Mild Versus Potent Corticosteroids as Treatment for Phimosis in Children

NCT ID: NCT00933023

Last Updated: 2015-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Phimosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mild steroid

1%hydrocortisone for 8 weeks

Group Type EXPERIMENTAL

hydrocortisone

Intervention Type DRUG

1%hydrocortisone topical once daily for 8 weeks

Potent Steroid

Group Type EXPERIMENTAL

Betamethasone

Intervention Type DRUG

Betamethasone 0.1% topical once daily for 8weeks

Interventions

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hydrocortisone

1%hydrocortisone topical once daily for 8 weeks

Intervention Type DRUG

Betamethasone

Betamethasone 0.1% topical once daily for 8weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Children 2-16 with non-retractile foreskin

Exclusion Criteria

* Balanitis xerotica obliterans, balanitis, \<2yrs
Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Chelsea and Westminster NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Anindya Niyogi

Clinical Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anindya Niyogi, MBBS, MRCSEd

Role: PRINCIPAL_INVESTIGATOR

Research Fellow in Paediatric Surgery

Locations

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Chelsea and Westminster Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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TopSteP

Identifier Type: -

Identifier Source: org_study_id

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