NCT01996748

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

April 14, 2017

Completed
Last Updated

May 30, 2017

Status Verified

April 1, 2017

Enrollment Period

29 days

First QC Date

October 14, 2013

Results QC Date

December 21, 2016

Last Update Submit

April 25, 2017

Conditions

Otic Eczema

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in Signs/ Symptoms

    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).

    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).

    Baseline and day 15

Study Arms (2)

DF277

EXPERIMENTAL

Two administrations daily for 7 days

Drug: DF277

Placebo

PLACEBO COMPARATOR

Two administrations daily for 7 days

Drug: Placebo

Interventions

DF277DRUG

Two administrations daily for 7 days

DF277
PlaceboDRUG

Two administrations daily for 7 days

Placebo

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Other diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratorios SALVAT, S.A.

Esplugues de Llobregat, Barcelone, 08950, Spain

Location

Results Point of Contact

Title
Enrique Jimenez, Medical Director
Organization
Laboratorios SALVAT
ejimenezv@salvatbiotech.com
+34933946470

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2013

First Posted

November 27, 2013

Study Start

February 1, 2012

Primary Completion

March 1, 2012

Study Completion

March 1, 2013

Last Updated

May 30, 2017

Results First Posted

April 14, 2017

Record last verified: 2017-04

Locations

ES(1)