Mild Versus Potent Corticosteroids as Treatment for Phimosis in Children

Phimosis Clinical Trial

— TopSteP  

Official title:

A Randomised Controlled Trial of Mild Versus Potent Topical Corticosteroids as Primary Treatment for Non-retractile Foreskin in Children.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00933023
• Other study ID #: TopSteP
• Status: Withdrawn
• Phase: Phase 4
• First received: July 6, 2009
• Last updated: July 28, 2015
• Start date: August 2009
• Est. completion date: September 2009

Study information

• Verified date: July 2015
• Source: Chelsea and Westminster NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 2 Years to 16 Years

Eligibility

Inclusion Criteria:

• Children 2-16 with non-retractile foreskin

Exclusion Criteria:

• Balanitis xerotica obliterans, balanitis, <2yrs

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phimosis

Intervention

Drug:
• hydrocortisone
1%hydrocortisone topical once daily for 8 weeks
• Betamethasone
Betamethasone 0.1% topical once daily for 8weeks

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Chelsea and Westminster NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of fully retractile foreskin with full exposure of glans at the end of therapy		16 weeks	No
Secondary	Complications of topical corticosteroids		16 weeks	No