Diaper Rash
Conditions
Interventions
This is a 5-week, open-label, non-randomized, single-arm, comparative pilot clinical trial. Approximately 55 infants aged 6 to 12 months who meet the eligibility criteria will be enrolled. All infants
E07.325.068.249
Sponsors
Kimberly-Clark Brasil Industria e Comercio De Produtos De Higiene Ltda
Kimberly-Clark Brasil Industria e Comercio De Produtos De Higiene Ltda
Eligibility
Age
6 Months to 12 Months
Inclusion criteria
Inclusion criteria: Infants from 6 to 12 months old; both sexes; in good general health; free from diaper rash or presenting a mild to moderate diaper rash; legal guardians are more than 18 years old and have signed the informed consent form
Exclusion criteria
Exclusion criteria: Subjects who present any allergy and sensitivity to products of the same category of the investigational products; present any history and skin condition that may compromise the study results or the subject’s safety; and have used oral and/or topical antibiotics, antifungals, antihistamines and/or corticosteroids in the 2 weeks prior to enrollment visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to evaluate the diaper rash incidence during the use of the investigational diaper change regimen compared to usual diaper change products of study subjects through diaper rash occurrence during each regimen | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to evaluate the presence of diaper rash after each regimen, usual and investigational through clinical evaluation of diaper rash identified during each regimen;It is expected to evaluate the difference on skin parameters (trans epidermal water loss, hydration and pH) before and after use of the investigational regimen through the average values ??of each biophysical measurement | — |
Countries
Brazil
Contacts
Public ContactJéssica Pereira
Kimberly-Clark Brasil Industria e Comercio De Produtos De Higiene Ltda
Outcome results
None listed