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Treatment of Surgical Scars With Fractional Photothemolysis Versus Pulse Dye Laser
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Henry Ford Health System
American Academy of Cosmetic Surgery
Information provided by: Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00685243
  Purpose
  1. Evaluate the efficacy of the Fraxel SR laser to improve the cosmetic appearance of surgical scars, both in terms of pigmentary and textural changes.
  2. Evaluate the efficacy of the V-Beam Pulse Dye laser, a standard non-ablative laser which is utilized for the treatment of the erythematous and telangiectasia component of surgical scars.
  3. Comparison of the outcome of the half of the surgical scar treated with Fraxel SR laser versus the outcome of the contralateral half of the surgical scar which will be treated with the V-Beam Pulse Dye Laser.

Condition Intervention
Post Surgical Scars
 Procedure: Laser treatment

MedlinePlus related topics: Cosmetics Scars Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: Treatment of Surgical Scars With Fractional Photothemolysis Versus Pulse Dye Laser

Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Overall cosmetic appearance, relative to adjacent skin and side effects. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • skin matches surrounding skin, no scar formation visible, skin pigmentation and/or texture of scarred region is markedly different from surrounding skin). [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: January 2008
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fraxel: Active Comparator
Fraxel laser treatment
Procedure: Laser treatment
Fraxel and pulsed dye laser
PDL: Active Comparator
Pulsed dye laser treatment
Procedure: Laser treatment
Fraxel and pulsed dye laser

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be at least 18 years old;
  2. Be otherwise healthy;
  3. Be treated by Dr. Kouba for a skin cancer surgery or plastic surgery procedure
  4. Agree to attend up 6 sessions post Mohs surgery (2-4 laser treatment sessions and 2 follow-up visits post-laser)
  5. Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form;
  6. Agree to follow and undergo all study-related procedures.

Exclusion Criteria:

  1. Patients who do not meet the criteria above and/or who fail to follow their post-operative instructions or make both of their post-operative clinic appointments.
  2. The control for this study will be the side of the scar treated with the V-Beam Pulse Dye Laser
  3. We will be speaking to patients at Henry Ford Dermatology regarding participation in our study. We will ensure that all patients understand the voluntary nature of their participation in the study. They will sign informed consent. In addition, we will be asking patients to give us their assessment of which side of their surgical wound had better improvement, the side treated with Fraxel laser versus the side treated with V-Beam Pulse Dye Laser.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685243

Locations
United States, Michigan
Department of Dermatology, Henry Ford Medical Center, 6530 Farmington Rd
West Bloomfield, Michigan, United States, 48322
Sponsors and Collaborators
Henry Ford Health System
American Academy of Cosmetic Surgery
Investigators
Principal Investigator: David Kouba, MD, PhD Department of Dermatology, Henry Ford Health System
  More Information

Publications:
Alster TS. Improvement of erythematous and hypertrophic scars by the 585-nm flashlamp-pumped pulsed dye laser. Ann Plast Surg. 1994 Feb;32(2):186-90.
Behroozan DS, Goldberg LH, Dai T, Geronemus RG, Friedman PM. Fractional photothermolysis for the treatment of surgical scars: a case report. J Cosmet Laser Ther. 2006 Apr;8(1):35-8.

Responsible Party: Department of Dermatology, Henry Ford Health Sys ( David Kouba, MD, PhD )
Study ID Numbers: IRB4812
Study First Received: May 23, 2008
Last Updated: May 27, 2008
ClinicalTrials.gov Identifier: NCT00685243  
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
Fraxel
Pulsed dye laser
Surgical scars

Study placed in the following topic categories:
Skin Diseases
Cicatrix

ClinicalTrials.gov processed this record on February 11, 2009



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