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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00009503
Enrollment
32
Registered
2015-10-16
Start date
2013-05-07
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Diaper rash L22

Interventions

Group 1: Protective Balm WO 3396, topical application, ad libitum, for 4 weeks

Sponsors

Dr. August Wolff GmbH & Co. KG Arzneimittel
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 30 Months

Inclusion criteria

Inclusion criteria: Wearing of disposable diapers, Regular users of protective balm/cream

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Tolerability: assessment of objective skin parameters by a pediatrician at the beginning and after 4 weeks of treatment

Secondary

MeasureTime frame
Cosmetic acceptance: evaluation of product properties after the study (parents' questionnaire)

Countries

Germany

Contacts

Public ContactStephan Bielfeldt

proDERM Institut für AngewandteDermatologische Forschung GmbH

SBielfeldt@proDERM.de040-839 358 52

Outcome results

None listed

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