Trial Outcomes & Findings for Comparative Safety and Efficacy of Two Rosacea Products in the Treatment of Facial Erythema of Rosacea (NCT NCT02385240)

NCT ID: NCT02385240

Last Updated: 2021-10-22

Results Overview

2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 552 participants
• Primary outcome timeframe: Day 15 at hour 6
• Results posted on: 2021-10-22

Participant Flow

Participant milestones

Measure	Test Product Brimonidine Topical Gel, 0.33 percent Brimonidine Topical Gel, 0.33 percent (Perrigo)	Reference Product Brimonidine Topical Gel, 0.33 percent (Reference) Brimonidine Topical Gel, 0.33 percent (Reference)	Placebo Gel Placebo Placebo gel
Overall Study STARTED	183	184	185
Overall Study COMPLETED	182	178	184
Overall Study NOT COMPLETED	1	6	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Safety and Efficacy of Two Rosacea Products in the Treatment of Facial Erythema of Rosacea

Baseline characteristics by cohort

Measure	Test Product n=183 Participants Brimonidine Topical Gel, 0.33 percent Brimonidine Topical Gel, 0.33 percent (Perrigo)	Reference Product n=184 Participants Brimonidine Topical Gel, 0.33 percent (Reference) Brimonidine Topical Gel, 0.33 percent (Reference)	Placebo Gel n=185 Participants Placebo Placebo gel	Total n=552 Participants Total of all reporting groups
Age, Continuous	50.4 years STANDARD_DEVIATION 12.5 • n=5 Participants	51.2 years STANDARD_DEVIATION 13.29 • n=7 Participants	50.9 years STANDARD_DEVIATION 12.27 • n=5 Participants	50.8 years STANDARD_DEVIATION 12.67 • n=4 Participants
Sex: Female, Male Female	138 Participants n=5 Participants	156 Participants n=7 Participants	137 Participants n=5 Participants	431 Participants n=4 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	28 Participants n=7 Participants	48 Participants n=5 Participants	121 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=5 Participants	29 Participants n=7 Participants	18 Participants n=5 Participants	71 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	159 Participants n=5 Participants	155 Participants n=7 Participants	167 Participants n=5 Participants	481 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	181 Participants n=5 Participants	184 Participants n=7 Participants	181 Participants n=5 Participants	546 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 15 at hour 6

Population: Per protocol population

2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales

Outcome measures

Measure	Test Product n=168 Participants Brimonidine Topical Gel, 0.33 percent Brimonidine Topical Gel, 0.33 percent (Perrigo)	Reference Product n=170 Participants Brimonidine Topical Gel, 0.33 percent (Reference) Brimonidine Topical Gel, 0.33 percent (Reference)	Placebo Gel n=179 Participants Placebo Placebo gel
Proportion of Subjects With Composite Success	60 Participants	58 Participants	23 Participants

SECONDARY outcome

Timeframe: Day 15 at hour 3

Population: Per protocol population

2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales

Outcome measures

Measure	Test Product n=168 Participants Brimonidine Topical Gel, 0.33 percent Brimonidine Topical Gel, 0.33 percent (Perrigo)	Reference Product n=170 Participants Brimonidine Topical Gel, 0.33 percent (Reference) Brimonidine Topical Gel, 0.33 percent (Reference)	Placebo Gel n=179 Participants Placebo Placebo gel
Proportion of Subjects With Composite Success	61 Participants	58 Participants	19 Participants

SECONDARY outcome

Timeframe: Day 15 at hour 9

Population: Per protocol population

2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales

Outcome measures

Measure	Test Product n=168 Participants Brimonidine Topical Gel, 0.33 percent Brimonidine Topical Gel, 0.33 percent (Perrigo)	Reference Product n=170 Participants Brimonidine Topical Gel, 0.33 percent (Reference) Brimonidine Topical Gel, 0.33 percent (Reference)	Placebo Gel n=179 Participants Placebo Placebo gel
Proportion of Subjects With Composite Success	53 Participants	42 Participants	18 Participants

Adverse Events

Test Product

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Reference Product

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Test Product n=183 participants at risk Brimonidine Topical Gel, 0.33 percent Brimonidine Topical Gel, 0.33 percent (Perrigo)	Reference Product n=184 participants at risk Brimonidine Topical Gel, 0.33 percent (Reference) Brimonidine Topical Gel, 0.33 percent (Reference)	Placebo Gel n=185 participants at risk Placebo Placebo gel
Metabolism and nutrition disorders Diabetic Ketoacidosis	0.55% 1/183 • Number of events 1 • 15 days	0.00% 0/184 • 15 days	0.00% 0/185 • 15 days

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Schwartz

Perrigo

Phone: 718-960-9900

Email: jonathan.schwartz@perrigo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER