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

April 25, 2018 updated by: Kristiina Hietanen, Tampere University Hospital
The aim of study is examine the efficacy of intralesional 5-fluorouracil injections in keloid disease treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33521
        • Tampere university Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy, lactating, renal or liver failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Triamcinolone
kortikosteroid
Drug: 5-fluorouracil
antimitotic drug
Other Names:
  • Fluorouracil Accord
Active Comparator: 5-fluorouracil
antimitotic drug
Drug: Triamcinolone
Other Names:
  • Lederspan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and one year

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

June 2, 2014

First Posted (Estimate)

June 4, 2014

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 140260M
  • 2013-004512-22 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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