Diaper RashPhase 4NCT00219466
Clinical Study to Evaluate the Efficacy and Safety of Two Marketed Investigational Products in Children With Diaper Rash
A Phase 4 study testing Zinc Oxide Diaper Rash Ointment and Aloe Vera/Tocopherol/Zinc Oxide Cream in people with Diaper Rash, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
Trial summary
To evaluate whether Desitin; Zinc Oxide Diaper Rash Ointment (Desitin Original) and Desitin Creamy; Zinc Oxide Diaper Rash Ointment (Desitin Creamy) provide relief of the signs and symptoms associated with diaper rash after 12 and 24 hours of product application. Read more about this study
- Who is it for?
- Ages 2 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Diaper Rash
- What is being tested?
- Zinc Oxide Diaper Rash Ointment and Aloe Vera/Tocopherol/Zinc Oxide Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Oct 2005
- 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 2 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male and female children, 2-36 months of age
- Wear diapers 24 hours per day
- Present to the test facility for enrollment at baseline with diaper rash receiving an "Overall Severity Score" greater than or equal to 1.5 as determined by the trained evaluator
- Parent/guardian signed informed consent
- Parent/guardian willing to use only the test product in the diaper area during the trial
- Parent/guardian willing to ensure that their child continues to wear their usual brand of diapers and will continue to clean their child during diaper changes using their usual products and method with the exception of ointments, lotions, creams or powders during the trial
- Parent/guardian is willing to refrain from changing any other products whose use may have an effect on their child's skin condition during the trial, i.e., laundry detergents, fabric softeners, and products used to bathe the child
- A Fitzpatrick Skin Type of I-IV
Who cannot join
- Illness within 4 days preceding enrollment
- Currently being toilet trained
- Active dermatological conditions other than diaper rash that may affect trial results
- History of recurrent dermatological conditions other than diaper rash that may affect trial results
- Concomitant use of medications that may affect trial results
- Known sensitivity to ingredients in trial medications
- Known sensitivity, rash or other abnormal skin reaction to topical or systemic medications or cleansing products within one year of trial initiation
- Other severe acute or chronic medical conditions that may increase the risk associated with trial participation or may interfere with the interpretation of results
Trial locations and contacts
1 site in 1 country.
United States1 site
JJCPPW Investigational Site
St. Petersburg, Florida, 33710
About this study
Official title: A Parallel, Evaluator-Blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Two Marketed Topical Skin Protectants Containing Zinc Oxide in Children With Diaper Rash
To evaluate whether Desitin; Zinc Oxide Diaper Rash Ointment (Desitin Original) and Desitin Creamy; Zinc Oxide Diaper Rash Ointment (Desitin Creamy) provide relief of the signs and symptoms associated with diaper rash after 12 and 24 hours of product application.
Read the detailed description
Subjects received applications of the investigational products following a gentle cleansing of the diaper zone at every diaper change and following bathing of the child during a 24 hour period.
Efficacy was assessed during this study through the documentation of the severity of diaper rash. Results of five anatomic areas and overall severity score by the evaluator's assessments, and parent/guardian's assessments all indicated that both products were significantly effective (P<0.05 in relieving diaper dermatitis (rash) after 12 and 24 hours of treatment.
Safety was assessed through the reporting of adverse events during the course of the study. Overall, the reporting of no adverse events under the conditions of the protocol indicate that the investigational products would appear to be safe for their intended use.
- Conditions
- Diaper Rash
- Being tested
- Zinc Oxide Diaper Rash Ointment, Aloe Vera/Tocopherol/Zinc Oxide Cream
- Medical subject headings
- Diaper Rash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc Oxide Diaper Rash OintmentOther
Also called Desitin Original, Formula 311-2
Desitin Original at diaper change
Aloe Vera/Tocopherol/Zinc Oxide CreamOther
Also called Desitin Creamy, Formula 316-1
Desitin Creamy at diaper change
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Other: Zinc Oxide Diaper Rash Ointment |
| 2 | Active comparator | Not described Receives: Other: Aloe Vera/Tocopherol/Zinc Oxide Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trained evaluator's assessment of the severity of diaper rash and Parent/guardian's assessment of response to treatment
Measured: At baseline and at 12 and 24 hours post-baseline
Secondary outcomes (1)
Adverse Events
Measured: during the course of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionOct 2005
- Study completionOct 2005
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qing Li, MD PhD, Study director, JJCPPW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219466
- Sponsor's protocol ID
- A2301007
- Status last verified
- Aug 2011
- First submitted
- 13 Sep 2005
- Last updated
- 22 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel, Evaluator-Blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Two Marketed Topical Skin Protectants Containing Zinc Oxide in Children With Diaper Rash
- ClinicalTrials.gov ID
- NCT00219466
- Acronym / sponsor ID
- A2301007
- Conditions
- Diaper Rash
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 22 Sep 2005 (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.
To evaluate whether Desitin; Zinc Oxide Diaper Rash Ointment (Desitin Original) and Desitin Creamy; Zinc Oxide Diaper Rash Ointment (Desitin Creamy) provide relief of the signs and symptoms associated with diaper rash after 12 and 24 hours of product application.
Detailed description
Subjects received applications of the investigational products following a gentle cleansing of the diaper zone at every diaper change and following bathing of the child during a 24 hour period.
Efficacy was assessed during this study through the documentation of the severity of diaper rash. Results of five anatomic areas and overall severity score by the evaluator's assessments, and parent/guardian's assessments all indicated that both products were significantly effective (P<0.05 in relieving diaper dermatitis (rash) after 12 and 24 hours of treatment.
Safety was assessed through the reporting of adverse events during the course of the study. Overall, the reporting of no adverse events under the conditions of the protocol indicate that the investigational products would appear to be safe for their intended use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Zinc Oxide Diaper Rash Ointment |
| 2 | Active comparator | Other: Aloe Vera/Tocopherol/Zinc Oxide Cream |
Who may qualify
- Ages
- 2 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Healthy male and female children, 2-36 months of age
- Wear diapers 24 hours per day
- Present to the test facility for enrollment at baseline with diaper rash receiving an "Overall Severity Score" greater than or equal to 1.5 as determined by the trained evaluator
- Parent/guardian signed informed consent
- Parent/guardian willing to use only the test product in the diaper area during the trial
Key exclusion criteria (8 listed)
- Illness within 4 days preceding enrollment
- Currently being toilet trained
- Active dermatological conditions other than diaper rash that may affect trial results
- History of recurrent dermatological conditions other than diaper rash that may affect trial results
- Concomitant use of medications that may affect trial results
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 |
|---|---|---|
| Zinc Oxide Diaper Rash OintmentAlso: Desitin Original, Formula 311-2Desitin Original at diaper change | Other | 1 |
| Aloe Vera/Tocopherol/Zinc Oxide CreamAlso: Desitin Creamy, Formula 316-1Desitin Creamy at diaper change | Other | 2 |
Primary outcome
Trained evaluator's assessment of the severity of diaper rash and Parent/guardian's assessment of response to treatment
Time frame: At baseline and at 12 and 24 hours post-baseline
1 secondary outcome
Adverse Events
Time frame: during the course of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2011.
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Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months
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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.
Qing Li, MD PhD study director
JJCPPW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zinc Oxide Diaper Rash Ointment and Aloe Vera/Tocopherol/Zinc Oxide Cream in people with Diaper Rash, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
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 8 inclusion and 8 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: finished, as of the sponsor's last update on 22 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Trained evaluator's assessment of the severity of diaper rash and Parent/guardian's assessment of response to treatment (time frame: At baseline and at 12 and 24 hours post-baseline). 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 22 Aug 2011; AzTrials last refreshed its copy on 7 Nov 2026.