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Withdrawn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
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
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
NCT ID
NCT01295099
First Posted
February 11, 2011
Last Updated
September 14, 2023
Sponsor
Queen Mary University of London
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Withdrawn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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