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
  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
Endpoint Classification: Safety/Efficacy Study
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:


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
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
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
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

No publications provided

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
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
Acne scarring
Post inflammatory hyperpigmentation

ClinicalTrials.gov processed this record on September 18, 2014