Treatment of Keloidscars With Intralesional Triamcinolone and 5-fluorouracil Injections-prospective, Randomized, Controlled Trial - Pilot Study

Phase 4

Completed

• Conditions: Keloidscars
• Interventions: Drug: Triamcinolone; Drug: 5-fluorouracil

• Registration Number: NCT02155439
• Lead Sponsor: Tampere University Hospital

Brief Summary

The aim of study is examine the efficacy of intralesional 5-fluorouracil injections in keloid disease treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-09
• Study Start: 2014-05
• Study First Submitted QC: 2014-06-02
• Study First Posted: 2014-06-04
• Primary Completion: 2017-12-31
• Study Completion: 2018-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-25
• Last Update Posted: 2018-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Person who has a keloidscar which could be treated with injection treatment

Exclusion Criteria

• Pregnancy, lactating, renal or liver failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5-fluorouracil	Triamcinolone	antimitotic drug
Triamcinolone	5-fluorouracil	kortikosteroid

Primary Outcome Measures

Name	Time	Method
Symptoms (pain, itching) of keloids and appearance of keloid	baseline and one year	Change from baseline symptoms of scars baseline at one year with POSAS score

Secondary Outcome Measures

Name	Time	Method
Concentration change of hemoglobin and melanin	0 week, 3 week, 6 week, 12 week, 1 year	Camera analysis with spectrocutometry

Trial Locations

Locations (1)

Tampere university hospital; 🇫🇮 Tampere, Finland