Clinical Study to Assess the Efficacy and Safety of DF277 Compared to Placebo in the Treatment of Otic Eczema

Phase 3CompletedNCT01996748

Salvat135 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of DF277 for the treatment of otic eczema.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

135

Conditions

Otic Eczema

Interventions

DF277DRUG

Two administrations daily for 7 days

PlaceboDRUG

Two administrations daily for 7 days

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 12 years or older * Clinical diagnosis of otic eczema suitable for local treatment Exclusion Criteria: * Other diseases.

Locations (1)

Laboratorios SALVAT, S.A.

Esplugues de Llobregat, Barcelone, Spain

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

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

Data from ClinicalTrials.gov

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