Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study

April 20, 2010 updated by: University of Oulu

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland, 90029
        • Recruiting
        • Oulu University Hospital, Department of Children and Adolescents
        • Contact:
        • Principal Investigator:
          • Johanna Rättyä, M.D, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • non-retractable foreskin requiring treatment

Exclusion Criteria:

  • age under six years old, previous operation or steroid treatment for phimosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Elocon
  • topical steroid cream
Drug: moisturizing cream
study cream was applicated once per day for 4 to 8 weeks
Other Names:
  • Novalan
Placebo Comparator: moisturizer
Drug: Mometasone furoate cream
Study cream was applicated once per day for 4-8 weeks.
Other Names:
  • Elocon
  • topical steroid cream
Drug: moisturizing cream
study cream was applicated once per day for 4 to 8 weeks
Other Names:
  • Novalan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retractability of foreskin
Time Frame: 4-16 weeks
4-16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

April 20, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (Estimate)

April 21, 2010

Study Record Updates

Last Update Posted (Estimate)

April 21, 2010

Last Update Submitted That Met QC Criteria

April 20, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1212 (Copenhagen University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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