Keloid ScarPhase 4NCT01295099
Keloid Scarring: Treatment and Pathophysiology
A Phase 4 study testing 5- fluorouracil, radiotherapy and Triamcinolone in people with Keloid Scar, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Keloid Scar
- What is being tested?
- 5- fluorouracil, radiotherapy and Triamcinolone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Patient under 18 years of age
- Immunocompromised
- OR immunosuppressed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Keloid Scarring:A Randomized Clinical and Laboratory Based Study on the Treatment and Differentiation Factors of the Local Disease
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
- Conditions
- Keloid Scar
- Being tested
- 5- fluorouracil, radiotherapy, Triamcinolone
- Keywords
- scar formation, 5-FU, genetic link, psychological impact, social impact
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5- fluorouracilDrug
5mg of 5FU injected per 1cm square, at 6 week intervals for 30 weeks = 6 sessions
radiotherapyRadiation
after complete excision of keloid they have a single session of radiotherapy
TriamcinoloneDrug
TAC 10mg in 1ml injected intralesional
| Study group | Role | What they receive |
|---|---|---|
| 5-Fluorouracil | Active comparator | Patients with small keloidal scars to have intralesional 5FU injected Receives: Drug: 5- fluorouracil |
| Radiotherapy | Active comparator | Large keloid scars undergo extralesional excision and radiotherapy Receives: Radiation: radiotherapy |
| TAC | Active comparator | Not described Receives: Drug: Triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keloid Scar Reduction
Using a 3D scanner to observe the reduction of the scar volume measured in cubic centimetres
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keloid ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295099
- Sponsor's protocol ID
- KS001
- Status last verified
- Oct 2022
- First submitted
- 11 Feb 2011
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keloid Scarring:A Randomized Clinical and Laboratory Based Study on the Treatment and Differentiation Factors of the Local Disease
- ClinicalTrials.gov ID
- NCT01295099
- Acronym / sponsor ID
- KS001
- Conditions
- Keloid Scar
- Keywords
- scar formation, 5-FU, genetic link, psychological impact, social impact
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- First posted
- 14 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5-Fluorouracil | Active comparator | Drug: 5- fluorouracilPatients with small keloidal scars to have intralesional 5FU injected |
| Radiotherapy | Active comparator | Radiation: radiotherapyLarge keloid scars undergo extralesional excision and radiotherapy |
| TAC | Active comparator | Drug: Triamcinolone |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Open wound at or proximity of the lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5- fluorouracil5mg of 5FU injected per 1cm square, at 6 week intervals for 30 weeks = 6 sessions | Drug | 5-Fluorouracil |
| radiotherapyafter complete excision of keloid they have a single session of radiotherapy | Radiation | Radiotherapy |
| TriamcinoloneTAC 10mg in 1ml injected intralesional | Drug | TAC |
Primary outcome
Keloid Scar Reduction
Time frame: 18 months
Using a 3D scanner to observe the reduction of the scar volume measured in cubic centimetres
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5- fluorouracil, radiotherapy and Triamcinolone in people with Keloid Scar, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Keloid Scar Reduction (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023; AzTrials last refreshed its copy on 31 Oct 2026.