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

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Trima, Israel Pharmaceutical Products Identifier:
First received: July 20, 2010
Last updated: December 16, 2014
Last verified: December 2014
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.

Condition Intervention Phase
Diaper Rash
Other: Moussik Diaper Rash Mousse
Other: Desitin Creamy Ointment
Phase 4

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

Resource links provided by NLM:

Further study details as provided by Trima, Israel Pharmaceutical Products:

Primary Outcome Measures:
  • Six point erythema skin grade [ Time Frame: After two weeks ] [ Designated as safety issue: Yes ]

    0 - Normal skin

    + - Questionable erthema not covering entire area

    1. - Definite erythema
    2. - Erythema and induration
    3. - Vesiculation
    4. - Blister reaction

Secondary Outcome Measures:
  • Visual analogue scale (VAS) from 0 to 10 [ Time Frame: After two weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Moussik Diaper Rash Mousse
    To be used as instructed
    Other: Desitin Creamy Ointment
    To be used as instructed

Ages Eligible for Study:   3 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT01167465

Sponsors and Collaborators
Trima, Israel Pharmaceutical Products
Principal Investigator: Kobi Shiff, MD
  More Information

No publications provided

Responsible Party: Trima, Israel Pharmaceutical Products Identifier: NCT01167465     History of Changes
Other Study ID Numbers: Diaper Rash
Study First Received: July 20, 2010
Last Updated: December 16, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Trima, Israel Pharmaceutical Products:
Diaper Dermatitis
Diaper Rash

Additional relevant MeSH terms:
Diaper Rash
Dermatitis, Contact
Dermatitis, Irritant
Skin Diseases
Skin Diseases, Eczematous
Zinc Oxide
Dermatologic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Sunscreening Agents
Therapeutic Uses processed this record on November 24, 2015