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Keloid Scarring: Treatment and Pathophysiology

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT01295099
First received: February 11, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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


Condition Intervention Phase
Keloid
 Drug: 5- fluorouracil
Radiation: radiotherapy
Drug: Triamcinolone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Keloid Scarring:A Randomized Clinical and Laboratory Based Study on the Treatment and Differentiation Factors of the Local Disease

Resource links provided by NLM:

MedlinePlus related topics: Scars
U.S. FDA Resources

Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • Keloid Scar Reduction [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Using a 3D scanner to observe the reduction of the scar volume measured in cubic centimetres


Estimated Enrollment: 100
Study Start Date: February 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295099

Locations
United Kingdom
Barts and the London NHS Trust
London, UK, United Kingdom, E1 1BB
Sponsors and Collaborators
Queen Mary University of London
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Prof. Simon Myers, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01295099     History of Changes
Other Study ID Numbers: KS001
Study First Received: February 11, 2011
Last Updated: February 11, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Queen Mary University of London:
scar formation
5-FU
genetic link
psychological impact
social impact

Additional relevant MeSH terms:
Cicatrix
Keloid
Fibrosis
Pathologic Processes
Collagen Diseases
Connective Tissue Diseases
Fluorouracil
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone diacetate
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013