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WithdrawnNCT01295099Updated Sep 18, 2023

Keloid Scarring: Treatment and Pathophysiology

A Phase 4 interventional study of 5- fluorouracil and radiotherapy in Keloid Scar, sponsored by Queen Mary University of London. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-09-18.

Sponsored by Queen Mary University of London · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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

02

Conditions studied

  • Keloid Scar

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Keywords

  • scar formation
  • 5-FU
  • genetic link
  • psychological impact
  • social impact
03

In context

Keloid

138 studies on the registry are indexed under Keloid; 26 are open to participants now.

Browse Keloid studies →

Lead sponsor

Queen Mary University of London is the lead sponsor of 253 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult ( > 18 years old).
  • Keloid scarring present.
  • Able to understand and give .
  • 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

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
    • OR immunosuppressed
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    5-Fluorouracil

    Patients with small keloidal scars to have intralesional 5FU injected

    Drug: 5- fluorouracil

  • Active comparator
    Radiotherapy

    Large keloid scars undergo extralesional excision and radiotherapy

    Radiation: radiotherapy

  • Active comparator
    TAC

    Drug: Triamcinolone

Interventions

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

  • Radiationradiotherapy

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

  • TAC 10mg in 1ml injected intralesional

06

What researchers measure

Primary outcomes

  1. Keloid Scar Reduction

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

    Time frame: 18 months

07

Study locations

1 site
  • Barts and the London NHS Trust
    London, UK E1 1BB, United Kingdom
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01295099
Responsible party
Sponsor
First posted
Feb 14, 2011
Last update
Sep 18, 2023

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Fluorouracil · Triamcinolone

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