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This study has been withdrawn prior to enrollment.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)

Sponsor:

Information provided by (Responsible Party):

Anindya Niyogi, Chelsea and Westminster NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT00933023

First received: July 6, 2009

Last updated: July 28, 2015

Last verified: July 2015

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

Drug Information available for: Hydrocortisone acetate Hydrocortisone Hydrocortisone sodium succinate Hydrocortisone cypionate Hydrocortisone valerate Hydrocortisone probutate Proctofoam-HC

U.S. FDA Resources

Further study details as provided by Anindya Niyogi, 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 ]

Secondary Outcome Measures:

Complications of topical corticosteroids [ Time Frame: 16 weeks ]


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

Eligibility


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

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 ClinicalTrials.gov identifier: 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
Study First Received:	July 6, 2009
Last Updated:	July 28, 2015

Additional relevant MeSH terms:


Phimosis Penile Diseases Genital Diseases, Male Hydrocortisone 17-butyrate 21-propionate Cortisol succinate Hydrocortisone acetate 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

ClinicalTrials.gov processed this record on July 14, 2017

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