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Keloid Scarring: Treatment and Pathophysiology

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ClinicalTrials.gov Identifier: NCT01295099
Recruitment Status : Unknown
Verified February 2011 by Queen Mary University of London.
Recruitment status was:  Active, not recruiting
First Posted : February 14, 2011
Last Update Posted : February 14, 2011
Sponsor:
Information provided by:
Queen Mary University of London

Study Description
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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


Condition or disease Intervention/treatment Phase
Keloid Drug: 5- fluorouracil Radiation: radiotherapy Drug: Triamcinolone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : February 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Keloid Scar Reduction [ Time Frame: 18 months ]
    Using a 3D scanner to observe the reduction of the scar volume measured in cubic centimetres


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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
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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
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United Kingdom
Barts and the London NHS Trust
London, UK, United Kingdom, E1 1BB
Sponsors and Collaborators
Queen Mary University of London
More Information
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Responsible Party: Prof. Simon Myers, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01295099    
Other Study ID Numbers: KS001
First Posted: February 14, 2011    Key Record Dates
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:
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Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes
Triamcinolone
Fluorouracil
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