Otic Eczema
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of DF277 for the treatment of otic eczema.
Interventions
DRUGDF277
Two administrations daily for 7 days
DRUGPlacebo
Two administrations daily for 7 days
Sponsors
Salvat
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 12 years or older * Clinical diagnosis of otic eczema suitable for local treatment
Exclusion criteria
* Other diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of the Itching Change at the End of Treatment. | Baseline and days 4-8 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Signs/ Symptoms | Baseline and days 9-15 | \- Change in itching at follow-up (mean itching on days 9-15 compared to baseline). |
| Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Treatment (Day 8) Compared to Baseline (Day 1). | Baseline and day 8 | 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. |
| 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). | Baseline and day 15 | 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. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DF277 Two administrations daily for 7 days
DF277: Two administrations daily for 7 days | 66 |
| Placebo Two administrations daily for 7 days
Placebo: Two administrations daily for 7 days | 69 |
| Total | 135 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 4 |
| Overall Study | Lost to Follow-up | 4 | 1 |
| Overall Study | Personal reason | 1 | 0 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | DF277 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 14 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 52 Participants | 109 Participants |
| Age, Continuous | 52.2 years STANDARD_DEVIATION 11.9 | 52.8 years STANDARD_DEVIATION 12.7 | 52.6 years STANDARD_DEVIATION 12.8 |
| Region of Enrollment Spain | 69 participants | 66 participants | 135 participants |
| Sex: Female, Male Female | 61 Participants | 48 Participants | 109 Participants |
| Sex: Female, Male Male | 8 Participants | 18 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 66 | 10 / 69 |
| serious Total, serious adverse events | 0 / 66 | 0 / 69 |
Outcome results
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
Time frame: Baseline and days 4-8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DF277 | Analysis of the Itching Change at the End of Treatment. | -1.63 units on a scale | Standard Deviation 0.82 |
| Placebo | Analysis of the Itching Change at the End of Treatment. | -1.25 units on a scale | Standard Deviation 0.72 |
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.
Time frame: Baseline and day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DF277 | 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). | -1.20 units on a scale | Standard Deviation 0.68 |
| Placebo | 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). | -0.77 units on a scale | Standard Deviation 0.72 |
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.
Time frame: Baseline and day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DF277 | Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Treatment (Day 8) Compared to Baseline (Day 1). | -1.21 units on a scale | Standard Deviation 0.68 |
| Placebo | Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Treatment (Day 8) Compared to Baseline (Day 1). | -0.78 units on a scale | Standard Deviation 0.68 |
Secondary
Change in Signs/ Symptoms
\- Change in itching at follow-up (mean itching on days 9-15 compared to baseline).
Time frame: Baseline and days 9-15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DF277 | Change in Signs/ Symptoms | -1.80 units on a scale | Standard Deviation 0.81 |
| Placebo | Change in Signs/ Symptoms | -1.32 units on a scale | Standard Deviation 0.77 |