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
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

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

ClinicalTrials.gov processed this record on August 28, 2014