Trial Outcomes & Findings for An Efficacy and Safety Study of Miconazole and Hydrocortisone Cream in the Treatment of Vulvar Candidiasis (NCT NCT01769339)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

115 participants

Primary outcome timeframe

1-hour after initial application

Results posted on

2013-03-25

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	115
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	43

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	42
Overall Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Miconazole Plus Hydrocortisone n=115 Participants 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.
Age Continuous	37.76 years STANDARD_DEVIATION 9.39 • n=5 Participants
Sex: Female, Male Female	115 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-hour after initial application

Population: Analysis population included all the participants who received at least 1 dose of study medication.

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

Outcome measures

Outcome measures
Measure	Miconazole Plus Hydrocortisone n=115 Participants 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.
Mean Time to Itch Relief	13.36 minutes Standard Error 1.41

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Miconazole Plus Hydrocortisone n=74 Participants 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.
Percentage of Participants Who Achieved Clinical Cure	97.30 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Miconazole Plus Hydrocortisone n=115 Participants 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.
Modified Itch Severity Scale (MISS) Score Baseline (n=115)	7.25 units on a scale Standard Deviation 2.57
Modified Itch Severity Scale (MISS) Score Day 28 (n=7)	4.27 units on a scale Standard Deviation 0.63

SECONDARY outcome

Timeframe: 1-hour after initial application

Population: Data was not collected as only few participants had pruritus after 1-hour of study drug 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.

Outcome measures

Outcome data not reported

Adverse Events

Miconazole Plus Hydrocortisone

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Miconazole Plus Hydrocortisone n=115 participants at risk 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.
Skin and subcutaneous tissue disorders Pruritus	1.7% 2/115 • From signing of informed consent until 30 days after the last dose of study medication

Additional Information

Medical Affairs Manager

Janssen Philippines

Phone: +6328248935

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place