PhimosisPhase 4NCT01108198
Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study
A Phase 4 study testing Mometasone furoate cream and moisturizing cream in people with Phimosis, run by University of Oulu at 1 site in Finland.
Trial summary
During last years topical steroid creams have been suggested to be effective treatment for non-retractable foreskin instead of circumcision. Aim of this study is to investigate the efficacy, safety and persistence of treatment results of a medium potent steroid cream in a double-blind, randomized, placebo-controlled… Read more about this study
- Who is it for?
- Ages 6 to 16 years, men only
- Conditions the study is for
- Phimosis
- What is being tested?
- Mometasone furoate cream and moisturizing cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2006to Jun 2011
- 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 6 to 16 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- non-retractable foreskin requiring treatment
Who cannot join
- age under six years old, previous operation or steroid treatment for phimosis
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Oulu University Hospital, Department of Children and Adolescents
Oulu, 90029
Johanna Rättyä, M.D, Ph.D., +358 8 315 2011, johanna.rattya@ppshp.fi
Johanna Rättyä, M.D, Ph.D.
About this study
Official title: Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study in 98 Boys
During last years topical steroid creams have been suggested to be effective treatment for non-retractable foreskin instead of circumcision.
Aim of this study is to investigate the efficacy, safety and persistence of treatment results of a medium potent steroid cream in a double-blind, randomized, placebo-controlled study.
- Conditions
- Phimosis
- Being tested
- Mometasone furoate cream, moisturizing cream
- Keywords
- phimosis,, non-retractable foreskin, topical steroids, children
- Medical subject headings
- Phimosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone furoate creamDrug
Also called Elocon, topical steroid cream
Study cream was applicated once per day for 4-8 weeks.
moisturizing creamDrug
Also called Novalan
study cream was applicated once per day for 4 to 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| mometasone furoate cream | Active comparator | The study patient consecutive patients who were referred to outpatient clinic of Pediatric surgery for surgical treatment of non-retractable foreskin. The study patients were randomized to have either mometasone cream or placebo Receives: Drug: Mometasone furoate cream; Drug: moisturizing cream |
| moisturizer | Placebo comparator | Not described Receives: Drug: Mometasone furoate cream; Drug: moisturizing cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retractability of foreskin
Measured: 4-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startOct 2006
- Primary completionJun 2011 (estimated)
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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108198
- Sponsor's protocol ID
- 1212
- Status last verified
- Apr 2010
- First submitted
- 20 Apr 2010
- Last updated
- 21 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study in 98 Boys
- ClinicalTrials.gov ID
- NCT01108198
- Acronym / sponsor ID
- 1212
- Conditions
- Phimosis
- Keywords
- phimosis,, non-retractable foreskin, topical steroids, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jun 2011 (estimated)
- First posted
- 21 Apr 2010 (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.
During last years topical steroid creams have been suggested to be effective treatment for non-retractable foreskin instead of circumcision.
Aim of this study is to investigate the efficacy, safety and persistence of treatment results of a medium potent steroid cream in a double-blind, randomized, placebo-controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mometasone furoate cream | Active comparator | Drug: Mometasone furoate cream, Drug: moisturizing creamThe study patient consecutive patients who were referred to outpatient clinic of Pediatric surgery for surgical treatment of non-retractable foreskin. The study patients were randomized to have either mometasone cream or placebo |
| moisturizer | Placebo comparator | Drug: Mometasone furoate cream, Drug: moisturizing cream |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- non-retractable foreskin requiring treatment
Key exclusion criteria (1 listed)
- age under six years old, previous operation or steroid treatment for phimosis
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 |
|---|---|---|
| Mometasone furoate creamAlso: Elocon, topical steroid creamStudy cream was applicated once per day for 4-8 weeks. | Drug | moisturizer, mometasone furoate cream |
| moisturizing creamAlso: Novalanstudy cream was applicated once per day for 4 to 8 weeks | Drug | moisturizer, mometasone furoate cream |
Primary outcome
Retractability of foreskin
Time frame: 4-16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2010.
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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.
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 Mometasone furoate cream and moisturizing cream in people with Phimosis, run by University of Oulu at 1 site in Finland.
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: status not confirmed, as of the sponsor's last update on 21 Apr 2010. 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 Finland. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johanna Rättyä, M.D., Ph.D (+358 8 315 2011, johanna.rattya@ppshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retractability of foreskin (time frame: 4-16 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 21 Apr 2010.