Safety and Efficacy of Infrared Diode Laser on Improvemen... | NCT01158196

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

NCT01158196

Sponsor

Ekkyo

Status

Unknown status

Last Update Posted

Jul 8, 2010Estimated

Enrollment

60Estimated

Phase

Phase 3

Conditions

Keloid
Surgical Scar

Interventions

infra-red diode laser

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010-A00323-36	Other Identifier	AFSSAPS - RCB ID NUMBER

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Apr 2013Estimated

Completion Date

Jun 2013Estimated

First Submitted Date

Jul 6, 2010

First Submission Date that Met QC Criteria

Jul 7, 2010

First Posted Date

Jul 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2010

Last Update Posted Date

Jul 8, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
infra-red diode laser	Experimental	one session, one dose	Device: infra-red diode laser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
infra-red diode laser	Device	laser treatment of scar after keloid excision laser treatment of surgery scar	infra-red diode laser

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
improvement of scarring for plastic surgery group	Vancouver Scar Scale score Comparative scar assessment scale Observer assessment score (POSAS)	12 months after surgery
keloid recurrence, an intralesional corticotherapy will be set up as soon as there is a recurrence.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guy MAGALON, MD PhD	Contact	+33 (0)4 91 38 35 52		guy.magalon@ap-hm.fr

Overall Officials

Name	Affiliation	Role
Guy Magalon, MD PhD	plastic and reconstructive surgey department, APHM	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Magalon	Recruiting	Marseille			France

Condition Browse Module

MeSH Terms

ID	Term
D007627	Keloid
D002921	Cicatrix

Ancestor Terms

ID	Term
D003095	Collagen Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D005355	Fibrosis

Browse Leaves

Not provided

Browse Branches

Not provided