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

Efficacy of topical application of zinc oxide ointment compared with zinc oxide paste and tocoferol, for treating diaper dermatitis in infant: a randomized, controlled, triple blind study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-003567-22-IT
Enrollment
Unknown
Registered
2012-12-11
Start date
2012-12-05
Completion date
Unknown
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaper dermatitis MedDRA version: 14.1 Level: PT Classification code 10012444 Term: Dermatitis diaper System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: ZINCO OSSIDO UNG 30G 4202 Pharmaceutical Form: Ointment INN or Proposed INN: ZINC OXIDE CAS Number: 1314-13-2 Concentration unit: % percent Concentration type: equal Concentration number:

Sponsors

A.O. UNIVERSITARIA INTEGRATA DI VERONA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Gestational age 6 weeks), corticosteroid therapy

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary end point(s): Complete healing rate after 5 days of treatment.;Timepoint(s) of evaluation of this end point: Fifth day—

Countries

Italy

Contacts

Public ContactPediatria d.O.

Azienda Ospedaliera Universitaria Integrata Verona

amabile.bonaldi@ospedaleuniverona.it0458122729

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026