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NCT01108198 Clinical Trial

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

Phimosis Clinical Trial

Official title:
Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study in 98 Boys

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01108198
Other study ID # 1212
Secondary ID
Status Recruiting
Phase Phase 4
First received April 20, 2010
Last updated April 20, 2010
Start date October 2006

Study information
Verified date April 2010
Source University of Oulu
Contact Johanna Rättyä, M.D., Ph.D
Phone +358 8 315 2011
Email johanna.rattya@ppshp.fi
Is FDA regulated No
Health authority Finland: Finnish Medicines Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Male
Age group 6 Years to 16 Years
Eligibility Inclusion Criteria:

- non-retractable foreskin requiring treatment

Exclusion Criteria:

- age under six years old, previous operation or steroid treatment for phimosis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Mometasone furoate cream
Study cream was applicated once per day for 4-8 weeks.
• moisturizing cream
study cream was applicated once per day for 4 to 8 weeks

Locations
Country Name City State
Finland Oulu University Hospital, Department of Children and Adolescents Oulu

Sponsors (1)
Lead Sponsor Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Retractability of foreskin 4-16 weeks Yes
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