Diaper RashPhase 4NCT01167465
Determination of Safety and Consumers' Satisfaction of Moussik Versus Desitin Creamy Ointment in Diaper Rash Prophylaxis
A Phase 4 study testing Moussik Diaper Rash Mousse and Desitin Creamy Ointment in people with Diaper Rash, run by Trima, Israel Pharmaceutical Products.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Diaper Rash
- What is being tested?
- Moussik Diaper Rash Mousse and Desitin Creamy Ointment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male or female infants aged between 3-18 months who are routine users of disposable diapers
Who cannot join
- 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.
About this study
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
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.
- Conditions
- Diaper Rash
- Being tested
- Moussik Diaper Rash Mousse, Desitin Creamy Ointment
- Keywords
- Diaper Dermatitis, Diaper Rash, Erythema
- Medical subject headings
- Diaper Rash, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moussik Diaper Rash MousseOther
To be used as instructed
Desitin Creamy OintmentOther
To be used as instructed
What is being measured
The primary outcome is the main question the study is designed to answer.
Six point erythema skin grade
0 - Normal skin
+ - Questionable erthema not covering entire area
- - Definite erythema
- - Erythema and induration
- - Vesiculation
- - Blister reaction
Measured: After two weeks
Secondary outcomes (1)
Visual analogue scale (VAS) from 0 to 10
Measured: After two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaper RashStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trima, Israel Pharmaceutical Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kobi Shiff, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167465
- Sponsor's protocol ID
- Diaper Rash
- Status last verified
- Dec 2014
- First submitted
- 20 Jul 2010
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01167465
- Acronym / sponsor ID
- Diaper Rash
- Conditions
- Diaper Rash
- Keywords
- Diaper Dermatitis, Diaper Rash, Erythema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Trima, Israel Pharmaceutical ProductsIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 3 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy male or female infants aged between 3-18 months who are routine users of disposable diapers
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moussik Diaper Rash MousseTo be used as instructed | Other | – |
| Desitin Creamy OintmentTo be used as instructed | Other | – |
Primary outcome
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
1 secondary outcome
Visual analogue scale (VAS) from 0 to 10
Time frame: After two weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
Related trials for Diaper Rash
Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Diaper Dermatitis
Recruiting
Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
Not yet recruiting
Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months
Diaper Dermatitis
Recruiting
Probiotics for Diaper Dermatitis
Diaper Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kobi Shiff, MD principal investigator
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Moussik Diaper Rash Mousse and Desitin Creamy Ointment in people with Diaper Rash, run by Trima, Israel Pharmaceutical Products.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six point erythema skin grade (time frame: After two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2014.