Efficacy of Topical Salovito Nappy Cream on Treatment of Diaper Dermatitis in Children: A Double-Blinded Randomized Controlled Trial

Evaluating the Efficacy of Salovito Diaper Rash Cream for Infants Under One Year in Treating Diaper Dermatitis in Children

This study will be conducted as a double-blind clinical trial. The doctors and nurses conducting the study will be blind to the group assignments, and the mothers and caregivers of the infants will also be unaware of the type of cream received

Demographic information and baseline status of diaper dermatitis will be recorded on day zero (the first day of study entry). Then, a package of ointment containing only a code will be provided to the mother (or her nurse). Both the intervention and control groups will receive the ointment in identical containers with the same instructions. The patient will be clinically evaluated twice daily until complete recovery. The status of diaper dermatitis, including its extent, severity, and grade, will be collected on days three, five, and seven. All data will be collected through interviews, clinical evaluations, and photographs for skin assessment.

Inclusion criteria for the study will include children under 2 years of age. Children with severe diarrhea, use of topical corticosteroids within the past 5 days, very severe diaper dermatitis (grade 5 or 6), or severe accompanying infectious diseases will be excluded from the study

All children and infants will be randomly assigned in a pre-determined stratified 1:1 ratio to receive either the Salovito diaper rash cream for infants under one year (intervention group) or the Canola cream (control group)

The primary outcome variable is the severity of inflammation and redness of diaper dermatitis. Secondary outcome variables include the severity of pain caused by diaper dermatitis, the presence of itching and burning symptoms, and potential side effects.

Infants will be randomly assigned in a 1:1 ratio to either the case group or the control group using a computer-generated block randomization sequence with variable block sizes. To ensure allocation concealment, the assignments will be managed by a third party, who will determine the allocation by phone call upon the enrollment of each new patient. This trial will be conducted as a double-blinded randomized controlled trial, meaning that both the patients and all healthcare providers involved in the study, including doctors, nurses, and staff, will be blinded to the group assignments.

This trial will be conducted as a double-blinded randomized controlled trial, meaning that both the patients and all healthcare providers involved in the study, including doctors, nurses, and staff, will be blinded to the group assignments. The Salovito (case) and Calandola (control) creams will be packaged in similar boxes with the same color and shape and will be numbered. According to the allocation report, patients will be randomly assigned in a 1:1 ratio to the case and control groups.

All files and documents can be shared after making them unidentifiable.

One month after the publication of the results, the files will be available.

All academic researchers and other scientific and industrial centers can be informed about the data.

This data can be helpful in similar investigations.

The applicant can send her/his request to the e-mail address or call the announced phone numbers

After determining the required items, the required items will be sent within a few working days (less than a week).