Keloidscars Clinical Trial
Official title:
Treatment of Keloidscars With Intralesional Triamcinolone and 5-fluorouracil Injections-prospective, Randomized, Controlled Trial - Pilot Study
| Verified date | April 2018 |
| Source | Tampere University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The aim of study is examine the efficacy of intralesional 5-fluorouracil injections in keloid disease treatment.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | January 2018 |
| Est. primary completion date | December 31, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility |
Inclusion Criteria: - Person who has a keloidscar which could be treated with injection treatment Exclusion Criteria: - Pregnancy, lactating, renal or liver failure |
| Country | Name | City | State |
|---|---|---|---|
| Finland | Tampere university hospital | Tampere |
| Lead Sponsor | Collaborator |
|---|---|
| Tampere University Hospital |
Finland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Inflammatory cells and their different populations, blood vessel density, fibroplast proliferation (KI67) and estrogenreseptor | immonuhistochemical analysis with punch biopsy | 0 week, 3 week, 6 week, 12 week, 1 year | |
| Primary | Symptoms (pain, itching) of keloids and appearance of keloid | Change from baseline symptoms of scars baseline at one year with POSAS score | baseline and one year | |
| Secondary | Concentration change of hemoglobin and melanin | Camera analysis with spectrocutometry | 0 week, 3 week, 6 week, 12 week, 1 year |