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

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ClinicalTrials.gov Identifier: NCT00933023
Recruitment Status : Withdrawn (Patient numbers estimated to be too low to complete the trial in less than 10 years)
First Posted : July 7, 2009
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Phimosis Drug: hydrocortisone Drug: Betamethasone Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : August 2009
Primary Completion Date : September 2009
Study Completion Date : September 2009


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Achievement of fully retractile foreskin with full exposure of glans at the end of therapy [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Complications of topical corticosteroids [ Time Frame: 16 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 2-16 with non-retractile foreskin

Exclusion Criteria:

  • Balanitis xerotica obliterans, balanitis, <2yrs
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933023


Locations
United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
Investigators
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
ClinicalTrials.gov Identifier: NCT00933023     History of Changes
Other Study ID Numbers: TopSteP
First Posted: July 7, 2009    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Phimosis
Penile Diseases
Genital Diseases, Male
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Hydrocortisone
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents