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Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study

Sponsor
University of Oulu (Other)
Overall Status
Unknown status
CT.gov ID
NCT01108198
Collaborator
(none)
100
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

During last years topical steroid creams have been suggested to be effective treatment for non-retractable foreskin instead of circumcision.

Aim of this study is to investigate the efficacy, safety and persistence of treatment results of a medium potent steroid cream in a double-blind, randomized, placebo-controlled study.

Condition or Disease Intervention/Treatment Phase
  • Drug: Mometasone furoate cream
  • Drug: moisturizing cream
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study in 98 Boys
Study Start Date :
Oct 1, 2006
Anticipated Primary Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: mometasone furoate cream

The study patient consecutive patients who were referred to outpatient clinic of Pediatric surgery for surgical treatment of non-retractable foreskin. The study patients were randomized to have either mometasone cream or placebo

Drug: Mometasone furoate cream
Study cream was applicated once per day for 4-8 weeks.
Other Names:
  • Elocon
  • topical steroid cream

    • Drug: moisturizing cream
    study cream was applicated once per day for 4 to 8 weeks
    Other Names:
  • Novalan

    		•
    Placebo Comparator: moisturizer

    Drug: Mometasone furoate cream
    Study cream was applicated once per day for 4-8 weeks.
    Other Names:
  • Elocon
  • topical steroid cream

    • Drug: moisturizing cream
    study cream was applicated once per day for 4 to 8 weeks
    Other Names:
  • Novalan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Retractability of foreskin [4-16 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 16 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • non-retractable foreskin requiring treatment
    Exclusion Criteria:
    • age under six years old, previous operation or steroid treatment for phimosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oulu University Hospital, Department of Children and Adolescents Oulu Finland 90029

    Sponsors and Collaborators

    • University of Oulu

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01108198
    Other Study ID Numbers:
    • 1212
    First Posted:
    Apr 21, 2010
    Last Update Posted:
    Apr 21, 2010
    Last Verified:
    Apr 1, 2010
    Keywords provided by , ,
    phimosis,
    non-retractable foreskin
    topical steroids
    children
    Additional relevant MeSH terms:
    Phimosis
    Mometasone Furoate

    Study Results

    No Results Posted as of Apr 21, 2010