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

Sponsored by Janssen Pharmaceutica

About this trial

Last updated 12 years ago

Study ID

CR015721

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18 to 60 Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 16 years ago

What is this trial about?

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).

What are the Participation Requirements?

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)