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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

Tracking Information
First Submitted Date  ICMJE February 11, 2011
First Posted Date  ICMJE February 14, 2011
Last Update Posted Date February 14, 2011
Study Start Date  ICMJE February 2011
Estimated Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2011)
Keloid Scar Reduction [ Time Frame: 18 months ]
Using a 3D scanner to observe the reduction of the scar volume measured in cubic centimetres
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Keloid Scarring: Treatment and Pathophysiology
Official Title  ICMJE Keloid Scarring:A Randomized Clinical and Laboratory Based Study on the Treatment and Differentiation Factors of the Local Disease
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Keloid
Intervention  ICMJE
  • Drug: 5- fluorouracil
    5mg of 5FU injected per 1cm square, at 6 week intervals for 30 weeks = 6 sessions
  • Radiation: radiotherapy
    after complete excision of keloid they have a single session of radiotherapy
  • Drug: Triamcinolone
    TAC 10mg in 1ml injected intralesional
Study Arms  ICMJE
  • Active Comparator: 5-Fluorouracil
    Patients with small keloidal scars to have intralesional 5FU injected
    Intervention: Drug: 5- fluorouracil
  • Active Comparator: Radiotherapy
    Large keloid scars undergo extralesional excision and radiotherapy
    Intervention: Radiation: radiotherapy
  • Active Comparator: TAC
    Intervention: Drug: Triamcinolone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 11, 2011)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2015
Estimated Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01295099
Other Study ID Numbers  ICMJE KS001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Simon Myers, Queen Mary University of London
Study Sponsor  ICMJE Queen Mary University of London
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Queen Mary University of London
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP