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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 because the information has not been verified recently.
Verified July 2010 by Ekkyo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ekkyo
ClinicalTrials.gov Identifier:
NCT01158196
First received: July 6, 2010
Last updated: July 7, 2010
Last verified: July 2010
History of Changes
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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:

MedlinePlus related topics: Scars
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • improvement of scarring for plastic surgery group [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: Yes ]
    • Lesion size
    • Vancouver scar scale
    • Observer scar scale (POSAS)

  • quality of life assessment for keloid group [ Time Frame: 12 months after excision ] [ Designated as safety issue: No ]
    • VQ-dermato
    • satisfaction questionnaire

  • Socio and medical economic evaluation for keloid group [ Time Frame: 12 months after excision ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158196

Contacts
Contact: Guy MAGALON, MD PhD +33 (0)4 91 38 35 52 guy.magalon@ap-hm.fr

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

No publications provided

Responsible Party: Pr. Magalon/ Plastic Surgeon, APHM
ClinicalTrials.gov Identifier: NCT01158196     History of Changes
Other Study ID Numbers: E-200-M/keloid project, 2010-A00323-36
Study First Received: July 6, 2010
Last Updated: July 7, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Ekkyo:
laser
keloid
scar

Additional relevant MeSH terms:
Keloid
Recurrence
Cicatrix
Collagen Diseases
 Connective Tissue Diseases
Fibrosis
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on June 18, 2013