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CompletedNCT00219466Updated Aug 22, 2011

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

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

Phase
Phase 4
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
2 Months to 36 Months
Sex
All
01

Study 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 with diaper rash after 12 and 24 hours of product application.

Read the 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.

02

Conditions studied

  • Diaper Rash

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03

In context

Diaper Rash

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
2 Months to 36 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
112 participants (actual)

Study arms

  • Active comparator
    1

    Other: Zinc Oxide Diaper Rash Ointment

  • Active comparator
    2

    Other: Aloe Vera/Tocopherol/Zinc Oxide Cream

Interventions

  • OtherZinc Oxide Diaper Rash Ointment

    Desitin Original at diaper change

    Also known as: Desitin Original, Formula 311-2

  • OtherAloe Vera/Tocopherol/Zinc Oxide Cream

    Desitin Creamy at diaper change

    Also known as: Desitin Creamy, Formula 316-1

06

What researchers measure

Primary outcomes

  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

Secondary outcomes

  1. Adverse Events

    Time frame: during the course of the study

07

Study locations

1 site
  • JJCPPW Investigational Site
    St. Petersburg, Florida 33710, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00219466
Lead sponsor
Johnson & Johnson Consumer and Personal Products Worldwide
Responsible party
Sponsor
First posted
Sep 22, 2005
Start date
Jun 2005
Primary completion
Oct 2005
Completion
Oct 2005
Last update
Aug 22, 2011

Study contacts

Qing Li, MD PhD
study director · JJCPPW

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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