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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
Recruitment status was: Active, not recruiting
Sponsor:
Queen Mary University of London
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
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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| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01295099
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:
| 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 |
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 |
ClinicalTrials.gov processed this record on August 18, 2017