search
Back to results

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

Primary Purpose

Diaper Rash

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Moussik Diaper Rash Mousse
Desitin Creamy Ointment
Sponsored by
Trima, Israel Pharmaceutical Products
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diaper Rash focused on measuring Diaper Dermatitis, Diaper Rash, Erythema

Eligibility Criteria

3 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Six point erythema skin grade
    0 - Normal skin + - Questionable erthema not covering entire area - Definite erythema - Erythema and induration - Vesiculation - Blister reaction

    Secondary Outcome Measures

    Visual analogue scale (VAS) from 0 to 10

    Full Information

    First Posted
    July 20, 2010
    Last Updated
    December 16, 2014
    Sponsor
    Trima, Israel Pharmaceutical Products
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01167465
    Brief Title
    Determination of Safety and Consumers' Satisfaction of Moussik Versus Desitin Creamy Ointment in Diaper Rash Prophylaxis
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Trima, Israel Pharmaceutical Products

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diaper Rash
    Keywords
    Diaper Dermatitis, Diaper Rash, Erythema

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    Moussik Diaper Rash Mousse
    Intervention Description
    To be used as instructed
    Intervention Type
    Other
    Intervention Name(s)
    Desitin Creamy Ointment
    Intervention Description
    To be used as instructed
    Primary Outcome Measure Information:
    Title
    Six point erythema skin grade
    Description
    0 - Normal skin + - Questionable erthema not covering entire area - Definite erythema - Erythema and induration - Vesiculation - Blister reaction
    Time Frame
    After two weeks
    Secondary Outcome Measure Information:
    Title
    Visual analogue scale (VAS) from 0 to 10
    Time Frame
    After two weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    18 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kobi Shiff, MD
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs