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

This study has been withdrawn prior to enrollment.
(Patient numbers estimated to be too low to complete the trial in less than 10 years)
Information provided by (Responsible Party):
Anindya Niyogi, Chelsea and Westminster NHS Foundation Trust Identifier:
First received: July 6, 2009
Last updated: July 28, 2015
Last verified: July 2015
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 ]

Enrollment: 0
Study Start Date: August 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mild steroid
1%hydrocortisone for 8 weeks
Drug: hydrocortisone
1%hydrocortisone topical once daily for 8 weeks
Experimental: Potent Steroid Drug: Betamethasone
Betamethasone 0.1% topical once daily 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:

  • Balanitis xerotica obliterans, balanitis, <2yrs
  Contacts and Locations
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Please refer to this study by its identifier: NCT00933023

United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
Principal Investigator: Anindya Niyogi, MBBS, MRCSEd Research Fellow in Paediatric Surgery
  More Information

Responsible Party: Anindya Niyogi, Clinical Research Fellow, Chelsea and Westminster NHS Foundation Trust Identifier: NCT00933023     History of Changes
Other Study ID Numbers: TopSteP 
Study First Received: July 6, 2009
Last Updated: July 28, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Genital Diseases, Male
Penile Diseases
Cortisol succinate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Dermatologic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Respiratory System Agents processed this record on May 22, 2016