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 ]

Measure Type	Primary
Measure Title	Number of Participants With Overall Cure (OC)
Measure Description	OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide [KOH] and culture results). Participants who had OC were categorized as "Successes"; those without OC 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.
Modified Intent-to-Treat (MITT) Population: all participants who were dispensed study drug and had demonstrated clinical symptoms of diaper dermatitis (DD) (DD severity index score of 4-8; clinical erythema grade of >=2 [see outcome measure #4 for a description]) and confirmed Candida species (positive baseline KOH and culture for Candida species)

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 Overall Cure (OC) [units: participants]
Success	49
Failure	119

Statistical Analysis 1 for Number of Participants With Overall Cure (OC)

Groups ^[1]	Vusion Treatment
Percentage of participants ^[2]	29.2
95% Confidence Interval	( 22.4 to 36.7 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant estimation information:
	Percentage of participants with overall cure at the test-of-cure visit (Day 14) of the initial episode for participants in the MITT Population

2. Secondary:

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

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 ]

Measure Type	Secondary
Measure Title	Number of Participants With Mycological Cure
Measure Description	Participants were evaluated for mycological cure, which was defined as mycological eradication with negative KOH and culture results. Participants who had mycological cure were categorized as "Successes"; those without mycological 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 Mycological Cure [units: participants]
Success	77
Failure	91

No statistical analysis provided for Number of Participants With Mycological Cure

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 ]

Measure Type	Secondary
Measure Title	Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode
Measure Description	The diaper dermatitis severity index score was calculated as the sum of severity grades for each parameter evaluated (erythema, papules or pustules, and erosions) for the initial treatment episode. The maximum score possible for the diaper dermatitis severity index is 8. Rating scale for Erythema: 0 (none to trace), 1 (mild [pink]), 2 (moderate [red]), 3 (severe [beefy red]). Rating scale for Papules or Pustules: 0 (none to trace [0]), 1 (few [1-10]), 2 (multiple [11-20]), 3 (many [21-40]), 4 (abundant [more than 40]. Rating scale for Erosions: 0 (absent), 1 (present).
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. Participants with missing data were not included in this analysis.

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]	160
Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode [units: scores on a scale] Median ( Full Range )	0.0 ( 0 to 7 )

No statistical analysis provided for Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for 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 ]

Measure Type	Secondary
Measure Title	Clinical Evaluations Using Change From Baseline in the Dermatitis Severity Index Score at Day 14 of the Initial Treatment Episode
Measure Description	The diaper dermatitis severity index score was calculated as the sum of severity grades for each parameter evaluated (erythema, papules or pustules, and erosions). Change from baseline=baseline value minus Day 14 value. The maximum score possible for the diaper dermatitis severity index is 8. Rating scale for Erythema: 0 (none to trace), 1 (mild [pink]), 2 (moderate [red]), 3 (severe [beefy red]). Rating scale for Papules or Pustules: 0 (none to trace [0]), 1 (few [1-10]), 2 (multiple [11-20]), 3 (many [21-40]), 4 (abundant [more than 40]. Rating scale for Erosions: 0 (absent), 1 (present).
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. Participants with missing data were not included in this analysis.

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]	160
Clinical Evaluations Using Change From Baseline in the Dermatitis Severity Index Score at Day 14 of the Initial Treatment Episode [units: scores on a scale] Median ( Full Range )	-5.0 ( -8 to 1 )

No statistical analysis provided for Clinical Evaluations Using Change From Baseline in the Dermatitis Severity Index Score at Day 14 of the 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) ]

Measure Type	Secondary
Measure Title	Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE)
Measure Description	OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide and culture results) at TOC visit for initial episode (ep.) to third ep. Participants (par) who had OC were categorized as "Successes"; those without OC were categorized as "Failures" (discontinued/lost to follow-up par were also failures). A RE is not temporally associated with a prior episode (PE) irrespective of whether the PE involves continuing treatment with study medication.
Time Frame	Test-of-cure (TOC) visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)
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: only those participants with confirmed recurrence were analyzed

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]	35
Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE) [units: participants]
First Recurrence, Success; n=35	11
First Recurrence, Failure; n=35	24
Second Recurrence, Success; n=10	5
Second Recurrence, Failure; n=10	5
Third Recurrence, Success; n=4	2
Third Recurrence Failure; n=4	2

No statistical analysis provided for Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE)

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) ]

Measure Type	Secondary
Measure Title	Number of Participants With Clinical Cure of First to Third Recurrent Episodes
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 clinical 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 first to third recurrent episodes (up to approximately 1 year and 7 months)
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: only those participants with confirmed recurrence were analyzed

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]	35
Number of Participants With Clinical Cure of First to Third Recurrent Episodes [units: participants]
First Recurrence, Success; n=35	20
First Recurrence, Failure; n=35	15
Second Recurrence, Success; n=10	5
Second Recurrence, Failure; n=10	5
Third Recurrence, Success; n=4	3
Third Recurrence Failure; n=4	1

No statistical analysis provided for Number of Participants With Clinical Cure of First to Third Recurrent Episodes

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) ]

Measure Type	Secondary
Measure Title	Number of Participants With Mycological Cure of First to Third Recurrent Episodes
Measure Description	Participants were evaluated for mycological cure, which was defined as mycological eradication with negative KOH and culture results. Participants who had mycological cure were categorized as "Successes"; those without mycological 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 first to third recurrent episodes (up to approximately 1 year and 7 months)
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: only those participants with confirmed recurrence were analyzed

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]	35
Number of Participants With Mycological Cure of First to Third Recurrent Episodes [units: participants]
First Recurrence, Success; n=35	16
First Recurrence, Failure; n=35	19
Second Recurrence, Success; n=10	7
Second Recurrence, Failure; n=10	3
Third Recurrence, Success; n=4	3
Third Recurrence Failure; n=4	1

No statistical analysis provided for Number of Participants With Mycological Cure of First to Third Recurrent Episodes

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
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

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