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Keloid Scarring: Treatment and Pathophysiology

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Queen Mary University of London.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01295099
First Posted: February 14, 2011
Last Update Posted: February 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Queen Mary University of London
  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: None (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:


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

Primary Outcome Measures:
  • Keloid Scar Reduction [ Time Frame: 18 months ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Prof. Simon Myers, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01295099     History of Changes
Other Study ID Numbers: KS001
First Submitted: February 11, 2011
First Posted: February 14, 2011
Last Update Posted: February 14, 2011
Last Verified: February 2011

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

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