Trial Outcomes & Findings for Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis (NCT NCT02785159)

NCT ID: NCT02785159

Last Updated: 2020-08-20

Results Overview

Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear". The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 152 participants
• Primary outcome timeframe: 12 Weeks
• Results posted on: 2020-08-20

Participant Flow

Participant milestones

Measure	IDP-118 Lotion Lotion IDP-118 Lotion: Lotion	Tazorac Cream Cream Tazorac Cream: Cream	IDP 118 Vehicle Lotion Lotion IDP-118 Vehicle Lotion: Lotion	IDP-118 Vehicle Cream Cream IDP-118 Vehicle Cream: Cream
Overall Study STARTED	62	58	15	17
Overall Study COMPLETED	51	45	12	14
Overall Study NOT COMPLETED	11	13	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis

Baseline characteristics by cohort

Measure	IDP-118 Lotion n=62 Participants Lotion IDP-118 Lotion: Lotion	Tazorac Cream n=58 Participants Cream Tazorac Cream: Cream	IDP 118 Vehicle Lotion n=15 Participants Lotion IDP-118 Vehicle Lotion: Lotion	IDP-118 Vehicle Cream n=17 Participants Cream IDP-118 Vehicle Cream: Cream	Total n=152 Participants Total of all reporting groups
Age, Continuous	49.4 years STANDARD_DEVIATION 14.58 • n=5 Participants	48.4 years STANDARD_DEVIATION 12.37 • n=7 Participants	48.9 years STANDARD_DEVIATION 14.78 • n=5 Participants	56.8 years STANDARD_DEVIATION 11.92 • n=4 Participants	49.81 years STANDARD_DEVIATION 13.61 • n=21 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	24 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	56 Participants n=21 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	34 Participants n=7 Participants	8 Participants n=5 Participants	12 Participants n=4 Participants	96 Participants n=21 Participants

PRIMARY outcome

Timeframe: 12 Weeks

Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear". The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).

Outcome measures

Measure	IDP-118 Lotion n=62 Participants Lotion IDP-118 Lotion: Lotion	Tazorac Cream n=58 Participants Cream Tazorac Cream: Cream	IDP 118 Vehicle Lotion n=15 Participants Lotion IDP-118 Vehicle Lotion: Lotion	IDP-118 Vehicle Cream n=17 Participants Cream IDP-118 Vehicle Cream: Cream
Percent of Subjects With Treatment Success, Defined by at Least a 2 Grade Improvement From Baseline in the Investigator Global Assessment (IGA) Score Equating to Clear or Almost Clear.	31.66 percentage of participants	13.77 percentage of participants	15.90 percentage of participants	7.96 percentage of participants

Adverse Events

IDP-118 Lotion

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Tazorac Cream

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

IDP 118 Vehicle Lotion

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

IDP-118 Vehicle Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	IDP-118 Lotion n=60 participants at risk Lotion IDP-118 Lotion: Lotion	Tazorac Cream n=57 participants at risk Cream Tazorac Cream: Cream	IDP 118 Vehicle Lotion n=15 participants at risk Lotion IDP-118 Vehicle Lotion: Lotion	IDP-118 Vehicle Cream n=16 participants at risk Cream IDP-118 Vehicle Cream: Cream
General disorders Chest pain	1.7% 1/60 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).	1.8% 1/57 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).	0.00% 0/15 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).	0.00% 0/16 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).

Other adverse events

Measure	IDP-118 Lotion n=60 participants at risk Lotion IDP-118 Lotion: Lotion	Tazorac Cream n=57 participants at risk Cream Tazorac Cream: Cream	IDP 118 Vehicle Lotion n=15 participants at risk Lotion IDP-118 Vehicle Lotion: Lotion	IDP-118 Vehicle Cream n=16 participants at risk Cream IDP-118 Vehicle Cream: Cream
Skin and subcutaneous tissue disorders Skin atrophy	5.0% 3/60 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).	0.00% 0/57 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).	0.00% 0/15 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).	0.00% 0/16 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).
General disorders Application site pain	6.7% 4/60 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).	5.3% 3/57 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).	13.3% 2/15 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).	0.00% 0/16 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).
General disorders Application site pruritis	3.3% 2/60 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).	3.5% 2/57 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).	13.3% 2/15 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).	0.00% 0/16 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).
Skin and subcutaneous tissue disorders Dermatitis contact	1.7% 1/60 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).	5.3% 3/57 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).	0.00% 0/15 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).	0.00% 0/16 • 12 weeks Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).

Additional Information

Study Director

Bausch Health

Email: anya.loncaric@bauschhealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee Contact sponsor directly for details.
• Publication restrictions are in place

Restriction type: OTHER