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

Salvat

Status and phase: Completed; Phase 3

Conditions: Otic Eczema

Treatments: Drug: Placebo; Drug: DF277

Study type: Interventional

Funder types: Industry

Identifiers

NCT01996748

DF277OTIII/11ES01

Details and patient eligibility

About

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

Enrollment: 135 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Other diseases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 2 patient groups, including a placebo group

DF277

Experimental group

Description:

Two administrations daily for 7 days

Treatment:

Drug: DF277

Placebo

Placebo Comparator group

Description:

Two administrations daily for 7 days

Treatment:

Drug: Placebo