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

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ClinicalTrials.gov Identifier: NCT02155439
Recruitment Status : Completed
First Posted : June 4, 2014
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Kristiina Hietanen, Tampere University Hospital

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

Condition or disease Intervention/treatment Phase
Keloidscars Drug: 5-fluorouracil Drug: Triamcinolone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Keloidscars With Intralesional Triamcinolone and 5-fluorouracil Injections-prospective, Randomized, Controlled Trial - Pilot Study
Actual Study Start Date : May 2014
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : January 2018


Arm Intervention/treatment
Active Comparator: Triamcinolone
kortikosteroid
Drug: 5-fluorouracil
antimitotic drug
Other Name: Fluorouracil Accord

Active Comparator: 5-fluorouracil
antimitotic drug
Drug: Triamcinolone
Other Name: Lederspan




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Concentration change of hemoglobin and melanin [ Time Frame: 0 week, 3 week, 6 week, 12 week, 1 year ]
    Camera analysis with spectrocutometry


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy, lactating, renal or liver failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02155439


Locations
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Finland
Tampere university hospital
Tampere, Finland, 33521
Sponsors and Collaborators
Tampere University Hospital
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Responsible Party: Kristiina Hietanen, MD, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT02155439    
Other Study ID Numbers: 140260M
2013-004512-22 ( EudraCT Number )
First Posted: June 4, 2014    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Keywords provided by Kristiina Hietanen, Tampere University Hospital:
Prospective, randomized controlled trial - pilot study
Additional relevant MeSH terms:
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Triamcinolone
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists