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

Ekkyo

Status and phase: Unknown; Phase 3

Conditions: Keloid; Surgical Scar

Treatments: Device: infra-red diode laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT01158196

E-200-M/keloid project

2010-A00323-36 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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60 participants in 1 patient group

infra-red diode laser

Experimental group

Description:

one session, one dose

Treatment:

Device: infra-red diode laser