Vulva; Candidiasis
Conditions
Keywords
Vulvar Candidiasis, Miconazole, Hydrocortisone, Daktacort Feminine Care Cream
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).
Detailed description
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.
Interventions
DRUGMiconazole 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.
Sponsors
Janssen Pharmaceutica
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time to Itch Relief | 1-hour after initial application | Time to itch relief is defined as time needed to achieve pruritus (itchiness) relief. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Clinical Cure | 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. |
| Modified Itch Severity Scale (MISS) Score | 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. |
| Pruritus Symptom Assessment by Visual Analog Scale (VAS) Score | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 115 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 42 |
Baseline characteristics
| Characteristic | Miconazole Plus Hydrocortisone |
|---|---|
| Age Continuous | 37.76 years STANDARD_DEVIATION 9.39 |
| Sex: Female, Male Female | 115 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 115 |
| serious Total, serious adverse events | 0 / 115 |
Outcome results
Primary
Mean Time to Itch Relief
Time to itch relief is defined as time needed to achieve pruritus (itchiness) relief.
Time frame: 1-hour after initial application
Population: Analysis population included all the participants who received at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Miconazole Plus Hydrocortisone | Mean Time to Itch Relief | 13.36 minutes | Standard Error 1.41 |
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.
Time frame: Baseline and Day 28
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Miconazole Plus Hydrocortisone | Modified Itch Severity Scale (MISS) Score | Baseline (n=115) | 7.25 units on a scale | Standard Deviation 2.57 |
| Miconazole Plus Hydrocortisone | Modified Itch Severity Scale (MISS) Score | Day 28 (n=7) | 4.27 units on a scale | Standard Deviation 0.63 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: Baseline up to Day 28
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Miconazole Plus Hydrocortisone | Percentage of Participants Who Achieved Clinical Cure | 97.30 percentage of participants |
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.
Time frame: 1-hour after initial application
Population: Data was not collected as only few participants had pruritus after 1-hour of study drug application.