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Keloid Scarring: Treatment and Pathophysiology

Primary Purpose

Keloid Scar

Status
Withdrawn
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
5- fluorouracil
radiotherapy
Triamcinolone
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloid Scar focused on measuring scar formation, 5-FU, genetic link, psychological impact, social impact

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barts and the London NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

5-Fluorouracil

Radiotherapy

TAC

Arm Description

Patients with small keloidal scars to have intralesional 5FU injected

Large keloid scars undergo extralesional excision and radiotherapy

Outcomes

Primary Outcome Measures

Keloid Scar Reduction
Using a 3D scanner to observe the reduction of the scar volume measured in cubic centimetres

Secondary Outcome Measures

Full Information

First Posted
February 11, 2011
Last Updated
September 14, 2023
Sponsor
Queen Mary University of London
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1. Study Identification

Unique Protocol Identification Number
NCT01295099
Brief Title
Keloid Scarring: Treatment and Pathophysiology
Official Title
Keloid Scarring:A Randomized Clinical and Laboratory Based Study on the Treatment and Differentiation Factors of the Local Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Mary University of London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid Scar
Keywords
scar formation, 5-FU, genetic link, psychological impact, social impact

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5-Fluorouracil
Arm Type
Active Comparator
Arm Description
Patients with small keloidal scars to have intralesional 5FU injected
Arm Title
Radiotherapy
Arm Type
Active Comparator
Arm Description
Large keloid scars undergo extralesional excision and radiotherapy
Arm Title
TAC
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
5- fluorouracil
Intervention Description
5mg of 5FU injected per 1cm square, at 6 week intervals for 30 weeks = 6 sessions
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
after complete excision of keloid they have a single session of radiotherapy
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Intervention Description
TAC 10mg in 1ml injected intralesional
Primary Outcome Measure Information:
Title
Keloid Scar Reduction
Description
Using a 3D scanner to observe the reduction of the scar volume measured in cubic centimetres
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Barts and the London NHS Trust
City
London
State/Province
UK
ZIP/Postal Code
E1 1BB
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.keloids.co.uk
Description
Related Info

Learn more about this trial

Keloid Scarring: Treatment and Pathophysiology

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