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Withdrawn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

Study Timeline

• Study First Submitted: 2010-07-20
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-22
• Study Start: 2013-01
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-17

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• Status: WITHDRAWN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