Phase 3 N=135 Randomized Double-blind Treatment

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

Otic Eczema

Bottom Line

View on ClinicalTrials.gov: NCT01996748 ↗

Enrolled (actual)

135

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Analysis of the Itching Change at the End of Treatment. — -1.63; -1.25 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: DF277 (Drug); Placebo (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Salvat
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Analysis of the Itching Change at the End of Treatment.	-1.63; -1.25	—
SECONDARY Change in Signs/ Symptoms	-1.80; -1.32	—
SECONDARY Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Treatment (Day 8) Compared to Baseline (Day 1).	-1.21; -0.78	—
SECONDARY 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).	-1.20; -0.77	—

Summary

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Other diseases.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01996748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.