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CompletedNCT00685243Updated Apr 10, 2023

Treatment of Surgical Scars With Fractional Photothemolysis Versus Pulse Dye Laser

An interventional study of Laser treatment in Post Surgical Scars, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-10.

Sponsored by Henry Ford Health System · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2008, registered May 2008).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

  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.
Read the detailed description

RATIONALE FOR THE PROJECT

Surgical scars are a challenging condition to treat. The aesthetic outcome of surgical scars is of great importance to patients and physicians after reconstructive surgery. The current approaches for the treatment of surgical scars range from non-invasive approaches to aggressive treatments with re-excision or ablative resurfacing lasers. Fractional photothemolysis is a new technology whereby only microthermal zones of injury to the skin are created which triggers the wound healing response, leading to skin repair mechanisms to improve the appearance and textural changes associated with surgical scars.

Fractional photothemolysis (Fraxel SR laser, Reliant technologies, Inc) is a new technology whereby only microthermal zones of injury to the skin are created which triggers the wound healing response, leading to skin repair mechanisms to improve the appearance and textural changes associated with surgical scars. Fractionated resurfacing, with its significant proven efficacy in improving textural and pigmenatary abnormalities with a benign side effect profile, represents a promising novel treatment for surgical scars.

Aim:

Comparison of the outcome of the half of the surgical scar treated with Fraxel SR (Reliant Technologies, Inc.) laser versus the outcome of the contralateral half of the surgical scar which will be treated with the V-Beam Pulse Dye Laser

SIGNIFICANCE:

The cosmetic outcome of surgical scars is of paramount importance to surgeons and patients treated with both cosmetic and reconstructive surgery. It is impossible for surgeons to predict the wound healing properties of individual patients and particular anatomic sites and thus, there is little certainty that can be offered to patients about the cosmetic outcome of their surgical scars.

SUBJECTS IN THE PROJECT:

Inclusion Criteria:

For inclusion, the subject must:

  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:

A. 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.

B. The control for this study will be the side of the scar treated with the V-Beam Pulse Dye Laser

C. 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.

PROJECT DESIGN AND PROCOTOL:

  1. A comparison trial of surgical scars treated with Fraxel SR Laser (Reliant Technologies, Inc.) versus V-Beam Pulse Dye Laser (Candela Corporation) in 15 patients who underwent Mohs surgery and resultant cosmetic surgical reconstruction at Henry Ford Health System Department of Dermatology.
  2. At a minimum of 2 months post surgical reconstruction, patients will be eligible for inclusion in this research study. During each 2 weeks of the study, one side of the surgical scar will be treated with Fraxel SR (Reliant Technologies, Inc.) and the other half will be treated with the V-Beam Pulse Dye Laser (Candela Corporation) for aesthetic improvement of the scar
02

Conditions studied

  • Post Surgical Scars

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Keywords

  • Fraxel
  • Pulsed dye laser
  • Surgical scars
03

In context

Cicatrix

307 studies on the registry are indexed under Cicatrix; 50 are open to participants now.

This study's enrollment of 12 is below the median of 39 across 251 interventional studies indexed under Cicatrix.

Browse Cicatrix studies →

Lead sponsor

Henry Ford Health System is the lead sponsor of 293 studies on the registry; 50 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    Fraxel

    Fraxel laser treatment

    Procedure: Laser treatment

  • Active comparator
    PDL

    Pulsed dye laser treatment

    Procedure: Laser treatment

Interventions

  • ProcedureLaser treatment

    Fraxel and pulsed dye laser

    Also known as: -Fraxel SR Laser (Reliant Technologies, Inc.), -V-Beam Pulse Dye laser (Candela Corporation)

06

What researchers measure

Primary outcomes

  1. Overall cosmetic appearance, relative to adjacent skin and side effects.

    Time frame: 6 months

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Department of Dermatology, Henry Ford Medical Center, 6530 Farmington Rd
    West Bloomfield, Michigan 48322, United States
08

References and documents

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. doi: 10.1097/00000637-199402000-00015. PubMed 8192370 ↗
  • 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. doi: 10.1080/14764170600607251. PubMed 16581684 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00685243
Lead sponsor
Henry Ford Health System
Collaborators
American Academy of Cosmetic Surgery
Responsible party
David M. Ozog (Chair, Department of Dermatology, Henry Ford Health System) — Principal investigator
First posted
May 28, 2008
Start date
Jan 2008
Primary completion
Jun 2008
Completion
Jul 2008
Last update
Apr 10, 2023

Study contacts

David Kouba, MD, PhD
principal investigator · Department of Dermatology, Henry Ford Health System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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