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

Phase 3

Completed

• Conditions: Otic Eczema
• Interventions: Drug: DF277; Drug: Placebo

• Registration Number: NCT01996748
• Lead Sponsor: Salvat

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-03
• Study Completion: 2013-03
• Study First Submitted: 2013-10-14
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-27
• Results First Submitted: 2016-12-21
• Results First Submitted QC: 2017-03-02
• Status Verified: 2017-04
• Results First Posted: 2017-04-14
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• 12 years or older
• Clinical diagnosis of otic eczema suitable for local treatment

Exclusion Criteria

• Other diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DF277	DF277	Two administrations daily for 7 days
Placebo	Placebo	Two administrations daily for 7 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Change in Signs/ Symptoms	Baseline and days 9-15	- Change in itching at follow-up (mean itching on days 9-15 compared to baseline).

Trial Locations

Locations (1)

Laboratorios SALVAT, S.A.; 🇪🇸 Esplugues de Llobregat, Barcelone, Spain