Determination of Safety and Consumers' Satisfaction of Moussik Versus Desitin Creamy Ointment in Diaper Rash Prophylaxis

Diaper Rash Clinical Trial

Official title:

A Clinical Observation to Assess the Safety and Consumers' Satisfaction of Moussik vs Desitin Creamy Ointment in Prophylaxis of Diaper Rash. A Single Blind, Multicenter, Randomized, Cross-over Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01167465
• Other study ID #: Diaper Rash
• Status: Withdrawn
• Phase: Phase 4
• First received: July 20, 2010
• Last updated: December 16, 2014
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: Trima, Israel Pharmaceutical Products
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 18 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diaper Rash

Intervention

Other:
• Moussik Diaper Rash Mousse
To be used as instructed
• Desitin Creamy Ointment
To be used as instructed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Trima, Israel Pharmaceutical Products

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six point erythema skin grade	0 - Normal skin; + - Questionable erthema not covering entire area; - Definite erythema; - Erythema and induration; - Vesiculation; - Blister reaction	After two weeks	Yes
Secondary	Visual analogue scale (VAS) from 0 to 10		After two weeks	No