NCT02155439

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 4, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

3.7 years

First QC Date

April 9, 2014

Last Update Submit

April 25, 2018

Conditions

Keloidscars

Keywords

Prospective, randomized controlled trial - pilot study

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Concentration change of hemoglobin and melanin

    0 week, 3 week, 6 week, 12 week, 1 year

Other Outcomes (1)

  • Inflammatory cells and their different populations, blood vessel density, fibroplast proliferation (KI67) and estrogenreseptor

    0 week, 3 week, 6 week, 12 week, 1 year

Study Arms (2)

Triamcinolone

ACTIVE COMPARATOR

kortikosteroid

Drug: 5-fluorouracil

5-fluorouracil

ACTIVE COMPARATOR

antimitotic drug

Drug: Triamcinolone

Interventions

5-fluorouracilDRUG

antimitotic drug

Also known as: Fluorouracil Accord
Triamcinolone
TriamcinoloneDRUG
Also known as: Lederspan
5-fluorouracil

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy, lactating, renal or liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere university hospital

Tampere, 33521, Finland

Location

MeSH Terms

Interventions

FluorouracilTriamcinolone

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 9, 2014

First Posted

June 4, 2014

Study Start

May 1, 2014

Primary Completion

December 31, 2017

Study Completion

January 1, 2018

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

FI(1)