Mild Versus Potent Corticosteroids as Treatment for Phimosis in Children

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00933023

Acronym

TopSteP

Enrollment

Registered

2009-07-07

Start date

2009-08-31

Completion date

2009-09-30

Last updated

2015-07-30

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

Conditions

Phimosis

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.

Interventions

DRUGhydrocortisone

1%hydrocortisone topical once daily for 8 weeks

DRUGBetamethasone

Betamethasone 0.1% topical once daily for 8weeks

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

2 Years to 16 Years

Healthy volunteers

Inclusion criteria

* Children 2-16 with non-retractile foreskin

Exclusion criteria

* Balanitis xerotica obliterans, balanitis, \<2yrs

Design outcomes

Primary

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

Secondary

Measure	Time frame
Complications of topical corticosteroids	16 weeks

Countries

United Kingdom

Outcome results

None listed

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