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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Ekkyo.
Recruitment status was:  Recruiting
Information provided by:
Ekkyo Identifier:
First received: July 6, 2010
Last updated: July 7, 2010
Last verified: July 2010
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 Intervention Phase
Keloid Surgical Scar Device: infra-red diode laser Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Ekkyo:

Primary Outcome Measures:
  • 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:
  • 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)

  • 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)

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

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

Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01158196

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

Magalon Recruiting
Marseille, France
Sponsors and Collaborators
Principal Investigator: Guy Magalon, MD PhD plastic and reconstructive surgey department, APHM
  More Information

Responsible Party: Pr. Magalon/ Plastic Surgeon, APHM Identifier: NCT01158196     History of Changes
Other Study ID Numbers: E-200-M/keloid project
2010-A00323-36 ( Other Identifier: AFSSAPS - RCB ID NUMBER )
Study First Received: July 6, 2010
Last Updated: July 7, 2010

Keywords provided by Ekkyo:

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Collagen Diseases
Connective Tissue Diseases
Fibrosis processed this record on September 21, 2017