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

December 16, 2014 updated by: Trima, Israel Pharmaceutical Products

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After two weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual analogue scale (VAS) from 0 to 10
Time Frame: After two weeks
After two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trima, Israel Pharmaceutical Products

Investigators

  • Principal Investigator: Kobi Shiff, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

July 20, 2010

First Submitted That Met QC Criteria

July 21, 2010

First Posted (ESTIMATE)

July 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diaper Rash

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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