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

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ClinicalTrials.gov Identifier: NCT00641420
Recruitment Status : Unknown
Verified March 2008 by Henry Ford Health System.
Recruitment status was:  Active, not recruiting
First Posted : March 24, 2008
Last Update Posted : March 24, 2008
Sponsor:
Information provided by:
Henry Ford Health System

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acne Scarring Procedure: Fractionated Laser Resurfacing Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin
Study Start Date : September 2007
Estimated Primary Completion Date : August 2008
Estimated Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in acne scarring. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Dyspigmentation [ Time Frame: 6 months ]
  2. Pain with treatment [ Time Frame: 5 months ]

Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: March 24, 2008
Last Verified: March 2008

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

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes