Trial · NCT01769339
An Efficacy and Safety Study of Miconazole and Hydrocortisone Cream in the Treatment of Vulvar Candidiasis
NCT01769339, Phase 4, Completed, Janssen Pharmaceutica; results first posted 2013-03-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Efficacy and Safety Study of Miconazole and Hydrocortisone Cream in the Treatment of Vulvar Candidiasis. Trials, record NCT01769339. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01769339
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Study of Miconazole and Hydrocortisone Cream in the Treatment of Vulvar Candidiasis
- NCT number
- NCT01769339
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 115 participants, actual
- Lead sponsor
- Janssen Pharmaceutica
- Conditions
- Vulva; Candidiasis
- Interventions
- Miconazole plus Hydrocortisone
- First posted
- 2013-01-16
- Last updated
- 2013-03-25
- Results first posted
- 2013-03-25
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Time to Itch Relief | 1-hour after initial application | Analysis population included all the participants who received at least 1 dose of study medication. | minutes | MEAN |
| SECONDARY | Percentage of Participants Who Achieved Clinical Cure | Baseline up to Day 28 | 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. | percentage of participants | NUMBER |
| SECONDARY | Modified Itch Severity Scale (MISS) Score | Baseline and Day 28 | 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. | units on a scale | MEAN |
| SECONDARY | Pruritus Symptom Assessment by Visual Analog Scale (VAS) Score | 1-hour after initial application | Data was not collected as only few participants had pruritus after 1-hour of study drug application. |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Time to Itch Relief | Miconazole Plus Hydrocortisone | 13.36 | Standard Error 1.41 | minutes | |
| Percentage of Participants Who Achieved Clinical Cure | Miconazole Plus Hydrocortisone | 97.30 | percentage of participants | ||
| Modified Itch Severity Scale (MISS) Score | Miconazole Plus Hydrocortisone | Baseline (n=115) | 7.25 | Standard Deviation 2.57 | units on a scale |
| Modified Itch Severity Scale (MISS) Score | Miconazole Plus Hydrocortisone | Day 28 (n=7) | 4.27 | Standard Deviation 0.63 | units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Miconazole Plus Hydrocortisone | 115 | |
| Overall Study | COMPLETED | Miconazole Plus Hydrocortisone | 72 | |
| Overall Study | NOT COMPLETED | Miconazole Plus Hydrocortisone | 43 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pruritus | Skin and subcutaneous tissue disorders | Miconazole Plus Hydrocortisone | 2 | 115 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Miconazole Plus Hydrocortisone | ||
| Total, other adverse events | Miconazole Plus Hydrocortisone | 2 | 115 |
| Total, serious adverse events | Miconazole Plus Hydrocortisone | 0 | 115 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01769339
GET https://conductscience.org/api/trials/v1/NCT01769339/registered