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

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

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

Study Overview

• Status: Completed
• Conditions: Otic Eczema
• Intervention / Treatment: Drug: DF277; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Barcelone
    • Esplugues de Llobregat, Barcelone, Spain, 08950
      • Laboratorios Salvat, S.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Other diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DF277; Two administrations daily for 7 days	Drug: DF277; Two administrations daily for 7 days
Placebo Comparator: Placebo; Two administrations daily for 7 days	Drug: Placebo; Two administrations daily for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and days 4-8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Signs/ Symptoms	- Change in itching at follow-up (mean itching on days 9-15 compared to baseline).	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.	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.	Baseline and day 15

Collaborators and Investigators

• Sponsor: Salvat

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: October 14, 2013
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (Estimate): November 27, 2013

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: DF277OTIII/11ES01