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

PHASE4CompletedINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

June 30, 2009

Study Completion Date

June 30, 2009

Conditions
Vulva; Candidiasis
Interventions
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.

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutica

INDUSTRY

NCT01769339 - An Efficacy and Safety Study of Miconazole and Hydrocortisone Cream in the Treatment of Vulvar Candidiasis | Biotech Hunter | Biotech Hunter