Keloid scars: Pathophysiology and treatment

Phase 1

• Conditions: Keloid scarring

• Registration Number: EUCTR2011-000626-29-GB
• Lead Sponsor: QUEEN MARY UNIVERSITY OF LONDO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-21
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Open wound at or proximity of the lesion 2. Infected lesion 3. Pregnant or planning pregnancy in the near future 4. Lactating (Breast Feeding) 5. Abnormal renal or liver function tests 6. Atrophic scars 7. Patient under 18yrs of age 8. Immunocompromissed OR immunosuppressed

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Refine our current keloid assessment, treatment, and outcome pathway Assess the efficacy of 5-FU in the treatment of keloid scaring .;Secondary Objective: Define the relative contribution of epidermal and dermal activation to keloid pathogenesis Assess the genetic basis of familial keloid scaring Translate safety and tolerability of different doses of 5-FU following extralesional excision to radiotherapy. Assess the efficacy of 5-FU in the treatment of keloid scaring comparing to TAC;Primary end point(s): Improving the treatment outcomes of Keloid scarring;Timepoint(s) of evaluation of this end point: Six months within the trial

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Refine the assesmment of scaring;Timepoint(s) of evaluation of this end point: End of trial