Keloid Scarring: Treatment and Pathophysiology

NCT ID: NCT01295099

Last Updated: 2023-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Keloid Scar

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

5-Fluorouracil

Patients with small keloidal scars to have intralesional 5FU injected

Group Type ACTIVE_COMPARATOR

5- fluorouracil

Intervention Type DRUG

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

Radiotherapy

Large keloid scars undergo extralesional excision and radiotherapy

Group Type ACTIVE_COMPARATOR

radiotherapy

Intervention Type RADIATION

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

TAC

Group Type ACTIVE_COMPARATOR

Triamcinolone

Intervention Type DRUG

TAC 10mg in 1ml injected intralesional

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

5- fluorouracil

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

Intervention Type DRUG

radiotherapy

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

Intervention Type RADIATION

Triamcinolone

TAC 10mg in 1ml injected intralesional

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Queen Mary University of London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Barts and the London NHS Trust

London, UK, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KS001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Radiotherapy for Keloids
NCT04722263 RECRUITING NA
Keloid Tissue Bank
NCT01425437 TERMINATED
Keloid Radiation Registry
NCT01457079 UNKNOWN