Diaper Dermatitis in Children. Diaper dermatitis
Conditions
Interventions
Intervention 1: Intervention group: In this group, the SALOVITO brand diaper rash cream for infants under one year will be used (Product ID: 413000303 and Health License Number: 2648/?/56). The active
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
No minimum to 2 Years
Inclusion criteria
Inclusion criteria: Children under 2 years of age Presence of diaper dermatitis Informed consent from parents to participate in the study
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The severity of pain caused by diaper dermatitis. Timepoint: Physical examination of the child on days zero, three, five, and seven of study entry. Method of measurement: To assess and measure the pain caused by diaper dermatitis, the Neonatal Infant Pain Scale (NIPS) will be used. In this tool, various factors including facial expression, crying pattern, breathing pattern, arm movements, leg movements, and state of arousal are examined. The severity of the child's/infant's pain is categorized from grade 0 (no pain) to grade 6 (severe pain).;Presence of symptoms of itching and burning in the child. Timepoint: Physical examination of the child on days zero, three, five, and seven of study entry. Method of measurement: Yes/No.;Potential side effects from the use of Salovito (case group) and Calandola (control group) creams. Timepoint: Physical examination of the child on days zero, three, five, and seven of study entry. Method of measurement: None / Name of side effect (skin irritation, allergic reactions, dryness or flaking, contact dermatitis, infection, photosensitivity, skin discoloration, or systemic effects). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Kazemian
Shahid Beheshti University of Medical Sciences
Outcome results
None listed