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

University of Oulu

Status and phase: Unknown; Phase 4

Conditions: Phimosis

Treatments: Drug: Mometasone furoate cream; Drug: moisturizing cream

Study type: Interventional

Funder types: Other

Identifiers

NCT01108198

1212

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• non-retractable foreskin requiring treatment

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

mometasone furoate cream

Active Comparator group

Description:

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

Treatment:

Drug: moisturizing cream

Drug: Mometasone furoate cream

moisturizer

Placebo Comparator group

Treatment:

Drug: moisturizing cream

Drug: Mometasone furoate cream