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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00219466
First received: September 13, 2005
Last updated: August 19, 2011
Last verified: August 2011

September 13, 2005
August 19, 2011
June 2005
October 2005   (final data collection date for 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 ] [ Designated as safety issue: No ]
Trained evaluator's assessment of the severity of diaper rash Parent/guardian's assessment of response to treatment
Complete list of historical versions of study NCT00219466 on ClinicalTrials.gov Archive Site
Adverse Events [ Time Frame: during the course of the study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Clinical Study to Evaluate the Efficacy and Safety of Two Marketed Investigational Products in Children With Diaper Rash
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Diaper Rash
  • Other: Zinc Oxide Diaper Rash Ointment
    Desitin Original at diaper change
    Other Name: Desitin Original, Formula 311-2
  • Other: Aloe Vera/Tocopherol/Zinc Oxide Cream
    Desitin Creamy at diaper change
    Other Name: Desitin Creamy, Formula 316-1
  • Active Comparator: 1
    Intervention: Other: Zinc Oxide Diaper Rash Ointment
  • Active Comparator: 2
    Intervention: Other: Aloe Vera/Tocopherol/Zinc Oxide Cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
October 2005
October 2005   (final data collection date for primary outcome measure)

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
Both
2 Months to 36 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00219466
A2301007
No
Johnson & Johnson Consumer and Personal Products Worldwide
Johnson & Johnson Consumer and Personal Products Worldwide
Not Provided
Study Director: Qing Li, MD PhD JJCPPW
Johnson & Johnson Consumer and Personal Products Worldwide
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP