Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Efficacy and Safety Study of Miconazole and Hydrocortisone Cream in the Treatment of Vulvar Candidiasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01769339
Recruitment Status : Completed
First Posted : January 16, 2013
Results First Posted : March 25, 2013
Last Update Posted : March 25, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Vulva; Candidiasis
Intervention Drug: Miconazole plus Hydrocortisone
Enrollment 115
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Miconazole Plus Hydrocortisone
Hide Arm/Group Description Participants applied miconazole plus hydrocortisone cream topically (applied to skin) to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis (yeast infection of the vulva) were not cured clinically on Day 14.
Period Title: Overall Study
Started 115
Completed 72
Not Completed 43
Reason Not Completed
Lost to Follow-up             42
Adverse Event             1
Arm/Group Title Miconazole Plus Hydrocortisone
Hide Arm/Group Description Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
Overall Number of Baseline Participants 115
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 115 participants
37.76  (9.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants
Female
115
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Mean Time to Itch Relief
Hide Description Time to itch relief is defined as time needed to achieve pruritus (itchiness) relief.
Time Frame 1-hour after initial application
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all the participants who received at least 1 dose of study medication.
Arm/Group Title Miconazole Plus Hydrocortisone
Hide Arm/Group Description:
Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
Overall Number of Participants Analyzed 115
Mean (Standard Error)
Unit of Measure: minutes
13.36  (1.41)
2.Secondary Outcome
Title Percentage of Participants Who Achieved Clinical Cure
Hide Description Participants were considered as clinically cured if the potassium hydroxide (KOH) mount / Gram stain (a method used to diagnose bacterial infection) test was negative for infection.
Time Frame Baseline up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all the participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Miconazole Plus Hydrocortisone
Hide Arm/Group Description:
Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
Overall Number of Participants Analyzed 74
Measure Type: Number
Unit of Measure: percentage of participants
97.30
3.Secondary Outcome
Title Modified Itch Severity Scale (MISS) Score
Hide Description The MISS is a specific instrument for assessing and quantifying the intensity of pruritus. The MISS score ranges from 0 to 21, where 0=no itching and 21=very severe itching.
Time Frame Baseline and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population included all the participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants who were evaluable at specified time-point.
Arm/Group Title Miconazole Plus Hydrocortisone
Hide Arm/Group Description:
Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=115) 7.25  (2.57)
Day 28 (n=7) 4.27  (0.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Miconazole Plus Hydrocortisone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Pruritus Symptom Assessment by Visual Analog Scale (VAS) Score
Hide Description Pruritus is assessed by using a 100 millimeter (mm) of VAS score ranges from 0 to 100 mm, where 0 mm=no pruritus and 100 mm=worse pruritus.
Time Frame 1-hour after initial application
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected as only few participants had pruritus after 1-hour of study drug application.
Arm/Group Title Miconazole Plus Hydrocortisone
Hide Arm/Group Description:
Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From signing of informed consent until 30 days after the last dose of study medication
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Miconazole Plus Hydrocortisone
Hide Arm/Group Description Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
All-Cause Mortality
Miconazole Plus Hydrocortisone
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Miconazole Plus Hydrocortisone
Affected / at Risk (%)
Total   0/115 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Miconazole Plus Hydrocortisone
Affected / at Risk (%)
Total   2/115 (1.74%) 
Skin and subcutaneous tissue disorders   
Pruritus * 1  2/115 (1.74%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
Data was not collected for pruritus symptom assessment by visual analog scale outcome measure as only few participants had pruritus after 1-hour of study drug application.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Affairs Manager
Organization: Janssen Philippines
Phone: +6328248935
Layout table for additonal information
Responsible Party: Janssen Pharmaceutica
ClinicalTrials.gov Identifier: NCT01769339     History of Changes
Other Study ID Numbers: CR015721
MICFUN4001
First Submitted: January 14, 2013
First Posted: January 16, 2013
Results First Submitted: February 18, 2013
Results First Posted: March 25, 2013
Last Update Posted: March 25, 2013