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| ID | Type | Description | Link |
|---|---|---|---|
| MICFUN4001 |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Miconazole plus Hydrocortisone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Time to Itch Relief | Time to itch relief is defined as time needed to achieve pruritus (itchiness) relief. | 1-hour after initial application |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Clinical Cure | 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. | Baseline up to Day 28 |
| Modified Itch Severity Scale (MISS) Score |
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutica Clinical Trial | Janssen Pharmaceutica | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Miconazole Plus Hydrocortisone | Participants applied miconazole plus hydrocortisone cream topically (applied to skin) to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis (yeast infection of the vulva) were not cured clinically on Day 14. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Miconazole Plus Hydrocortisone | Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Time to Itch Relief | Time to itch relief is defined as time needed to achieve pruritus (itchiness) relief. | Analysis population included all the participants who received at least 1 dose of study medication. | Posted | Mean | Standard Error | minutes | 1-hour after initial application |
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From signing of informed consent until 30 days after the last dose of study medication
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Miconazole Plus Hydrocortisone | Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Manager | Janssen Philippines | +6328248935 |
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| ID | Term |
|---|---|
| D002177 | Candidiasis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D008825 | Miconazole |
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
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. |
| Baseline and Day 28 |
| Pruritus Symptom Assessment by Visual Analog Scale (VAS) Score | 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. | 1-hour after initial application |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Participants |
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| Secondary | Percentage of Participants Who Achieved Clinical Cure | 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. | Analysis population included all the participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | percentage of participants | Baseline up to Day 28 |
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|
|
| Secondary | Modified Itch Severity Scale (MISS) Score | 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. | Analysis Population included all the participants who received at least 1 dose of study medication. Here 'n' signifies those participants who were evaluable at specified time-point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 28 |
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| Secondary | Pruritus Symptom Assessment by Visual Analog Scale (VAS) Score | 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. | Data was not collected as only few participants had pruritus after 1-hour of study drug application. | Posted | 1-hour after initial application |
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| 0 |
| 115 |
| 2 |
| 115 |
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| D011282 |
| Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |