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NCT Number: NCT01769339

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

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).

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Key information

Conditions

Vulva; Candidiasis Bacterial Infections and Mycoses Candidiasis Infections Mycoses

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Mean Time to Itch Relief

    Time frame: 1-hour after initial application

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

Secondary outcomes

  1. Percentage of Participants Who Achieved Clinical Cure

    Time frame: Baseline up to Day 28

    Participants were considered as clinically cured if the potassium hydroxide (KOH) mount / Gram stain (a method used to diagnose bacterial infection) test was negative for infection.

  2. Modified Itch Severity Scale (MISS) Score

    Time frame: Baseline and Day 28

    The MISS is a specific instrument for assessing and quantifying the intensity of pruritus. The MISS score ranges from 0 to 21, where 0=no itching and 21=very severe itching.

  3. Pruritus Symptom Assessment by Visual Analog Scale (VAS) Score

    Time frame: 1-hour after initial application

    Pruritus is assessed by using a 100 millimeter (mm) of VAS score ranges from 0 to 100 mm, where 0 mm=no pruritus and 100 mm=worse pruritus.

Sponsors and collaborators

Lead sponsor

Janssen Pharmaceutica

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 16, 2013
Registry last updated
Mar 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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