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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01167465
Recruitment Status : Withdrawn
First Posted : July 22, 2010
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diaper Rash Other: Moussik Diaper Rash Mousse Other: Desitin Creamy Ointment Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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
Study Start Date : January 2013
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Six point erythema skin grade [ Time Frame: 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 :
  1. Visual analogue scale (VAS) from 0 to 10 [ Time Frame: After two weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167465


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

Responsible Party: Trima, Israel Pharmaceutical Products
ClinicalTrials.gov Identifier: NCT01167465     History of Changes
Other Study ID Numbers: Diaper Rash
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: December 2014

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

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