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 because the information has not been verified recently.

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

Tracking Information

First Received Date ^ICMJE

March 17, 2008

Last Updated Date

March 21, 2008

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00641420 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Acne Scarring

Intervention ^ICMJE

Procedure: Fractionated Laser Resurfacing

Other Name: Fractionated Laser: FRAXEL

Study Arm (s)

Experimental: 1
Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 10mJ.

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

Intervention: Procedure: Fractionated Laser Resurfacing

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

September 2008

Estimated Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 59 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00641420

Other Study ID Numbers ^ICMJE

HenryFord4447

Has Data Monitoring Committee

Responsible Party

David Ozog, MD/ Director Cosmetic Dermatology, Henry Ford Health System

Study Sponsor ^ICMJE

Henry Ford Health System

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

David M Ozog, MD

Henry Ford Health System

Information Provided By

Henry Ford Health System

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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