Mild Versus Potent Corticosteroids as Treatment for Phimosis in Children (TopSteP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Chelsea and Westminster NHS Foundation Trust.
Recruitment status was  Not yet recruiting
Information provided by:
Chelsea and Westminster NHS Foundation Trust Identifier:
First received: July 6, 2009
Last updated: July 13, 2009
Last verified: July 2009

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.

Condition Intervention Phase
Drug: hydrocortisone
Drug: Betamethasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Mild Versus Potent Topical Corticosteroids as Primary Treatment for Non-retractile Foreskin in Children.

Resource links provided by NLM:

Further study details as provided by Chelsea and Westminster NHS Foundation Trust:

Primary Outcome Measures:
  • Achievement of fully retractile foreskin with full exposure of glans at the end of therapy [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications of topical corticosteroids [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mild steroid
1%hydrocortisone for 8 weeks
Drug: hydrocortisone
1%hydrocortisone topical OD for 8 weeks
Experimental: Potent Steroid Drug: Betamethasone
Betamethasone 0.1% topical Od for 8weeks


Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children 2-16 with non-retractile foreskin

Exclusion Criteria:

  • BXO, balanitis, <2yrs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00933023

Contact: Anindya Niyogi, MBBS, MRCSEd +447785962158

United Kingdom
Chelsea and Westminster Hospital Not yet recruiting
London, United Kingdom
Principal Investigator: Anindya Niyogi, MBBS, MRCSEd         
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
Principal Investigator: Anindya Niyogi, MBBS, MRCSEd Research Fellow in Paediatric Surgery
  More Information

No publications provided

Responsible Party: Anindya Niyogi (Research Fellow), Chelsea and Westminster Hospital Identifier: NCT00933023     History of Changes
Other Study ID Numbers: TopSteP
Study First Received: July 6, 2009
Last Updated: July 13, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses processed this record on March 26, 2015