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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01108198
Enrollment
100
Registered
2010-04-21
Start date
2006-10-31
Completion date
Unknown
Last updated
2010-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phimosis

Keywords

phimosis,, non-retractable foreskin, topical steroids, children

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.

Interventions

DRUGMometasone furoate cream

Study cream was applicated once per day for 4-8 weeks.

DRUGmoisturizing cream

study cream was applicated once per day for 4 to 8 weeks

Sponsors

University of Oulu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
6 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

* non-retractable foreskin requiring treatment

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Retractability of foreskin4-16 weeks

Countries

Finland

Contacts

Primary ContactJohanna Rättyä, M.D., Ph.D
johanna.rattya@ppshp.fi+358 8 315 2011

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026