Back to resultsClinical Study to Assess the Efficacy and Safety of DF277 Compared to Placebo in the Treatment of Otic Eczema
Primary Purpose
Otic Eczema
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
DF277
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Otic Eczema
Eligibility Criteria
Inclusion Criteria:
- 12 years or older
- Clinical diagnosis of otic eczema suitable for local treatment
Exclusion Criteria:
- Other diseases.
Sites / Locations
- Laboratorios SALVAT, S.A.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DF277
Placebo
Arm Description
Two administrations daily for 7 days
Two administrations daily for 7 days
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in Signs/ Symptoms
- Change in itching at follow-up (mean itching on days 9-15 compared to baseline).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01996748
Brief Title
Clinical Study to Assess the Efficacy and Safety of DF277 Compared to Placebo in the Treatment of Otic Eczema
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Salvat
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of DF277 for the treatment of otic eczema.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otic Eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DF277
Arm Type
Experimental
Arm Description
Two administrations daily for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two administrations daily for 7 days
Intervention Type
Drug
Intervention Name(s)
DF277
Intervention Description
Two administrations daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two administrations daily for 7 days
Primary Outcome Measure Information:
Title
Analysis of the Itching Change at the End of Treatment.
Description
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
Time Frame
Baseline and days 4-8
Secondary Outcome Measure Information:
Title
Change in Signs/ Symptoms
Description
- Change in itching at follow-up (mean itching on days 9-15 compared to baseline).
Time Frame
Baseline and days 9-15
Title
Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Treatment (Day 8) Compared to Baseline (Day 1).
Description
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.
Time Frame
Baseline and day 8
Title
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).
Description
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.
Time Frame
Baseline and day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
12 years or older
Clinical diagnosis of otic eczema suitable for local treatment
Exclusion Criteria:
Other diseases.
Facility Information:
Facility Name
Laboratorios SALVAT, S.A.
City
Esplugues de Llobregat
State/Province
Barcelone
ZIP/Postal Code
08950
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Clinical Study to Assess the Efficacy and Safety of DF277 Compared to Placebo in the Treatment of Otic Eczema
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