NCT01295099

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
Last Updated

September 18, 2023

Status Verified

October 1, 2022

First QC Date

February 11, 2011

Last Update Submit

September 14, 2023

Conditions

Keloid Scar

Keywords

scar formation5-FUgenetic linkpsychological impactsocial impact

Outcome Measures

Primary Outcomes (1)

  • Keloid Scar Reduction

    Using a 3D scanner to observe the reduction of the scar volume measured in cubic centimetres

    18 months

Study Arms (3)

5-Fluorouracil

ACTIVE COMPARATOR

Patients with small keloidal scars to have intralesional 5FU injected

Drug: 5- fluorouracil

Radiotherapy

ACTIVE COMPARATOR

Large keloid scars undergo extralesional excision and radiotherapy

Radiation: radiotherapy

TAC

ACTIVE COMPARATOR
Drug: Triamcinolone

Interventions

5- fluorouracilDRUG

5mg of 5FU injected per 1cm square, at 6 week intervals for 30 weeks = 6 sessions

5-Fluorouracil
radiotherapyRADIATION

after complete excision of keloid they have a single session of radiotherapy

Radiotherapy
TriamcinoloneDRUG

TAC 10mg in 1ml injected intralesional

TAC

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barts and the London NHS Trust

London, UK, E1 1BB, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Keloid

Interventions

FluorouracilRadiotherapyTriamcinolone

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeuticsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2011

First Posted

February 14, 2011

Last Updated

September 18, 2023

Record last verified: 2022-10

Locations

GB(1)