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

NCT ID: NCT01158196

Last Updated: 2010-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Keloid Surgical Scar

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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infra-red diode laser

one session, one dose

Group Type EXPERIMENTAL

infra-red diode laser

Intervention Type DEVICE

laser treatment of scar after keloid excision

laser treatment of surgery scar

Interventions

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infra-red diode laser

laser treatment of scar after keloid excision

laser treatment of surgery scar

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ekkyo

INDUSTRY

Sponsor Role lead

Responsible Party

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APHM

Principal Investigators

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Guy Magalon, MD PhD

Role: PRINCIPAL_INVESTIGATOR

plastic and reconstructive surgey department, APHM

Locations

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Magalon

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Guy MAGALON, MD PhD

Role: CONTACT

+33 (0)4 91 38 35 52

Other Identifiers

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2010-A00323-36

Identifier Type: OTHER

Identifier Source: secondary_id

E-200-M/keloid project

Identifier Type: -

Identifier Source: org_study_id

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