Observational Study of Keloids Scars Treated by Shaving a... | NCT02886091

Studies
Observational Study of Keloids Scars Treated by Shaving and Cryosurgery

NCT02886091

Sponsor

University Hospital, Brest

Status

Unknown status

Last Update Posted

May 9, 2019Actual

Enrollment

25Estimated

Phase

Not provided

Conditions

Keloids Scars

Interventions

Not provided

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

Status Module

Record Verification Date

May 2019

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

Aug 2014

Primary Completion Date

Aug 2019Estimated

Completion Date

Aug 2019Estimated

First Submitted Date

Aug 29, 2016

First Submission Date that Met QC Criteria

Aug 31, 2016

First Posted Date

Sep 1, 2016Estimated

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

May 7, 2019

Last Update Posted Date

May 9, 2019Actual

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

Treatment of keloids scars is difficult and controversial. These keloids have a functional and aesthetic impact. A lot of treatment are described with a lot of relapses and aggravation. Authors report outcomes of the treatment with shaving and cryosurgery

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
size scar	reduction size scar	Inclusion and one years after

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

keloids scars
treatment of shaving and cryosurgery

Exclusion Criteria:

immunosuppressive therapy
chemotherapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Keloids scars

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alexandra Trimaille	Contact			alexandra.trimaille@chu-brest.fr

Overall Officials

Name	Affiliation	Role
Alexandra Trimaille	CHRU de Brest	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest	Recruiting	Brest		29609	France

Condition Browse Module

MeSH Terms

ID	Term
D007627	Keloid
D017439	Cicatrix, Hypertrophic

Ancestor Terms

ID	Term
D003095	Collagen Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D002921	Cicatrix

Browse Leaves

Not provided

Browse Branches

Not provided