Back to resultsMild Versus Potent Corticosteroids as Treatment for Phimosis in Children (TopSteP)
Primary Purpose
Phimosis
Status
Withdrawn
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
hydrocortisone
Betamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Phimosis
Eligibility Criteria
Inclusion Criteria:
- Children 2-16 with non-retractile foreskin
Exclusion Criteria:
- Balanitis xerotica obliterans, balanitis, <2yrs
Sites / Locations
- Chelsea and Westminster Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mild steroid
Potent Steroid
Arm Description
1%hydrocortisone for 8 weeks
Outcomes
Primary Outcome Measures
Achievement of fully retractile foreskin with full exposure of glans at the end of therapy
Secondary Outcome Measures
Complications of topical corticosteroids
Full Information
NCT ID
NCT00933023
First Posted
July 6, 2009
Last Updated
July 28, 2015
Sponsor
Chelsea and Westminster NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT00933023
Brief Title
Mild Versus Potent Corticosteroids as Treatment for Phimosis in Children
Acronym
TopSteP
Official Title
A Randomised Controlled Trial of Mild Versus Potent Topical Corticosteroids as Primary Treatment for Non-retractile Foreskin in Children.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Patient numbers estimated to be too low to complete the trial in less than 10 years
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chelsea and Westminster NHS Foundation Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phimosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mild steroid
Arm Type
Experimental
Arm Description
1%hydrocortisone for 8 weeks
Arm Title
Potent Steroid
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
hydrocortisone
Intervention Description
1%hydrocortisone topical once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Betamethasone
Intervention Description
Betamethasone 0.1% topical once daily for 8weeks
Primary Outcome Measure Information:
Title
Achievement of fully retractile foreskin with full exposure of glans at the end of therapy
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Complications of topical corticosteroids
Time Frame
16 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children 2-16 with non-retractile foreskin
Exclusion Criteria:
Balanitis xerotica obliterans, balanitis, <2yrs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anindya Niyogi, MBBS, MRCSEd
Organizational Affiliation
Research Fellow in Paediatric Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chelsea and Westminster Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Mild Versus Potent Corticosteroids as Treatment for Phimosis in Children
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