PhimosisPhase 4TopStePNCT00933023
Mild Versus Potent Corticosteroids as Treatment for Phimosis in Children
A Phase 4 study testing hydrocortisone and Betamethasone in people with Phimosis, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 16 years, men only
- Conditions the study is for
- Phimosis
- What is being tested?
- hydrocortisone and Betamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2009to Sep 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Children 2-16 with non-retractile foreskin
Who cannot join
- Balanitis xerotica obliterans, balanitis, <2yrs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of Mild Versus Potent Topical Corticosteroids as Primary Treatment for Non-retractile Foreskin in Children.
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.
- Conditions
- Phimosis
- Being tested
- hydrocortisone, Betamethasone
- Medical subject headings
- Phimosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocortisoneDrug
1%hydrocortisone topical once daily for 8 weeks
BetamethasoneDrug
Betamethasone 0.1% topical once daily for 8weeks
| Study group | Role | What they receive |
|---|---|---|
| Mild steroid | Experimental | 1%hydrocortisone for 8 weeks Receives: Drug: hydrocortisone |
| Potent Steroid | Experimental | Not described Receives: Drug: Betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of fully retractile foreskin with full exposure of glans at the end of therapy
Measured: 16 weeks
Secondary outcomes (1)
Complications of topical corticosteroids
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Patient numbers estimated to be too low to complete the trial in less than 10 years
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhimosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anindya Niyogi, Chelsea and Westminster NHS Foundation Trust
- Investigators
- Anindya Niyogi, MBBS, MRCSEd, Principal investigator, Research Fellow in Paediatric Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933023
- Sponsor's protocol ID
- TopSteP
- Acronym
- TopSteP
- Status last verified
- Jul 2015
- First submitted
- 6 Jul 2009
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Mild Versus Potent Topical Corticosteroids as Primary Treatment for Non-retractile Foreskin in Children.
- ClinicalTrials.gov ID
- NCT00933023
- Acronym / sponsor ID
- TopSteP / TopSteP
- Conditions
- Phimosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Patient numbers estimated to be too low to complete the trial in less than 10 years
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 7 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild steroid | Experimental | Drug: hydrocortisone1%hydrocortisone for 8 weeks |
| Potent Steroid | Experimental | Drug: Betamethasone |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 2-16 with non-retractile foreskin
Key exclusion criteria (1 listed)
- Balanitis xerotica obliterans, balanitis, <2yrs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrocortisone1%hydrocortisone topical once daily for 8 weeks | Drug | Mild steroid |
| BetamethasoneBetamethasone 0.1% topical once daily for 8weeks | Drug | Potent Steroid |
Primary outcome
Achievement of fully retractile foreskin with full exposure of glans at the end of therapy
Time frame: 16 weeks
1 secondary outcome
Complications of topical corticosteroids
Time frame: 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
Related trials for Phimosis
Recruiting
Outcome of Two Surgical Methods for IOLImplantation in Eyes With Pseudoexfoliation Syndrome
Age Related Cataracts, Pseudoexfoliation Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anindya Niyogi, MBBS, MRCSEd principal investigator
Research Fellow in Paediatric Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hydrocortisone and Betamethasone in people with Phimosis, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of fully retractile foreskin with full exposure of glans at the end of therapy (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.