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

History of Changes

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
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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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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 ]

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2. Secondary:

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

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Measure Type	Secondary
Measure Title	Number of Participants With Clinical Cure
Measure Description	Participants were evaluated for clinical cure, which was defined as therapeutic cure with total resolution of signs and symptoms (i.e., no clinical signs of infection). Participants who had clinical cure were categorized as "Successes"; those without clianical cure were categorized as "Failures." Any discontinued or lost to follow-up participant was also considered a failure.
Time Frame	Test-of-cure visit (Day 14) of initial treatment episode
Safety Issue	No

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.
MITT Population

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 DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.

Measured Values

	Vusion Treatment
Number of Participants Analyzed [units: participants]	168
Number of Participants With Clinical Cure [units: participants]
Success	83
Failure	85

No statistical analysis provided for Number of Participants With Clinical Cure

3. Secondary:

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

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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 ]

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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 ]

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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) ]

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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) ]

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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) ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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
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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

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