Phase 3
Completed N=135
Clinical Study to Assess the Efficacy and Safety of DF277 Compared to Placebo in the Treatment of Otic Eczema
Otic Eczema
Source: ClinicalTrials.gov NCT01996748 ↗
Enrolled (actual)
135
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Analysis of the Itching Change at the End of Treatment. — -1.63; -1.25 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to evaluate the safety and efficacy of DF277 for the treatment of otic eczema.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Analysis of the Itching Change at the End of Treatment. |
-1.63; -1.25 | — |
| SECONDARY Change in Signs/ Symptoms |
-1.80; -1.32 | — |
| 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). |
-1.21; -0.78 | — |
| 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). |
-1.20; -0.77 | — |
Eligibility Criteria
Inclusion Criteria
- 12 years or older
- Clinical diagnosis of otic eczema suitable for local treatment
Exclusion Criteria
- Other diseases.
Data sourced from ClinicalTrials.gov (NCT01996748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.