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

Keloid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01158196
• Other study ID #: E-200-M/keloid project
• Secondary ID: 2010-A00323-36
• Status: Recruiting
• Phase: Phase 3
• First received: July 6, 2010
• Last updated: July 7, 2010
• Start date: June 2010
• Est. completion date: June 2013

Study information

• Verified date: July 2010
• Source: Ekkyo
• Contact: Guy MAGALON, MD PhD
• Phone: +33 (0)4 91 38 35 52
• Email: guy.magalon[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Keloid
• Surgical Scar

Intervention

Device:
• infra-red diode laser
laser treatment of scar after keloid excision laser treatment of surgery scar

Locations

Country	Name	City	State
France	Magalon	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Ekkyo

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment tolerability assessed by natures, intensity and incidences of the side effects, with a special oversight of skin burn lesion		10 days after surgery or excision	Yes
Secondary	improvement of scarring for plastic surgery group	Vancouver Scar Scale score; Comparative scar assessment scale; Observer assessment score (POSAS)	12 months after surgery	No
Secondary	keloid recurrence, an intralesional corticotherapy will be set up as soon as there is a recurrence.	Lesion size; Vancouver scar scale; Observer scar scale (POSAS)	12 months after excision	Yes
Secondary	quality of life assessment for keloid group	VQ-dermato; satisfaction questionnaire	12 months after excision	No
Secondary	Socio and medical economic evaluation for keloid group		12 months after excision	No