Pulsed Dye Laser and Affirm Laser in the Treatment of Abdominoplasty Scars

February 7, 2018 updated by: The Cleveland Clinic
The purpose of this study is to examine the effect of using a pulsed dye laser (the VBEAM), a non-ablative laser (the Affirm) and a combination of both lasers to improve the appearance of your surgical scar. Both the pulsed dye laser and Affirm laser are approved by the US Food and Drug Administration (FDA) for the treatment of scars. Surgical scars are a type of scar that can benefit from laser therapy. Redness and the appearance of small blood vessels near the surface of the skin (telangiectasias) develop in such scars as part of the normal healing process and usually spontaneously remit, but often slowly and incompletely. In many cases, lasers can accelerate the clearing of this redness and also improve scar texture.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In summary, we will perform a total of three laser treatments. A personal interview, clinical examination, and a photograph will be taken at each visit. At the end of the three treatments, a final personal interview, clinical evaluation and photograph will be taken to document the effects of the laser treatments. At the end of the study, the patient will have the option to receive two additional laser treatments four weeks apart, also at no cost, to the entire scar.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinical Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 18 years and older
  • No significant medical illness
  • Surgical procedure that involves closure of the transverse abdominal incision performed in the department of dermatology and plastic surgery at the Cleveland Clinic main campus.
  • Subjects with the willingness and ability to understand and provide informed consent

Exclusion Criteria:

  • Under 18 years of age
  • Pregnancy or Lactation
  • Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months
  • Subjects with liver/kidney disease, diabetes mellitus, hypertension, connective tissue disease or who are immunocompromised
  • Subjects with a known susceptibility to keloid formation or hypertrophic scarring
  • Subjects who are unable to understand the protocol or to give informed consent
  • Subjects with mental illness
  • Subjects with obvious non-healing wound

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pulsed dye laser
PDL Patient will be have scar treated with pulsed dye laser.
Device: pulsed dye laser
patient will have scar treated with pulsed dye laser
Other Names:
  • VBEAM
Active Comparator: Affirm laser
Patient will be have scar treated with Affirm Laser
Device: Affirm Laser
patient will have scar treated with Affirm laser
Other Names:
  • non-ablative laser
Active Comparator: combined PDL and Affirm Lasers
Patient will be have scar treated with combined Affirm + PDL
Device: combined PDL and Affirm Lasers
patient will have scar treated with Affirm and pulsed dye lasers
Other Names:
  • VBEAM, non-ablative laser
Placebo Comparator: Placebo
Patient will be have scar treated with Placebo
Other: Placebo
patient will receive no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of PDL vs Affirm Laser vs Combined Laser Treatments in Appearance of Surgical Scar
Time Frame: 1 year
The purpose of this study is to determine the efficacy of the 585-nm pulsed dye laser (PDL) and 1440-nm Affirm laser in the treatment of surgical scars starting one week after closure of transverse abdominal incision.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Study Director: Rebecca Tung, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

August 13, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Actual)

February 8, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 08-352

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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