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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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Recruitment Status : Withdrawn (Patient numbers estimated to be too low to complete the trial in less than 10 years)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
Information provided by (Responsible Party):
Anindya Niyogi, Chelsea and Westminster NHS Foundation Trust

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

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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
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

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

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 ]

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

Inclusion Criteria:

  • Children 2-16 with non-retractile foreskin

Exclusion Criteria:

  • Balanitis xerotica obliterans, balanitis, <2yrs

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 identifier (NCT number): NCT00933023

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

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Responsible Party: Anindya Niyogi, Clinical Research Fellow, Chelsea and Westminster NHS Foundation Trust 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:
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Penile Diseases
Genital Diseases, Male
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents