NCT01769339

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Janssen Pharmaceutica · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vulva; Candidiasis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2013-01-16
• Last updated: 2013-03-25
• Results posted: 2013-03-25