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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01158196
Recruitment Status : Unknown
Verified July 2010 by Ekkyo.
Recruitment status was:  Recruiting
First Posted : July 8, 2010
Last Update Posted : July 8, 2010
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Keloid Surgical Scar Device: infra-red diode laser Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Infra-red Diode Laser on Improvement of Surgical Scar and on the Prevention of Excised Keloids Recurrence-Pilot Study
Study Start Date : June 2010
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. quality of life assessment for keloid group [ Time Frame: 12 months after excision ]
    • VQ-dermato
    • satisfaction questionnaire

  4. Socio and medical economic evaluation for keloid group [ Time Frame: 12 months after excision ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01158196

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Contact: Guy MAGALON, MD PhD +33 (0)4 91 38 35 52

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Magalon Recruiting
Marseille, France
Sponsors and Collaborators
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Principal Investigator: Guy Magalon, MD PhD plastic and reconstructive surgey department, APHM
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Responsible Party: Pr. Magalon/ Plastic Surgeon, APHM Identifier: NCT01158196    
Other Study ID Numbers: E-200-M/keloid project
2010-A00323-36 ( Other Identifier: AFSSAPS - RCB ID NUMBER )
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: July 8, 2010
Last Verified: July 2010
Keywords provided by Ekkyo:
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes
Collagen Diseases
Connective Tissue Diseases