Keloid Scarring: Treatment and Pathophysiology | NCT01295099

Studies
Keloid Scarring: Treatment and Pathophysiology

NCT01295099

Sponsor

Queen Mary University of London

Status

Withdrawn

Last Update Posted

Sep 18, 2023Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Keloid Scar

Interventions

5- fluorouracil
radiotherapy
Triamcinolone

Countries

United Kingdom

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

Oct 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 11, 2011

First Submission Date that Met QC Criteria

Feb 11, 2011

First Posted Date

Feb 14, 2011Estimated

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

Sep 14, 2023

Last Update Posted Date

Sep 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To clarify the mechanisms of Keloid scar formation.

Elucidate the action and therapeutic value of 5-FU in Keloid scar treatment

Identify the genetic link with Keloid scar formation.

Quantify the psychological/social impact in keloid scarring patients

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
5-Fluorouracil	Active Comparator	Patients with small keloidal scars to have intralesional 5FU injected	Drug: 5- fluorouracil
Radiotherapy	Active Comparator	Large keloid scars undergo extralesional excision and radiotherapy	Radiation: radiotherapy
TAC	Active Comparator		Drug: Triamcinolone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
5- fluorouracil	Drug	5mg of 5FU injected per 1cm square, at 6 week intervals for 30 weeks = 6 sessions	5-Fluorouracil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Keloid Scar Reduction	Using a 3D scanner to observe the reduction of the scar volume measured in cubic centimetres	18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult ( > 18 years old).
Keloid scarring present.
Able to understand and give informed consent.
Patients giving informed consent to donate keloidal or non-affected skin when that is redundant after a procedure (i.e. BBR, Abdominoplasty).
Patients with a strong familial pedigree of keloid scar formation.

Exclusion Criteria:

Open wound at or proximity of the lesion
- Infected lesion
- Pregnant or planning pregnancy in the near future
- Lactating (Breast Feeding)
- Abnormal renal or liver function tests
- Atrophic scars
- Patient under 18 years of age
- Immunocompromised
- OR immunosuppressed

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Barts and the London NHS Trust		London	UK	E1 1BB	United Kingdom

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D007627	Keloid

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

Intervention Browse Module

MeSH Terms

ID	Term
D005472	Fluorouracil
D011878	Radiotherapy
D014221	Triamcinolone

Ancestor Terms

ID	Term
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided