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

Phase 3

• Conditions: Surgical Scar; Keloid
• Interventions: Device: infra-red diode laser

• Registration Number: NCT01158196
• Lead Sponsor: Ekkyo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Status Verified: 2010-07
• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-07
• Last Update Submitted: 2010-07-07
• Study First Posted: 2010-07-08
• Last Update Posted: 2010-07-08
• Primary Completion: 2013-04
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
infra-red diode laser	infra-red diode laser	one session, one dose

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
improvement of scarring for plastic surgery group	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.	12 months after excision	* Lesion size; * Vancouver scar scale; * Observer scar scale (POSAS)
quality of life assessment for keloid group	12 months after excision	* VQ-dermato; * satisfaction questionnaire
Socio and medical economic evaluation for keloid group	12 months after excision

Trial Locations

Locations (1)

Magalon; 🇫🇷 Marseille, France