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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified March 2008 by Henry Ford Health System.
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by:

Henry Ford Health System

ClinicalTrials.gov Identifier:

NCT00641420

First received: March 17, 2008

Last updated: March 21, 2008

Last verified: March 2008

History of Changes

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:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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 ]

Secondary Outcome Measures:

Dyspigmentation [ Time Frame: 6 months ]
Pain with treatment [ Time Frame: 5 months ]


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

Eligibility


Ages Eligible for Study:	18 Years to 59 Years (Adult)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	David Ozog, MD/ Director Cosmetic Dermatology, Henry Ford Health System
ClinicalTrials.gov Identifier:	NCT00641420 History of Changes
Other Study ID Numbers:	HenryFord4447
Study First Received:	March 17, 2008
Last Updated:	March 21, 2008

Keywords provided by Henry Ford Health System:


Acne scarring Post inflammatory hyperpigmentation

Additional relevant MeSH terms:


Cicatrix Fibrosis Pathologic Processes

ClinicalTrials.gov processed this record on June 23, 2017

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