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

This study is not yet open for participant recruitment.
Verified March 2012 by Trima, Israel Pharmaceutical Products
Sponsor:
Information provided by (Responsible Party):
Trima, Israel Pharmaceutical Products
ClinicalTrials.gov Identifier:
NCT01167465
First received: July 20, 2010
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

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:

MedlinePlus related topics: Rashes
Drug Information available for: Zinc oxide
U.S. FDA Resources

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 ]

Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated 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
  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167465

Contacts
Contact: Kobi Shiff, MD 972-9-8604662 kobishiff@walla.com

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

No publications provided

Responsible Party: Trima, Israel Pharmaceutical Products
ClinicalTrials.gov Identifier: NCT01167465     History of Changes
Other Study ID Numbers: Diaper Rash
Study First Received: July 20, 2010
Last Updated: March 20, 2012
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Dermatitis, Contact
Diaper Rash
Exanthema
Dermatitis, Irritant
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Zinc Oxide
 Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013