Dermatological use test in the diaper area with Protective Balm WO 3396 on babies and toddlers

Not Applicable

• Conditions: Diaper rash; L22; Diaper [napkin] dermatitis

• Registration Number: DRKS00009503
• Lead Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2013-06-04
• Study Start: 2015-10-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Wearing of disposable diapers,
Regular users of protective balm/cream

Exclusion Criteria

Documented allergies to cosmetic products,
active skin dieseases at test area,
not using diaper during the day and night,
application of other skin care products at the test area, participation in similar cosmetic and/or pharmaceutical studies

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tolerability: assessment of objective skin parameters by a pediatrician at the beginning and after 4 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Cosmetic acceptance: evaluation of product properties after the study (parents' questionnaire)