Clinical Study to Evaluate the Efficacy and Safety of Two Marketed Investigational Products in Children With Diaper Rash

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 4

Conditions

Diaper Rash

Treatments

Other: Aloe Vera/Tocopherol/Zinc Oxide Cream

Other: Zinc Oxide Diaper Rash Ointment

Study type

Interventional

Funder types

Industry

Identifiers

NCT00219466

A2301007

Details and patient eligibility

About

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.

Full 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.

Enrollment

112 patients

Sex

All

Ages

2 to 36 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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