Safety and Efficacy of Infrared Diode Laser on Improvement of Scar and Prevention of Recurrence of Excised Keloid

July 7, 2010 updated by: Ekkyo

Effect of Infra-red Diode Laser on Improvement of Surgical Scar and on the Prevention of Excised Keloids Recurrence-Pilot Study

A pilot study will be conducted on 2 type of subjects, one with plastic surgery scar with a randomization of laser treated portions, and other with keloid excision scar with a complete laser treatment. The aim is to evaluate the infra-red diode laser influence on keloid recurrence and scar prevention. The keloid recurrence rate will be evaluated at each visit, and the scar prevention in plastic surgery will be evaluated comparing laser treated portion and non-treated portion.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Marseille, France
        • Recruiting
        • Magalon

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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years and older
  • Skin type from I to VI (Fitzpatrick classification scale)
  • Scar longer than 4cm for plastic surgery's patients OR scar longer than 2cm for keloid patients

Exclusion Criteria:

  • Malignant tumor pathology
  • Infectious or viral skin disease
  • Immunosuppressive pathology and/or immunosuppressive treatment,
  • Long-term corticosteroid treatment
  • Pregnant woman

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: infra-red diode laser
one session, one dose
Device: infra-red diode laser

laser treatment of scar after keloid excision

laser treatment of surgery scar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
treatment tolerability assessed by natures, intensity and incidences of the side effects, with a special oversight of skin burn lesion
Time Frame: 10 days after surgery or excision
10 days after surgery or excision

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement of scarring for plastic surgery group
Time Frame: 12 months after surgery
  • Vancouver Scar Scale score
  • Comparative scar assessment scale
  • Observer assessment score (POSAS)
12 months after surgery
keloid recurrence, an intralesional corticotherapy will be set up as soon as there is a recurrence.
Time Frame: 12 months after excision
  • Lesion size
  • Vancouver scar scale
  • Observer scar scale (POSAS)
12 months after excision
quality of life assessment for keloid group
Time Frame: 12 months after excision
  • VQ-dermato
  • satisfaction questionnaire
12 months after excision
Socio and medical economic evaluation for keloid group
Time Frame: 12 months after excision
12 months after excision

Collaborators and Investigators

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

Sponsor

Ekkyo

Investigators

  • Principal Investigator: Guy Magalon, MD PhD, plastic and reconstructive surgey department, APHM

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

June 1, 2010

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

July 6, 2010

First Submitted That Met QC Criteria

July 7, 2010

First Posted (Estimate)

July 8, 2010

Study Record Updates

Last Update Posted (Estimate)

July 8, 2010

Last Update Submitted That Met QC Criteria

July 7, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-200-M/keloid project
  • 2010-A00323-36 (Other Identifier: AFSSAPS - RCB ID NUMBER)

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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