Determination of Safety and Consumers' Satisfaction of Moussik Versus Desitin Creamy Ointment in Diaper Rash Prophylaxis
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
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2013
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2010
CompletedFirst Posted
Study publicly available on registry
July 22, 2010
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 17, 2014
December 1, 2014
11 months
July 20, 2010
December 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Six point erythema skin grade
0 - Normal skin \+ - Questionable erthema not covering entire area 1. \- Definite erythema 2. \- Erythema and induration 3. \- Vesiculation 4. \- Blister reaction
After two weeks
Secondary Outcomes (1)
Visual analogue scale (VAS) from 0 to 10
After two weeks
Interventions
To be used as instructed
To be used as instructed
Eligibility Criteria
You may qualify if:
- Healthy male or female infants aged between 3-18 months who are routine users of disposable diapers
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kobi Shiff, MD
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2010
First Posted
July 22, 2010
Study Start
January 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
December 17, 2014
Record last verified: 2014-12