NCT00933023

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

1 month

First QC Date

July 6, 2009

Last Update Submit

July 28, 2015

Conditions

Phimosis

Outcome Measures

Primary Outcomes (1)

  • Achievement of fully retractile foreskin with full exposure of glans at the end of therapy

    16 weeks

Secondary Outcomes (1)

  • Complications of topical corticosteroids

    16 weeks

Study Arms (2)

Mild steroid

EXPERIMENTAL

1%hydrocortisone for 8 weeks

Drug: hydrocortisone

Potent Steroid

EXPERIMENTAL
Drug: Betamethasone

Interventions

hydrocortisoneDRUG

1%hydrocortisone topical once daily for 8 weeks

Mild steroid
BetamethasoneDRUG

Betamethasone 0.1% topical once daily for 8weeks

Potent Steroid

Eligibility Criteria

Age2 Years - 16 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 2-16 with non-retractile foreskin

You may not qualify if:

  • Balanitis xerotica obliterans, balanitis, \<2yrs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chelsea and Westminster Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Phimosis

Interventions

HydrocortisoneBetamethasone

Condition Hierarchy (Ancestors)

Penile DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-HydroxycorticosteroidsPregnadienetriolsPregnadienesSteroids, Fluorinated

Study Officials

  • Anindya Niyogi, MBBS, MRCSEd

    Research Fellow in Paediatric Surgery

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

July 6, 2009

First Posted

July 7, 2009

Study Start

August 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

July 30, 2015

Record last verified: 2015-07

Locations

GB(1)