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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02155439

Enrollment

Registered

2014-06-04

Start date

2014-05-31

Completion date

2018-01-31

Last updated

2018-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keloidscars

Keywords

Prospective, randomized controlled trial - pilot study

Brief summary

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

Interventions

DRUG5-fluorouracil

antimitotic drug

DRUGTriamcinolone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Pregnancy, lactating, renal or liver failure

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Concentration change of hemoglobin and melanin	0 week, 3 week, 6 week, 12 week, 1 year	Camera analysis with spectrocutometry

Other

Measure	Time frame	Description
Inflammatory cells and their different populations, blood vessel density, fibroplast proliferation (KI67) and estrogenreseptor	0 week, 3 week, 6 week, 12 week, 1 year	immonuhistochemical analysis with punch biopsy

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026