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The purpose of this study is to evaluate the safety and efficacy of DF277 for the treatment of otic eczema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DF277 | Experimental | Two administrations daily for 7 days |
|
| Placebo | Placebo Comparator | Two administrations daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DF277 | Drug | Two administrations daily for 7 days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of the Itching Change at the End of Treatment. | The analysis of the itching change at the end of treatment (mean itching on days 4-8 compared to baseline). Itching was assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe | Baseline and days 4-8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Signs/ Symptoms | - Change in itching at follow-up (mean itching on days 9-15 compared to baseline). | Baseline and days 9-15 |
| Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Treatment (Day 8) Compared to Baseline (Day 1). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratorios SALVAT, S.A. | Esplugues de Llobregat | Barcelone | 08950 | Spain |
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| ID | Title | Description |
|---|---|---|
| FG000 | DF277 | Two administrations daily for 7 days DF277: Two administrations daily for 7 days |
| FG001 | Placebo | Two administrations daily for 7 days Placebo: Two administrations daily for 7 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DF277 | Two administrations daily for 7 days DF277: Two administrations daily for 7 days |
| BG001 | Placebo | Two administrations daily for 7 days Placebo: Two administrations daily for 7 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Analysis of the Itching Change at the End of Treatment. | The analysis of the itching change at the end of treatment (mean itching on days 4-8 compared to baseline). Itching was assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe | Posted | Mean | Standard Deviation | units on a scale | Baseline and days 4-8 |
|
During all the study (15 days)
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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 | DF277 | Two administrations daily for 7 days DF277: Two administrations daily for 7 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear discomfort | Ear and labyrinth disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Enrique Jimenez, Medical Director | Laboratorios SALVAT | +34933946470 | ejimenezv@salvatbiotech.com |
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| Drug |
Two administrations daily for 7 days |
|
Analysis of the change on global scores of otoscopic signs at the end of treatment (mean global scores of otoscopic signs on day 8 compared to baseline). Erythema, edema and scaling were assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe. |
| Baseline and day 8 |
| Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Follow-up (Day 15) Compared to Baseline (Day 1). | Analysis of the change on global scores of otoscopic signs at the end of treatment (mean global scores of otoscopic signs on day 15 compared to baseline). Erythema, edema and scaling were assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe. | Baseline and day 15 |
| Adverse Event |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Signs/ Symptoms | - Change in itching at follow-up (mean itching on days 9-15 compared to baseline). | Posted | Mean | Standard Deviation | units on a scale | Baseline and days 9-15 |
|
|
|
| Secondary | Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Treatment (Day 8) Compared to Baseline (Day 1). | Analysis of the change on global scores of otoscopic signs at the end of treatment (mean global scores of otoscopic signs on day 8 compared to baseline). Erythema, edema and scaling were assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe. | Posted | Mean | Standard Deviation | units on a scale | Baseline and day 8 |
|
|
|
| Secondary | Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Follow-up (Day 15) Compared to Baseline (Day 1). | Analysis of the change on global scores of otoscopic signs at the end of treatment (mean global scores of otoscopic signs on day 15 compared to baseline). Erythema, edema and scaling were assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe. | Posted | Mean | Standard Deviation | units on a scale | Baseline and day 15 |
|
|
|
| 0 |
| 66 |
| 4 |
| 66 |
| EG001 | Placebo | Two administrations daily for 7 days Placebo: Two administrations daily for 7 days | 0 | 69 | 10 | 69 |
| Otitis externa | Ear and labyrinth disorders | MedDRA (16.0) | Systematic Assessment |
|
Sponsor does not object to publication by Institution of the results of the Trial based on information collected or generated by Institution, whether or not the results are favorable to the Sponsor Drug. However, to ensure against inadvertent disclosure of Confidential Information or unprotected Inventions, Institution will provide Sponsor an opportunity to review any proposed publication or other type of disclosure before it is submitted or otherwise disclosed.