NCT00685243

Brief Summary

  1. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

April 10, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

May 23, 2008

Last Update Submit

April 6, 2023

Conditions

Post Surgical Scars

Keywords

FraxelPulsed dye laserSurgical scars

Outcome Measures

Primary Outcomes (1)

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

    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).

    6 months

Study Arms (2)

Fraxel

ACTIVE COMPARATOR

Fraxel laser treatment

Procedure: Laser treatment

PDL

ACTIVE COMPARATOR

Pulsed dye laser treatment

Procedure: Laser treatment

Interventions

Laser treatmentPROCEDURE

Fraxel and pulsed dye laser

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Henry Ford Medical Center, 6530 Farmington Rd

West Bloomfield, Michigan, 48322, United States

Location

Related Publications (2)

  • 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.

    PMID: 8192370BACKGROUND

  • 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.

    PMID: 16581684BACKGROUND

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • David Kouba, MD, PhD

    Department of Dermatology, Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Dermatology

Study Record Dates

First Submitted

May 23, 2008

First Posted

May 28, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2008

Study Completion

July 1, 2008

Last Updated

April 10, 2023

Record last verified: 2023-04

Locations

US(1)