An Efficacy and Safety Study of Miconazole and Hydrocortisone Cream in the Treatment of Vulvar Candidiasis
|ClinicalTrials.gov Identifier: NCT01769339|
Recruitment Status : Completed
First Posted : January 16, 2013
Results First Posted : March 25, 2013
Last Update Posted : March 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Vulva; Candidiasis||Drug: Miconazole plus Hydrocortisone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness and Safety of Daktacort Feminine Care Cream in the Treatment of Vulvar Candidiasis|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
|Experimental: Miconazole plus Hydrocortisone||
Drug: Miconazole plus Hydrocortisone
Participants will apply miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14 by rubbing gently until it has been completely penetrated into the affected vulvar (the tissues around the opening to the vagina) area and the treatment should be continued without interruption. Participants will be assessed for signs and symptoms of vulvar candidiasis at Day 14. Medication will be continued till Day 28, if signs and symptoms of vulvar candidiasis are not cured clinically on Day 14.
- Mean Time to Itch Relief [ Time Frame: 1-hour after initial application ]Time to itch relief is defined as time needed to achieve pruritus (itchiness) relief.
- Percentage of Participants Who Achieved Clinical Cure [ Time Frame: Baseline up to Day 28 ]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.
- Modified Itch Severity Scale (MISS) Score [ Time Frame: Baseline and Day 28 ]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.
- Pruritus Symptom Assessment by Visual Analog Scale (VAS) Score [ Time Frame: 1-hour after initial application ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769339
|Study Director:||Janssen Pharmaceutica Clinical Trial||Janssen Pharmaceutica|