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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Oulu.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT01108198
First received: April 20, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted

April 20, 2010
April 20, 2010
October 2006
June 2011   (final data collection date for primary outcome measure)
Retractability of foreskin [ Time Frame: 4-16 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study
Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study in 98 Boys

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Phimosis
  • 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 Name: Novalan
  • 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
    Interventions:
    • Drug: Mometasone furoate cream
    • Drug: moisturizing cream
  • Placebo Comparator: moisturizer
    Interventions:
    • Drug: Mometasone furoate cream
    • Drug: moisturizing cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • non-retractable foreskin requiring treatment

Exclusion Criteria:

  • age under six years old, previous operation or steroid treatment for phimosis
Male
6 Years to 16 Years
No
Contact: Johanna Rättyä, M.D., Ph.D +358 8 315 2011 johanna.rattya@ppshp.fi
Finland
 
NCT01108198
1212
Not Provided
M.D. Johanna Rättyä, Oulu University Hospital, Department of Children and Adolescents
University of Oulu
Not Provided
Not Provided
University of Oulu
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP