Phase 4
N=115
An Efficacy and Safety Study of Miconazole and Hydrocortisone Cream in the Treatment of Vulvar Candidiasis
Vulva; Candidiasis
Bottom Line
View on ClinicalTrials.gov: NCT01769339 ↗Enrolled (actual)
115
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Mean Time to Itch Relief — 13.36 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Miconazole plus Hydrocortisone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Janssen Pharmaceutica
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Time to Itch Relief |
13.36 | — |
| SECONDARY Percentage of Participants Who Achieved Clinical Cure |
97.30 | — |
| SECONDARY Modified Itch Severity Scale (MISS) Score |
7.25; 4.27 | <0.0001 sig |
| SECONDARY Pruritus Symptom Assessment by Visual Analog Scale (VAS) Score |
— | — |
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).
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01769339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.