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

NCT01769339 | Completed Phase 4 Results

• 2 other identifiers: CR015721MICFUN4001
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Vulva; Candidiasis

Keywords

Vulvar Candidiasis; Miconazole; Hydrocortisone; Daktacort Feminine Care Cream

Outcome Measures

Primary Outcomes (1)

• Mean Time to Itch Relief

  Time to itch relief is defined as time needed to achieve pruritus (itchiness) relief.

  1-hour after initial application

Secondary Outcomes (3)

• Percentage of Participants Who Achieved Clinical Cure

  Baseline up to Day 28

• Modified Itch Severity Scale (MISS) Score

  Baseline and Day 28

• Pruritus Symptom Assessment by Visual Analog Scale (VAS) Score

  1-hour after initial application

Study Arms (1)

Miconazole plus Hydrocortisone

EXPERIMENTAL

Drug: Miconazole plus Hydrocortisone

Interventions

Miconazole plus Hydrocortisone DRUG

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.

Miconazole plus Hydrocortisone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Janssen Pharmaceutica: lead

MeSH Terms

Conditions

Candidiasis

Interventions

Miconazole; Hydrocortisone

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Limitations and Caveats

Data was not collected for pruritus symptom assessment by visual analog scale outcome measure as only few participants had pruritus after 1-hour of study drug application.

Results Point of Contact

• Title: Medical Affairs Manager
• Organization: Janssen Philippines

+6328248935

Study Officials

• Janssen Pharmaceutica Clinical Trial

  Janssen Pharmaceutica

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 16, 2013
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 25, 2013
• Results First Posted: March 25, 2013

Record last verified: 2013-02