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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00641420
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : March 15, 2022
Sponsor:
Information provided by (Responsible Party):
David M. Ozog, 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

Detailed Description:

Background: Ablative resurfacing lasers are effective for treatment of acne scars, but they have a high risk of complications. Fractional lasers have less severe side effects but more moderate efficacy than ablative devices. Studies were performed in individuals with Fitzpatrick skin type I to VI.

Objective: To determine the efficacy and safety of an erbium 1,550-nm fractional laser in the treatment of facial acne scars in Fitzpatrick skin types IV to VI.

Methods: We conducted a prospective, single-blind, randomized trial in patients with acne scars (n=15), skin type IV to VI, with a 1,550-nm erbium fractionated laser. Patients were divided into two groups; one was treated with 10 mJ and the other with 40 mJ. Five monthly laser sessions were performed. A patient questionnaire was distributed.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel 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
Actual Primary Completion Date : August 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arms and Interventions
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Arm Intervention/treatment
Experimental: Fractional Laser 10mJ
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: Fractional Laser 40mJ
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 ]
    Blinded evaluators will score improvement of acne via photographs using a quartile grading scale (0 = no improvement, 1 = minor improvement [1-25%], 2 =moderate improvement [26-50%], 3 =marked improvement [51-75%], 4 = very significant improvement [76-100%]).


Secondary Outcome Measures :
  1. Dyspigmentation [ Time Frame: 6 months ]
    dyspigmentation will be assessed separately from acne scarring via photographs with blinded evaluators on a scale of 1- 3. 1 (minimal amount of hyperpigmentation), 2 (moderate hyperpigmentation) and 3 (severe amount of hyperpigmentation) depending on the degree of hyperpigmentation compared with their baseline photo.

  2. Pain with treatment [ Time Frame: 5 months ]
    subjects will report any pain with treatment on a 0-10 scale, with zero indicating no pain and 10 indicating the worst pain


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
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United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
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Principal Investigator: David M Ozog, MD Henry Ford Health System
More Information
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Responsible Party: David M. Ozog, Senior Staff, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00641420    
Other Study ID Numbers: HenryFord4447
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: March 2022
Keywords provided by David M. Ozog, Henry Ford Health System:
Acne scarring
Post inflammatory hyperpigmentation
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes