Keloid scars: Pathophysiology and treatment

Keloid Scars: A randomised clinical and laboratory based study on the treatment and differentiation factors of the local disease - Keloid scars: Pathophysiology and treatment

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000626-29-GB

Enrollment

100

Registered

2011-10-21

Start date

2011-12-13

Completion date

Unknown

Last updated

2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keloid scarring

Interventions

Trade Name: 5 Fluorouracil Product Name: 5-fluorouracil Product Code: 5-FU Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion 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. 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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): Refine the assesmment of scaring;Timepoint(s) of evaluation of this end point: End of trial	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026