Status:
COMPLETED
Clinical Study to Evaluate the Efficacy and Safety of Two Marketed Investigational Products in Children With Diaper Rash
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Diaper Rash
Eligibility:
All Genders
2-36 years
Phase:
PHASE4
Brief 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...
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. Effic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00219466
Start Date
June 1 2005
End Date
October 1 2005
Last Update
August 22 2011
Active Locations (1)
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1
JJCPPW Investigational Site
St. Petersburg, Florida, United States, 33710