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Trial record 1 of 6 for:
"Phimosis"
Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by University of Oulu.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
University of Oulu
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT01108198
First received: April 20, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Phimosis | Drug: Mometasone furoate cream Drug: moisturizing cream | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study in 98 Boys |
Resource links provided by NLM:
Further study details as provided by University of Oulu:
Primary Outcome Measures:
- Retractability of foreskin [ Time Frame: 4-16 weeks ]
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2006 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: mometasone furoate cream
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
|
Drug: Mometasone furoate cream
Study cream was applicated once per day for 4-8 weeks.
Other Names:
Drug: moisturizing cream
study cream was applicated once per day for 4 to 8 weeks
Other Name: Novalan
|
| Placebo Comparator: moisturizer |
Drug: Mometasone furoate cream
Study cream was applicated once per day for 4-8 weeks.
Other Names:
Drug: moisturizing cream
study cream was applicated once per day for 4 to 8 weeks
Other Name: Novalan
|
Eligibility| Ages Eligible for Study: | 6 Years to 16 Years (Child) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- non-retractable foreskin requiring treatment
Exclusion Criteria:
- age under six years old, previous operation or steroid treatment for phimosis
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108198
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108198
Contacts
| Contact: Johanna Rättyä, M.D., Ph.D | +358 8 315 2011 | johanna.rattya@ppshp.fi |
Locations
| Finland | |
| Oulu University Hospital, Department of Children and Adolescents | Recruiting |
| Oulu, Finland, 90029 | |
| Contact: Johanna Rättyä, M.D, Ph.D. +358 8 315 2011 johanna.rattya@ppshp.fi | |
| Principal Investigator: Johanna Rättyä, M.D, Ph.D. | |
Sponsors and Collaborators
University of Oulu
More Information
| Responsible Party: | M.D. Johanna Rättyä, Oulu University Hospital, Department of Children and Adolescents |
| ClinicalTrials.gov Identifier: | NCT01108198 History of Changes |
| Other Study ID Numbers: |
1212 |
| Study First Received: | April 20, 2010 |
| Last Updated: | April 20, 2010 |
Keywords provided by University of Oulu:
|
phimosis, non-retractable foreskin topical steroids children |
Additional relevant MeSH terms:
|
Phimosis Penile Diseases Genital Diseases, Male Mometasone Furoate |
Anti-Inflammatory Agents Dermatologic Agents Anti-Allergic Agents |
ClinicalTrials.gov processed this record on July 14, 2017