Efficacy of Salovito nappy cream on treatment of diaper dermatitis
Phase 3
- Conditions
- Diaper Dermatitis in Children.Diaper dermatitis
- Registration Number
- IRCT20190228042868N2
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 184
Inclusion Criteria
Children under 2 years of age
Presence of diaper dermatitis
Informed consent from parents to participate in the study
Exclusion Criteria
Children with severe diarrhea
Use of corticosteroid medication on the area affected by diaper dermatitis within the past 5 days
Very severe diaper dermatitis (grade 5 to 6 based on the NIPS tool)
Accompanying severe infectious diseases
Lack of informed consent from parents to participate in the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The severity of inflammation and redness of diaper dermatitis. Timepoint: Physical examination of the child on days zero, three, five, and seven of study entry. Method of measurement: Grading of the Diaper Dermatitis Severity Index: In this grading system, the severity of inflammation in the diaper area will be examined in four categories, including: 1. Severity of redness and irritation of the skin area (score between 0 to 3). 2. Extent of spread of diaper dermatitis (score between 0 to 1). 3. Presence of papules or pustules in the inflamed area (score between 0 to 1). 4. Presence of open sores (score between 0 to 1). Finally, the scores from these four sections will be summed to obtain an overall score for comparing the severity and involvement of diaper dermatitis.
- Secondary Outcome Measures
Name Time Method