed this record on September 10, 2009