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

Condition(s) targeted: Vulva; Candidiasis

Intervention: Miconazole plus Hydrocortisone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Janssen Pharmaceutica

Official(s) and/or principal investigator(s):
Janssen Pharmaceutica Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutica

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).

Official title: Effectiveness and Safety of Daktacort Feminine Care Cream in the Treatment of Vulvar Candidiasis

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Mean Time to Itch Relief

Secondary outcome:

Percentage of Participants Who Achieved Clinical Cure

Modified Itch Severity Scale (MISS) Score

Pruritus Symptom Assessment by Visual Analog Scale (VAS) Score

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.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Female.

Criteria:

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)

Starting date: January 2009
Last updated: February 18, 2013