An Efficacy and Safety Study of Miconazole and Hydrocortisone Cream in the Treatment of Vulvar Candidiasis
The purpose of this study is to evaluate the efficacy and safety of miconazole plus hydrocortisone cream in the treatment of participants with vulvar candidiasis (yeast infection of the vulva).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effectiveness and Safety of Daktacort Feminine Care Cream in the Treatment of Vulvar Candidiasis|
- Mean Time to Itch Relief [ Time Frame: 1-hour after initial application ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2009|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
|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.
This is an open label (all people know the identity of the intervention), single-arm, prospective (study following participants forward in time) study to evaluate the efficacy and safety of miconazole plus hydrocortisone cream in participants with vulvar candidiasis. Participants will be evaluated and assessed on the degree of pruritus (itchiness) and screened for candidiasis on the baseline. Participants will apply the cream once enrolled and will be assessed for 1-hour to get the time to relief. Each participant will apply the study medication topically (applied to skin) to the lesion twice daily up to Day 14 by rubbing gently until it has been completely penetrated into the vulvar area affected and the treatment should be continued without interruption. Participants will be followed-up after 14 days and will be assessed clinically for signs and symptoms of vulvar candidiasis; if not cured, participants will continue the medication up to Day 28. Primary efficacy endpoint will be the time needed to achieve pruritus relief. Participants' safety will be monitored throughout the study.