Efficacy of topical application of zinc oxide ointment compared with zinc oxide paste and tocoferol, for treating diaper dermatitis in infant

• Conditions: Diaper dermatitis; MedDRA version: 14.1Level: PTClassification code 10012444Term: Dermatitis diaperSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2012-003567-22-IT
• Lead Sponsor: A.O. UNIVERSITARIA INTEGRATA DI VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-11
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age (between birth and 24 moths) and diaper dermatitis of grade 1 or higher.
Are the trial subjects under 18? yes
Number of subjects for this age range: 182
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Gestational age < 34 weeks, innate immunodeficiency, preexisting skin disorder (psoriasis, EBS, mycoses), patiens with persisten diaper dermatitis (> 6 weeks), corticosteroid therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of two treatments for diaper dermatitis: zinc oxide ointment and zinc oxide and tocoferol, and to evaluate the efficacy after 5 days of treatment, in infants born at 34 weeks or more of gestation.;Secondary Objective: To establish the rate of complete healing after 5 days of treatment.;Primary end point(s): One point decreasing rate score (Severity classification of diaper dermatitis), after 5 days of treatment;Timepoint(s) of evaluation of this end point: Fifth day

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Complete healing rate after 5 days of treatment.;Timepoint(s) of evaluation of this end point: Fifth day