A Phase 4 interventional study of Zinc Oxide Diaper Rash Ointment and Aloe Vera/Tocopherol/Zinc Oxide Cream in Diaper Rash, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide. Completed at 1 site in United States. Open to participants aged 2 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-22.
Sponsored by Johnson & Johnson Consumer and Personal Products Worldwide · Phase 4, Interventional, and Treatment
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.
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.
38 studies on the registry are indexed under Diaper Rash; 4 are open to participants now.
This study's enrollment of 112 is above the median of 98 across 28 interventional studies indexed under Diaper Rash.
Browse Diaper Rash studies →Johnson & Johnson Consumer and Personal Products Worldwide is the lead sponsor of 58 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Zinc Oxide Diaper Rash Ointment
Other: Aloe Vera/Tocopherol/Zinc Oxide Cream
Desitin Original at diaper change
Also known as: Desitin Original, Formula 311-2
Desitin Creamy at diaper change
Also known as: Desitin Creamy, Formula 316-1
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
Adverse Events
Time frame: during the course of the study
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Consumer and Personal Products Worldwide