CClinicalTrials.gg
WithdrawnNCT00933023TopStePUpdated Jul 30, 2015

Mild Versus Potent Corticosteroids as Treatment for Phimosis in Children

A Phase 4 interventional study of hydrocortisone and Betamethasone in Phimosis, sponsored by Chelsea and Westminster NHS Foundation Trust. Withdrawn at 1 site in United Kingdom. Open to male participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2015-07-30.

Sponsored by Chelsea and Westminster NHS Foundation Trust · Phase 4, Interventional, and Treatment

Why this study was withdrawn
Patient numbers estimated to be too low to complete the trial in less than 10 years
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
2 Years to 16 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Phimosis
03

In context

Lead sponsor

Chelsea and Westminster NHS Foundation Trust is the lead sponsor of 53 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 16 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Children 2-16 with non-retractile foreskin

Exclusion criteria

Exclusion Criteria:

  • Balanitis xerotica obliterans, balanitis, \<2yrs
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Mild steroid

    1%hydrocortisone for 8 weeks

    Drug: hydrocortisone

  • Experimental
    Potent Steroid

    Drug: Betamethasone

Interventions

  • Drughydrocortisone

    1%hydrocortisone topical once daily for 8 weeks

  • DrugBetamethasone

    Betamethasone 0.1% topical once daily for 8weeks

06

What researchers measure

Primary outcomes

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

    Time frame: 16 weeks

Secondary outcomes

  1. Complications of topical corticosteroids

    Time frame: 16 weeks

07

Study locations

1 site
  • Chelsea and Westminster Hospital
    London, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00933023
Lead sponsor
Chelsea and Westminster NHS Foundation Trust
Responsible party
Anindya Niyogi (Clinical Research Fellow, Chelsea and Westminster NHS Foundation Trust) — Principal investigator
First posted
Jul 7, 2009
Start date
Aug 2009
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Jul 30, 2015

Study contacts

Anindya Niyogi, MBBS, MRCSEd
principal investigator · Research Fellow in Paediatric Surgery

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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