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Keloid Scarring: Treatment and Pathophysiology

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. 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
Information provided by:
Queen Mary University of London

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

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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

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

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

Information from the National Library of Medicine

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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

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

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 identifier (NCT number): NCT01295099

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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
Additional Information:
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Responsible Party: Prof. Simon Myers, Queen Mary University of London 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
genetic link
psychological impact
social impact
Additional relevant MeSH terms:
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Collagen Diseases
Connective Tissue Diseases
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists