Trial Outcomes & Findings for Clinical Study to Assess the Efficacy and Safety of DF277 Compared to Placebo in the Treatment of Otic Eczema (NCT NCT01996748)

NCT ID: NCT01996748

Last Updated: 2017-05-30

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 135 participants
• Primary outcome timeframe: Baseline and days 4-8
• Results posted on: 2017-05-30

Participant Flow

Participant milestones

Measure	DF277 Two administrations daily for 7 days DF277: Two administrations daily for 7 days	Placebo Two administrations daily for 7 days Placebo: Two administrations daily for 7 days
Overall Study STARTED	66	69
Overall Study COMPLETED	58	63
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Measure	DF277 Two administrations daily for 7 days DF277: Two administrations daily for 7 days	Placebo Two administrations daily for 7 days Placebo: Two administrations daily for 7 days
Overall Study Personal reason	1	0
Overall Study Physician Decision	2	0
Overall Study Adverse Event	1	4
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	4	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	DF277 n=66 Participants Two administrations daily for 7 days DF277: Two administrations daily for 7 days	Placebo n=69 Participants Two administrations daily for 7 days Placebo: Two administrations daily for 7 days	Total n=135 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	57 Participants n=7 Participants	109 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Age, Continuous	52.8 years STANDARD_DEVIATION 12.7 • n=5 Participants	52.2 years STANDARD_DEVIATION 11.9 • n=7 Participants	52.6 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	61 Participants n=7 Participants	109 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	8 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment Spain	66 participants n=5 Participants	69 participants n=7 Participants	135 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and days 4-8

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

Outcome measures

Measure	DF277 n=66 Participants Two administrations daily for 7 days DF277: Two administrations daily for 7 days	Placebo n=69 Participants Two administrations daily for 7 days Placebo: Two administrations daily for 7 days
Analysis of the Itching Change at the End of Treatment.	-1.63 units on a scale Standard Deviation 0.82	-1.25 units on a scale Standard Deviation 0.72

SECONDARY outcome

Timeframe: Baseline and days 9-15

• Change in itching at follow-up (mean itching on days 9-15 compared to baseline).

Outcome measures

Measure	DF277 n=66 Participants Two administrations daily for 7 days DF277: Two administrations daily for 7 days	Placebo n=69 Participants Two administrations daily for 7 days Placebo: Two administrations daily for 7 days
Change in Signs/ Symptoms	-1.80 units on a scale Standard Deviation 0.81	-1.32 units on a scale Standard Deviation 0.77

SECONDARY outcome

Timeframe: Baseline and day 8

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.

Outcome measures

Measure	DF277 n=66 Participants Two administrations daily for 7 days DF277: Two administrations daily for 7 days	Placebo n=69 Participants Two administrations daily for 7 days Placebo: Two administrations daily for 7 days
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 units on a scale Standard Deviation 0.68	-0.78 units on a scale Standard Deviation 0.68

SECONDARY outcome

Timeframe: Baseline and day 15

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.

Outcome measures

Measure	DF277 n=66 Participants Two administrations daily for 7 days DF277: Two administrations daily for 7 days	Placebo n=69 Participants Two administrations daily for 7 days Placebo: Two administrations daily for 7 days
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 units on a scale Standard Deviation 0.68	-0.77 units on a scale Standard Deviation 0.72

Adverse Events

DF277

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	DF277 n=66 participants at risk Two administrations daily for 7 days DF277: Two administrations daily for 7 days	Placebo n=69 participants at risk Two administrations daily for 7 days Placebo: Two administrations daily for 7 days
Ear and labyrinth disorders Ear discomfort	6.1% 4/66 • Number of events 5 • During all the study (15 days)	7.2% 5/69 • Number of events 5 • During all the study (15 days)
Ear and labyrinth disorders Otitis externa	0.00% 0/66 • During all the study (15 days)	7.2% 5/69 • Number of events 5 • During all the study (15 days)

Additional Information

Enrique Jimenez, Medical Director

Laboratorios SALVAT

Phone: +34933946470

Email: ejimenezv@salvatbiotech.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor does not object to publication by Institution of the results of the Trial based on information collected or generated by Institution, whether or not the results are favorable to the Sponsor Drug. However, to ensure against inadvertent disclosure of Confidential Information or unprotected Inventions, Institution will provide Sponsor an opportunity to review any proposed publication or other type of disclosure before it is submitted or otherwise disclosed.
• Publication restrictions are in place

Restriction type: OTHER