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
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 16 years ago
What is this trial about?
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)