Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00702507
First received: June 18, 2008
Last updated: March 22, 2012
Last verified: March 2012
Results First Received: September 1, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diaper Rash
Intervention: Drug: 0.25 % Miconazole Nitrate Ointment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of 2 phases: initial treatment phase (14-day study period) and a follow-up phase (2-year study period).

Reporting Groups
  Description
Vusion Treatment Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.

Participant Flow for 2 periods

Period 1:   Initial Treatment Phase
    Vusion Treatment  
STARTED     200  
COMPLETED     159  
NOT COMPLETED     41  
Adverse Event                 2  
Participant's Caretaker Withdrew Consent                 3  
Lost to Follow-up                 2  
Negative Candida Culture                 34  

Period 2:   Follow-up Phase
    Vusion Treatment  
STARTED     159  
COMPLETED     132  
NOT COMPLETED     27  
Participant's Caretaker Withdrew Consent                 1  
Protocol Violation                 2  
Lost to Follow-up                 23  
Late Enrollment                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Vusion Treatment Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.

Baseline Measures
    Vusion Treatment  
Number of Participants  
[units: participants]
  200  
Age  
[units: Months]
Mean ± Standard Deviation
  6.6  ± 3.80  
Gender  
[units: Participants]
 
Female     112  
Male     88  
Race/Ethnicity, Customized  
[units: participants]
 
White     40  
Black     17  
Hispanic/Latino     121  
Hispanic/Persian     1  
Hispanic/White     5  
White/Black     1  
Multiracial     15  



  Outcome Measures
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1.  Primary:   Number of Participants With Overall Cure (OC)   [ Time Frame: Test-of-cure visit (Day 14) of initial treatment episode ]

2.  Secondary:   Number of Participants With Clinical Cure   [ Time Frame: Test-of-cure visit (Day 14) of initial treatment episode ]

3.  Secondary:   Number of Participants With Mycological Cure   [ Time Frame: Test-of-cure visit (Day 14) of initial treatment episode ]

4.  Secondary:   Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode   [ Time Frame: Test-of-cure visit (Day 14) of initial treatment episode ]

5.  Secondary:   Clinical Evaluations Using Change From Baseline in the Dermatitis Severity Index Score at Day 14 of the Initial Treatment Episode   [ Time Frame: Test-of-cure visit (Day 14) of initial treatment episode ]

6.  Secondary:   Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE)   [ Time Frame: Test-of-cure (TOC) visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months) ]

7.  Secondary:   Number of Participants With Clinical Cure of First to Third Recurrent Episodes   [ Time Frame: Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months) ]

8.  Secondary:   Number of Participants With Mycological Cure of First to Third Recurrent Episodes   [ Time Frame: Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months) ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00702507     History of Changes
Other Study ID Numbers: 114678, BT0100-402-USA
Study First Received: June 18, 2008
Results First Received: September 1, 2011
Last Updated: March 22, 2012
Health Authority: United States: Food and Drug Administration