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

Phase 4

Completed

• Conditions: Vulva; Candidiasis
• Interventions: Drug: Miconazole plus Hydrocortisone

• Registration Number: NCT01769339
• Lead Sponsor: Janssen Pharmaceutica

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2013-01-14
• Study First Submitted QC: 2013-01-14
• Study First Posted: 2013-01-16
• Status Verified: 2013-02
• Results First Submitted: 2013-02-18
• Results First Submitted QC: 2013-02-18
• Last Update Submitted: 2013-02-18
• Results First Posted: 2013-03-25
• Last Update Posted: 2013-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 115

Inclusion Criteria

• Positive potassium hydroxide (KOH) mount / Gram stain (a method used to diagnose bacterial infection) of vulvar (the tissues around the opening to the vagina) scrapings - Vulvar candidiasis with at least mild pruritus

Exclusion Criteria

• Participants with vaginal candidiasis (yeast infection of the vagina) - History of allergy to miconazone (an antifungal agent, is used for skin infections such as vaginal yeast infections) and/or other components of the study drug - Pruritus caused by etiologic (the cause) agents aside from fungi - Tuberculous (bacterial infection that usually results in a serious lung disorder) skin infection - Herpes simplex (viral infection), vaccinia (vaccine used to eradicate smallpox), all forms of varicella (infection caused by the varicella-zoster virus), and vulvar malignancy (cancer)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Miconazole plus Hydrocortisone	Miconazole plus Hydrocortisone	-

Primary Outcome Measures

Name	Time	Method
Mean Time to Itch Relief	1-hour after initial application	Time to itch relief is defined as time needed to achieve pruritus (itchiness) relief.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Clinical Cure	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	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	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.