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NCT01295099 Clinical Trial

Keloid Scarring: Treatment and Pathophysiology

Keloid Scar Clinical Trial

Official title:
Keloid Scarring:A Randomized Clinical and Laboratory Based Study on the Treatment and Differentiation Factors of the Local Disease

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01295099
Other study ID # KS001
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated

Study information
Verified date October 2022
Source Queen Mary University of London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United Kingdom Barts and the London NHS Trust London UK

Sponsors (1)
Lead Sponsor Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Keloid Scar Reduction Using a 3D scanner to observe the reduction of the scar volume measured in cubic centimetres 18 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03693924 - A Retrospective Evaluation of Superficial Radiation Therapy (SRT) and Keloid Scars.
Completed NCT04016610 - Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment for the Treatment of Keloid Scar N/A
Completed NCT04786210 - Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid Phase 4
Not yet recruiting NCT02521402 - Pilot Study to Evaluate Clinical Outcomes With the Use of Biovance Following Keloid Scar Revision Surgery Phase 4
Active, not recruiting NCT01736969 - A Substantial Equivalence Study of RD04723 and Predicate Device N/A
Completed NCT01176877 - Assessing and Improving Patient Knowledge About Keloid Scars (Keloids) N/A
Recruiting NCT04184011 - Superficial Radiation Therapy (SRT) for the Treatment of Recurrent Keloid Scars

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