Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study in 98 Boys
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- University of Oulu
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Retractability of foreskin
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 16 Years (Child)
- Sex
- 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
Arms & Interventions
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
Intervention: Mometasone furoate cream (Drug)
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
Intervention: moisturizing cream (Drug)
moisturizer
Intervention: Mometasone furoate cream (Drug)
moisturizer
Intervention: moisturizing cream (Drug)
Outcomes
Primary Outcomes
Retractability of foreskin
Time Frame: 4-16 weeks
Secondary Outcomes
No secondary outcomes reported