Otic Eczema Clinical Trial
Official title:
A Multicenter, Randomized, Parallel, Double-blind, Clinical Trial Study to Assess the Efficacy and Safety of DF277 Compared to Placebo in Patients With Otic Eczema
| Verified date | November 2013 |
| Source | Salvat |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
| Study type | Interventional |
The purpose of this study is to evaluate the safety and efficacy of DF277 for the treatment of otic eczema.
| Status | Completed |
| Enrollment | 135 |
| Est. completion date | March 2013 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
Inclusion Criteria: - 12 years or older - Clinical diagnosis of otic eczema suitable for local treatment Exclusion Criteria: - Other diseases. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Laboratorios SALVAT, S.A. | Esplugues de Llobregat | Barcelone |
| Lead Sponsor | Collaborator |
|---|---|
| Salvat |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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). | Baseline and days 4-8 | No |
| Secondary | Change in signs/ symptoms | Change in itching at follow-up (mean itching on days 9-15 compared to baseline). Change in mean scores of otoscopic signs (erythema, edema and scaling) at the end of treatment (day 8) compared to baseline (day 1). Change in mean scores of otoscopic signs (erythema, edema and scaling) at follow- up (day 15) compared to baseline (day 1). |
Baseline and 2 weeks | No |