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

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ClinicalTrials.gov Identifier: NCT00702507
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : October 7, 2011
Last Update Posted : March 27, 2012
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diaper Rash
Intervention Drug: 0.25 % Miconazole Nitrate Ointment
Enrollment 200
Recruitment Details  
Pre-assignment Details The study consisted of 2 phases: initial treatment phase (14-day study period) and a follow-up phase (2-year study period).
Arm/Group Title Vusion Treatment
Hide Arm/Group Description 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.
Period Title: Initial Treatment Phase
Started 200
Completed 159
Not Completed 41
Reason Not Completed
Adverse Event             2
Participant's Caretaker Withdrew Consent             3
Lost to Follow-up             2
Negative Candida Culture             34
Period Title: Follow-up Phase
Started 159
Completed 132
Not Completed 27
Reason Not Completed
Participant's Caretaker Withdrew Consent             1
Protocol Violation             2
Lost to Follow-up             23
Late Enrollment             1
Arm/Group Title Vusion Treatment
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 200
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 200 participants
6.6  (3.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants
Female
112
  56.0%
Male
88
  44.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants
White 40
Black 17
Hispanic/Latino 121
Hispanic/Persian 1
Hispanic/White 5
White/Black 1
Multiracial 15
1.Primary Outcome
Title Number of Participants With Overall Cure (OC)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Vusion Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 168
Measure Type: Number
Unit of Measure: participants
Success 49
Failure 119
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vusion Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 29.2
Confidence Interval (2-Sided) 95%
22.4 to 36.7
Estimation Comments 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 Outcome
Title Number of Participants With Clinical Cure
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Vusion Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 168
Measure Type: Number
Unit of Measure: participants
Success 83
Failure 85
3.Secondary Outcome
Title Number of Participants With Mycological Cure
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Vusion Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 168
Measure Type: Number
Unit of Measure: participants
Success 77
Failure 91
4.Secondary Outcome
Title Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population. Participants with missing data were not included in this analysis.
Arm/Group Title Vusion Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 160
Median (Full Range)
Unit of Measure: scores on a scale
0.0
(0 to 7)
5.Secondary Outcome
Title Clinical Evaluations Using Change From Baseline in the Dermatitis Severity Index Score at Day 14 of the Initial Treatment Episode
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population. Participants with missing data were not included in this analysis.
Arm/Group Title Vusion Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 160
Median (Full Range)
Unit of Measure: scores on a scale
-5.0
(-8 to 1)
6.Secondary Outcome
Title Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population: only those participants with confirmed recurrence were analyzed
Arm/Group Title Vusion Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: 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
7.Secondary Outcome
Title Number of Participants With Clinical Cure of First to Third Recurrent Episodes
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population: only those participants with confirmed recurrence were analyzed
Arm/Group Title Vusion Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: 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
8.Secondary Outcome
Title Number of Participants With Mycological Cure of First to Third Recurrent Episodes
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population: only those participants with confirmed recurrence were analyzed
Arm/Group Title Vusion Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: 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
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vusion Initial Treatment Phase Vusion Follow-up Phase
Hide Arm/Group Description 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. After the Initial Treatment Phase 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 containing 0.25 percent miconazole nitrate.
All-Cause Mortality
Vusion Initial Treatment Phase Vusion Follow-up Phase
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vusion Initial Treatment Phase Vusion Follow-up Phase
Affected / at Risk (%) Affected / at Risk (%)
Total   0/200 (0.00%)   3/168 (1.79%) 
Infections and infestations     
Staphylococcal Infection  1  0/200 (0.00%)  1/168 (0.60%) 
Pneumonia  1  0/200 (0.00%)  1/168 (0.60%) 
Nervous system disorders     
Febrile Convulsion  1  0/200 (0.00%)  1/168 (0.60%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Vusion Initial Treatment Phase Vusion Follow-up Phase
Affected / at Risk (%) Affected / at Risk (%)
Total   42/200 (21.00%)   133/168 (79.17%) 
Eye disorders     
Conjunctivitis  1  1/200 (0.50%)  12/168 (7.14%) 
Gastrointestinal disorders     
Diarrhoea  1  8/200 (4.00%)  41/168 (24.40%) 
Vomiting  1  3/200 (1.50%)  22/168 (13.10%) 
General disorders     
Pyrexia  1  18/200 (9.00%)  79/168 (47.02%) 
Infections and infestations     
Amoebiasis  1  0/200 (0.00%)  8/168 (4.76%) 
Bronchitis  1  1/200 (0.50%)  11/168 (6.55%) 
Diarrhoea infectious  1  0/200 (0.00%)  9/168 (5.36%) 
Ear infection  1  2/200 (1.00%)  11/168 (6.55%) 
Impetigo  1  2/200 (1.00%)  8/168 (4.76%) 
Influenza  1  2/200 (1.00%)  7/168 (4.17%) 
Nasopharyngitis  1  19/200 (9.50%)  69/168 (41.07%) 
Otitis media acute  1  2/200 (1.00%)  13/168 (7.74%) 
Pharyngitis  1  0/200 (0.00%)  12/168 (7.14%) 
Pharyngotonsilitis  1  0/200 (0.00%)  15/168 (8.93%) 
Respiratory tract infection  1  0/200 (0.00%)  10/168 (5.95%) 
Rhinitis  1  2/200 (1.00%)  14/168 (8.33%) 
Tonsillitis  1  1/200 (0.50%)  28/168 (16.67%) 
Varicella  1  0/200 (0.00%)  6/168 (3.57%) 
Viral infection  1  1/200 (0.50%)  10/168 (5.95%) 
Viral rash  1  3/200 (1.50%)  7/168 (4.17%) 
Injury, poisoning and procedural complications     
Arthropod bite  1  0/200 (0.00%)  6/168 (3.57%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/200 (0.50%)  16/168 (9.52%) 
Cough  1  1/200 (0.50%)  26/168 (15.48%) 
Rhinitis allergic  1  0/200 (0.00%)  6/168 (3.57%) 
Skin and subcutaneous tissue disorders     
Dermatitis diaper  1  0/200 (0.00%)  23/168 (13.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00702507     History of Changes
Other Study ID Numbers: 114678
BT0100-402-USA ( Other Identifier: Barrier Therapeutics )
First Submitted: June 18, 2008
First Posted: June 20, 2008
Results First Submitted: September 1, 2011
Results First Posted: October 7, 2011
Last Update Posted: March 27, 2012