Overview

This trial is active, not recruiting.

Condition keloid
Treatments 5- fluorouracil, radiotherapy, triamcinolone
Phase phase 4
Sponsor Queen Mary University of London
Start date February 2011
End date January 2012
Trial size 100 participants
Trial identifier NCT01295099, KS001

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients with small keloidal scars to have intralesional 5FU injected
5- fluorouracil
5mg of 5FU injected per 1cm square, at 6 week intervals for 30 weeks = 6 sessions
(Active Comparator)
Large keloid scars undergo extralesional excision and radiotherapy
radiotherapy
after complete excision of keloid they have a single session of radiotherapy
(Active Comparator)
triamcinolone
TAC 10mg in 1ml injected intralesional

Primary Outcomes

Measure
Keloid Scar Reduction
time frame: 18 months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Keloid Scarring:A Randomized Clinical and Laboratory Based Study on the Treatment and Differentiation Factors of the Local Disease
Trial information was received from ClinicalTrials.gov and was last updated in February 2011.
Information provided to ClinicalTrials.gov by Queen Mary University of London.