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

• Sponsor: Ekkyo (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01158196
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Duration (Months): 36
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated 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: Jun 1, 2010
• Anticipated Primary Completion Date: Apr 1, 2013
• Anticipated Study Completion Date: Jun 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. improvement of scarring for plastic surgery group [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. [12 months after excision]

   Lesion size Vancouver scar scale Observer scar scale (POSAS)

3. quality of life assessment for keloid group [12 months after excision]

   VQ-dermato satisfaction questionnaire

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Magalon	Marseille		France

Sponsors and Collaborators

• Ekkyo

Investigators

• Principal Investigator: Guy Magalon, MD PhD, plastic and reconstructive surgey department, APHM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01158196
• Other Study ID Numbers: E-200-M/keloid project; 2010-A00323-36
• First Posted: Jul 8, 2010
• Last Update Posted: Jul 8, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: laser; keloid; scar
• Additional relevant MeSH terms: Keloid; Recurrence

Study Results

No Results Posted as of Jul 8, 2010