Determination of Safety and Consumers' Satisfaction of Moussik Versus Desitin Creamy Ointment in Diaper Rash Prophylaxis
Phase 4
Withdrawn
- Conditions
- Diaper Rash
- Registration Number
- NCT01167465
- Lead Sponsor
- Trima, Israel Pharmaceutical Products
- Brief Summary
The purpose of this clinical observation is to evaluate the safety and consumers' satisfaction of Moussik vs Desitin Creamy ointment as a diaper rash protection product.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Healthy male or female infants aged between 3-18 months who are routine users of disposable diapers
Exclusion Criteria
- Children with symptoms of systemic disease or skin lesions.
- Children diagnosed as having diaper dermatitis at baseline
- Known hypersensitivity to any of the components of the trial preparations.
- Children suffering from atopic diseases.
- Children who have participated during the last month in another clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Six point erythema skin grade After two weeks 0 - Normal skin
+ - Questionable erthema not covering entire area
1. - Definite erythema
2. - Erythema and induration
3. - Vesiculation
4. - Blister reaction
- Secondary Outcome Measures
Name Time Method Visual analogue scale (VAS) from 0 to 10 After two weeks