Keloid Scarring: Treatment and Pathophysiology

Queen Mary University of London

Status and phase: Withdrawn; Phase 4

Conditions: Keloid Scar

Treatments: Drug: 5- fluorouracil; Drug: Triamcinolone; Radiation: radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01295099

KS001

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

5-Fluorouracil

Active Comparator group

Description:

Patients with small keloidal scars to have intralesional 5FU injected

Treatment:

Drug: 5- fluorouracil

Radiotherapy

Active Comparator group

Description:

Large keloid scars undergo extralesional excision and radiotherapy

Treatment:

Radiation: radiotherapy

TAC

Active Comparator group

Treatment:

Drug: Triamcinolone