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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
Sponsor:
Information provided by:
Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00933023
First received: July 6, 2009
Last updated: July 13, 2009
Last verified: July 2009
History of Changes
  Purpose

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
Phimosis
 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:

MedlinePlus related topics: Steroids
U.S. FDA Resources

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

  Eligibility

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

Inclusion Criteria:

  • Children 2-16 with non-retractile foreskin

Exclusion Criteria:

  • BXO, balanitis, <2yrs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933023

Contacts
Contact: Anindya Niyogi, MBBS, MRCSEd +447785962158 a_niyogi@yahoo.com

Locations
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
Investigators
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
ClinicalTrials.gov 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:
Phimosis
Penile Diseases
Genital Diseases, Male
Betamethasone-17,21-dipropionate
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Betamethasone
Hydrocortisone
Betamethasone sodium phosphate
Hydrocortisone-17-butyrate
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on May 23, 2013