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
  Purpose

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.


Condition Intervention Phase
Diaper Rash
Other: Zinc Oxide Diaper Rash Ointment
Other: Aloe Vera/Tocopherol/Zinc Oxide Cream
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: during the course of the study ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: June 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Other: Zinc Oxide Diaper Rash Ointment
Desitin Original at diaper change
Other Name: Desitin Original, Formula 311-2
Active Comparator: 2 Other: Aloe Vera/Tocopherol/Zinc Oxide Cream
Desitin Creamy at diaper change
Other Name: Desitin Creamy, Formula 316-1

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.

  Eligibility

Ages Eligible for Study:   2 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219466

Locations
United States, Florida
JJCPPW Investigational Site
St. Petersburg, Florida, United States, 33710
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Study Director: Qing Li, MD PhD JJCPPW
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00219466     History of Changes
Other Study ID Numbers: A2301007
Study First Received: September 13, 2005
Last Updated: August 19, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diaper Rash
Dermatitis, Irritant
Dermatitis, Contact
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Zinc
Zinc Oxide
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Sunscreening Agents
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on September 16, 2014