KeloidscarsPhase 4NCT02155439
Treatment of Keloidscars With Intralesional Triamcinolone and 5-fluorouracil Injections-prospective, Randomized, Controlled Trial - Pilot Study
A Phase 4 study testing 5-fluorouracil and Triamcinolone in people with Keloidscars, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The aim of study is examine the efficacy of intralesional 5-fluorouracil injections in keloid disease treatment. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Keloidscars
- What is being tested?
- 5-fluorouracil and Triamcinolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- May 2014to Jan 2018
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Person who has a keloidscar which could be treated with injection treatment
Who cannot join
- Pregnancy, lactating, renal or liver failure
Trial locations and contacts
1 site in 1 country.
About this study
The aim of study is examine the efficacy of intralesional 5-fluorouracil injections in keloid disease treatment.
- Conditions
- Keloidscars
- Being tested
- 5-fluorouracil, Triamcinolone
- Keywords
- Prospective, randomized controlled trial - pilot study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-fluorouracilDrug
Also called Fluorouracil Accord
antimitotic drug
TriamcinoloneDrug
Also called Lederspan
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone | Active comparator | kortikosteroid Receives: Drug: 5-fluorouracil |
| 5-fluorouracil | Active comparator | antimitotic drug Receives: Drug: Triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms (pain, itching) of keloids and appearance of keloid
Change from baseline symptoms of scars baseline at one year with POSAS score
Measured: baseline and one year
Secondary outcomes (1)
Concentration change of hemoglobin and melanin
Camera analysis with spectrocutometry
Measured: 0 week, 3 week, 6 week, 12 week, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startMay 2014
- Primary completion31 Dec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidscarsStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristiina Hietanen, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155439
- Sponsor's protocol ID
- 140260M
- Other IDs
- 2013-004512-22
- Status last verified
- Apr 2018
- First submitted
- 9 Apr 2014
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Keloidscars With Intralesional Triamcinolone and 5-fluorouracil Injections-prospective, Randomized, Controlled Trial - Pilot Study
- ClinicalTrials.gov ID
- NCT02155439
- Acronym / sponsor ID
- 140260M
- Conditions
- Keloidscars
- Keywords
- Prospective, randomized controlled trial - pilot study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 4 Jun 2014 (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.
The aim of study is examine the efficacy of intralesional 5-fluorouracil injections in keloid disease treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone | Active comparator | Drug: 5-fluorouracilkortikosteroid |
| 5-fluorouracil | Active comparator | Drug: Triamcinoloneantimitotic drug |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Person who has a keloidscar which could be treated with injection treatment
Key exclusion criteria (1 listed)
- Pregnancy, lactating, renal or liver failure
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-fluorouracilAlso: Fluorouracil Accordantimitotic drug | Drug | Triamcinolone |
| TriamcinoloneAlso: Lederspan | Drug | 5-fluorouracil |
Primary outcome
Symptoms (pain, itching) of keloids and appearance of keloid
Time frame: baseline and one year
Change from baseline symptoms of scars baseline at one year with POSAS score
1 secondary outcome
Concentration change of hemoglobin and melanin
Time frame: 0 week, 3 week, 6 week, 12 week, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
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 and Triamcinolone in people with Keloidscars, run by Tampere University Hospital at 1 site in Finland.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Apr 2018. 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 Finland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Symptoms (pain, itching) of keloids and appearance of keloid (time frame: baseline and one year). 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 26 Apr 2018.