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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations

NCT01039584

Vulvovaginal Candidiasis

COMPLETED NA

Ketoconazole Gel Versus Terconazole Cream for Vaginal Candidiasis

NCT03473418

Vaginal Candidiasis

UNKNOWN PHASE3

Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis

NCT04813822

Acute Vulvovaginal Candidiasis

UNKNOWN PHASE2

Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis)

NCT04432376

Otomycosis

COMPLETED PHASE2/PHASE3

Efficacy of Self Vs. Physician Application of Triamcinolone-Econazole in Otomycosis

NCT06431542

Otomycosis

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Vulva; Candidiasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Miconazole plus Hydrocortisone

Group Type EXPERIMENTAL

Miconazole plus Hydrocortisone

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No