Back to resultsTreatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study
Primary Purpose
Phimosis
Status
Unknown status
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Mometasone furoate cream
moisturizing cream
Sponsored by
About this trial
This is an interventional treatment trial for Phimosis focused on measuring phimosis,, non-retractable foreskin, topical steroids, children
Eligibility Criteria
Inclusion Criteria:
- non-retractable foreskin requiring treatment
Exclusion Criteria:
- age under six years old, previous operation or steroid treatment for phimosis
Sites / Locations
- Oulu University Hospital, Department of Children and AdolescentsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
mometasone furoate cream
moisturizer
Arm Description
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
Outcomes
Primary Outcome Measures
Retractability of foreskin
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01108198
Brief Title
Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study
Official Title
Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study in 98 Boys
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Oulu
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phimosis
Keywords
phimosis,, non-retractable foreskin, topical steroids, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mometasone furoate cream
Arm Type
Active Comparator
Arm Description
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
Arm Title
moisturizer
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Mometasone furoate cream
Other Intervention Name(s)
Elocon, topical steroid cream
Intervention Description
Study cream was applicated once per day for 4-8 weeks.
Intervention Type
Drug
Intervention Name(s)
moisturizing cream
Other Intervention Name(s)
Novalan
Intervention Description
study cream was applicated once per day for 4 to 8 weeks
Primary Outcome Measure Information:
Title
Retractability of foreskin
Time Frame
4-16 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non-retractable foreskin requiring treatment
Exclusion Criteria:
age under six years old, previous operation or steroid treatment for phimosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johanna Rättyä, M.D., Ph.D
Phone
+358 8 315 2011
Email
johanna.rattya@ppshp.fi
Facility Information:
Facility Name
Oulu University Hospital, Department of Children and Adolescents
City
Oulu
ZIP/Postal Code
90029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna Rättyä, M.D, Ph.D.
Phone
+358 8 315 2011
Email
johanna.rattya@ppshp.fi
First Name & Middle Initial & Last Name & Degree
Johanna Rättyä, M.D, Ph.D.
12. IPD Sharing Statement
Learn more about this trial
Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study
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