Vulva; CandidiasisPhase 4NCT01769339

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

A Phase 4 study testing Miconazole plus Hydrocortisone in people with Vulva; Candidiasis, run by Janssen Pharmaceutica.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages 18 to 60 years, women only
Conditions the study is for: Vulva; Candidiasis
What is being tested?: Miconazole plus Hydrocortisone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 115 participants
Where: No sites listed yet
Study dates: Jan 2009to Jun 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Women only
No healthy volunteers
Adult

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)

About this study

Official title: Effectiveness and Safety of Daktacort Feminine Care 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).

Read the 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.

Conditions: Vulva; Candidiasis
Being tested: Miconazole plus Hydrocortisone
Keywords: Vulvar Candidiasis, Miconazole, Hydrocortisone, Daktacort Feminine Care Cream
Medical subject headings: Candidiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Miconazole plus HydrocortisoneDrug
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.

Study groups in NCT01769339
Study group	Role	What they receive
Miconazole plus Hydrocortisone	Experimental	Not described Receives: Drug: Miconazole plus Hydrocortisone

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Time to Itch Relief
Time to itch relief is defined as time needed to achieve pruritus (itchiness) relief.
Measured: 1-hour after initial application

Secondary outcomes (3)

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.
Measured: Baseline up to Day 28
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.
Measured: 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.
Measured: 1-hour after initial application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Jun 2009

First posted16 Jan 2013 (estimated)
Study startJan 2009
Primary completionJun 2009
Study completionJun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Vulva; CandidiasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01769339
Sponsor's protocol ID: CR015721
Other IDs: MICFUN4001
Status last verified: Feb 2013
First submitted: 14 Jan 2013
Last updated: 25 Mar 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness and Safety of Daktacort Feminine Care Cream in the Treatment of Vulvar Candidiasis
ClinicalTrials.gov ID: NCT01769339
Acronym / sponsor ID: CR015721
Conditions: Vulva; Candidiasis
Keywords: Vulvar Candidiasis, Miconazole, Hydrocortisone, Daktacort Feminine Care Cream
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 115 participants (actual)
Lead sponsor: Janssen PharmaceuticaIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 16 Jan 2013 (estimated)
Results: Posted 25 Mar 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Miconazole plus Hydrocortisone	Experimental	Drug: Miconazole plus Hydrocortisone

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Miconazole plus HydrocortisoneParticipants 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.	Drug	Miconazole plus Hydrocortisone

Primary outcome

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.

3 secondary outcomes

Percentage of Participants Who Achieved Clinical Cure
Time frame: Baseline up to Day 28
Modified Itch Severity Scale (MISS) Score
Time frame: Baseline and Day 28
Pruritus Symptom Assessment by Visual Analog Scale (VAS) Score
Time frame: 1-hour after initial application

Results and safety

Results posted to the registry on 25 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Miconazole Plus Hydrocortisone	115	72

Primary outcome: Mean Time to Itch Relief

Time frame: 1-hour after initial application. Mean (Standard Error). Unit: minutes

Measure	Miconazole Plus Hydrocortisone n = 115
Value	13.36 (1.41)

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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing of informed consent until 30 days after the last dose of study medication. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Miconazole Plus Hydrocortisone	0 of 115 (0%)	2 of 115 (1.7%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Pharmaceutica Clinical Trial study director

Janssen Pharmaceutica

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Miconazole plus Hydrocortisone in people with Vulva; Candidiasis, run by Janssen Pharmaceutica.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Time to Itch Relief (time frame: 1-hour after initial application). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01769339.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2013; AzTrials last refreshed its copy on 8 Nov 2026.