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Mild Versus Potent Corticosteroids as Treatment for Phimosis in Children

Information source: Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Phimosis

Intervention: hydrocortisone (Drug); Betamethasone (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: Chelsea and Westminster NHS Foundation Trust

Official(s) and/or principal investigator(s):
Anindya Niyogi, MBBS, MRCSEd, Principal Investigator, Affiliation: Research Fellow in Paediatric Surgery

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.

Clinical Details

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

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

Primary outcome: Achievement of fully retractile foreskin with full exposure of glans at the end of therapy

Secondary outcome: Complications of topical corticosteroids

Eligibility

Minimum age: 2 Years. Maximum age: 16 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Children 2-16 with non-retractile foreskin

Exclusion Criteria:

- Balanitis xerotica obliterans, balanitis, <2yrs

Locations and Contacts

Chelsea and Westminster Hospital, London, United Kingdom
Additional Information

Starting date: August 2009
Last updated: July 28, 2015

Page last updated: August 23, 2015

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