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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Oulu.
Recruitment status was  Recruiting
Sponsor:
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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

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:
  • Elocon
  • topical steroid cream
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:
  • Elocon
  • topical steroid cream
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
Genders 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
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

No publications provided

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
Health Authority: Finland: Finnish Medicines Agency

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
Emollients
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on April 17, 2014