CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 115 enrolled
Drug / intervention
Miconazole plus Hydrocortisonedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01769339
NCT01769339Phase 4Completed
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Effectiveness and Safety of Daktacort Feminine Care Cream in the Treatment of Vulvar Candidiasis

Janssen Pharmaceutica·interventional·Posted Jan 16, 2013·Updated Mar 25, 2013

In Brief

A Phase 4 clinical trial evaluating Miconazole plus Hydrocortisone for Vulva; Candidiasis. Completed, enrolled 115 participants.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulva; Candidiasis
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 16, 2013
Enrollment StartJan 1, 2009
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.5 years ago

Interventions

Miconazole plus Hydrocortisonedrug

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.