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

Primary Purpose

Keloid, Surgical Scar

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

infra-red diode laser

About this trial

This is an interventional prevention trial for Keloid focused on measuring laser, keloid, scar

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

MagalonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

infra-red diode laser

Arm Description

one session, one dose

Outcomes

Primary Outcome Measures

treatment tolerability assessed by natures, intensity and incidences of the side effects, with a special oversight of skin burn lesion

Secondary Outcome Measures

improvement of scarring for plastic surgery group

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.

Lesion size Vancouver scar scale Observer scar scale (POSAS)

quality of life assessment for keloid group

VQ-dermato satisfaction questionnaire

Socio and medical economic evaluation for keloid group

Full Information

NCT ID

NCT01158196

First Posted

July 6, 2010

Last Updated

July 7, 2010

Sponsor

Ekkyo

1. Study Identification

Unique Protocol Identification Number

NCT01158196

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Unknown status

Study Start Date

June 2010 (undefined)

Primary Completion Date

April 2013 (Anticipated)

Study Completion Date

June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Ekkyo

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keloid, Surgical Scar

Keywords

laser, keloid, scar

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

infra-red diode laser

Arm Type

Experimental

Arm Description

one session, one dose

Intervention Type

Device

Intervention Name(s)

infra-red diode laser

Intervention Description

laser treatment of scar after keloid excision laser treatment of surgery scar

Primary Outcome Measure Information:

Title

treatment tolerability assessed by natures, intensity and incidences of the side effects, with a special oversight of skin burn lesion

Time Frame

10 days after surgery or excision

Secondary Outcome Measure Information:

Title

improvement of scarring for plastic surgery group

Description

Vancouver Scar Scale score Comparative scar assessment scale Observer assessment score (POSAS)

Time Frame

12 months after surgery

Title

keloid recurrence, an intralesional corticotherapy will be set up as soon as there is a recurrence.

Description

Lesion size Vancouver scar scale Observer scar scale (POSAS)

Time Frame

12 months after excision

Title

quality of life assessment for keloid group

Description

VQ-dermato satisfaction questionnaire

Time Frame

12 months after excision

Title

Socio and medical economic evaluation for keloid group

Time Frame

12 months after excision

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guy MAGALON, MD PhD

Phone

+33 (0)4 91 38 35 52

guy.magalon@ap-hm.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guy Magalon, MD PhD

Organizational Affiliation

plastic and reconstructive surgey department, APHM

Official's Role

Principal Investigator

Facility Information:

Facility Name

Magalon

City

Marseille

Country

France

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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