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

NCT ID: NCT01996748

Last Updated: 2017-05-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-03-31

Brief Summary

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

Detailed Description

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Conditions

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Otic Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DF277

Two administrations daily for 7 days

Group Type EXPERIMENTAL

DF277

Intervention Type DRUG

Two administrations daily for 7 days

Placebo

Two administrations daily for 7 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Two administrations daily for 7 days

Interventions

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DF277

Two administrations daily for 7 days

Intervention Type DRUG

Placebo

Two administrations daily for 7 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Other diseases.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Salvat

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Laboratorios SALVAT, S.A.

Esplugues de Llobregat, Barcelone, Spain

Site Status

Countries

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Spain

Other Identifiers

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DF277OTIII/11ES01

Identifier Type: -

Identifier Source: org_study_id

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