NCT01108198

Brief 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 study.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Last Updated

April 21, 2010

Status Verified

April 1, 2010

Enrollment Period

4.7 years

First QC Date

April 20, 2010

Last Update Submit

April 20, 2010

Conditions

Phimosis

Keywords

phimosis,non-retractable foreskintopical steroidschildren

Outcome Measures

Primary Outcomes (1)

  • Retractability of foreskin

    4-16 weeks

Study Arms (2)

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

Drug: Mometasone furoate creamDrug: moisturizing cream

moisturizer

PLACEBO COMPARATOR
Drug: Mometasone furoate creamDrug: moisturizing cream

Interventions

Mometasone furoate creamDRUG

Study cream was applicated once per day for 4-8 weeks.

Also known as: Elocon, topical steroid cream
moisturizermometasone furoate cream
moisturizing creamDRUG

study cream was applicated once per day for 4 to 8 weeks

Also known as: Novalan
moisturizermometasone furoate cream

Eligibility Criteria

Age6 Years - 16 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • non-retractable foreskin requiring treatment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital, Department of Children and Adolescents

Oulu, 90029, Finland

RECRUITING

MeSH Terms

Conditions

Phimosis

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Penile DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Johanna Rättyä, M.D., Ph.D

CONTACT

+358 8 315 2011johanna.rattya@ppshp.fi

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2010

First Posted

April 21, 2010

Study Start

October 1, 2006

Primary Completion

June 1, 2011

Last Updated

April 21, 2010

Record last verified: 2010-04

Locations

FI(1)