Mild Versus Potent Corticosteroids as Treatment for Phimosis in Children

Phase 4

Withdrawn

• Conditions: Phimosis
• Interventions: Drug: hydrocortisone; Drug: Betamethasone

• Registration Number: NCT00933023
• Lead Sponsor: Chelsea and Westminster NHS Foundation Trust

Brief Summary

Topical steroids are used as treatment for non-retractile foreskin in children for decades, but, there are disagreement among physicians about the optimum potency of the agent used. This study is designed to determine any difference in the beneficial effects of mild versus potent topical corticosteroids in treatment of non-retractile foreskin in children.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-06
• Study First Submitted QC: 2009-07-06
• Study First Posted: 2009-07-07
• Study Start: 2009-08
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-28
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Children 2-16 with non-retractile foreskin

Exclusion Criteria

• Balanitis xerotica obliterans, balanitis, <2yrs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mild steroid	hydrocortisone	1%hydrocortisone for 8 weeks
Potent Steroid	Betamethasone	-

Primary Outcome Measures

Name	Time	Method
Achievement of fully retractile foreskin with full exposure of glans at the end of therapy	16 weeks

Secondary Outcome Measures

Name	Time	Method
Complications of topical corticosteroids	16 weeks

Trial Locations

Locations (1)

Chelsea and Westminster Hospital; 🇬🇧 London, United Kingdom