Keloid Scarring: Treatment and Pathophysiology

September 14, 2023 updated by: Queen Mary University of London

Keloid Scarring:A Randomized Clinical and Laboratory Based Study on the Treatment and Differentiation Factors of the Local Disease

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • UK
      • London, UK, United Kingdom, E1 1BB
        • Barts and The London NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 5-Fluorouracil
Patients with small keloidal scars to have intralesional 5FU injected
Drug: 5- fluorouracil
5mg of 5FU injected per 1cm square, at 6 week intervals for 30 weeks = 6 sessions
Active Comparator: Radiotherapy
Large keloid scars undergo extralesional excision and radiotherapy
Radiation: radiotherapy
after complete excision of keloid they have a single session of radiotherapy
Active Comparator: TAC
Drug: Triamcinolone
TAC 10mg in 1ml injected intralesional

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2015

Study Registration Dates

First Submitted

February 11, 2011

First Submitted That Met QC Criteria

February 11, 2011

First Posted (Estimated)

February 14, 2011

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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