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Status: Withdrawn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
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