Trial Outcomes & Findings for Randomized, Double-blind, Multiple-site, Placebo-controlled, Parallel-design Study in Patients With Moderate to Severe Facial Erythema Associated With Rosacea (NCT NCT02289352)

Last Updated: 2020-01-14

Results Overview

Percentage of patients with a clinical response of treatment success on Day 7 (± 1). Treatment success is defined as at least a 2-grade improvement on both CEA and PSA scores from baseline (pre-dose) on Day 7 (± 1) to 6 hours post-application on Day 7 (± 1).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

462 participants

Primary outcome timeframe

7 days

Results posted on

2020-01-14

Participant Flow

514 patients were screened for study participation and 462 patients were randomized and included in the statistical analysis. The populations for this study included the Safety population, the Per-Protocol (PP) population and the modified Intent-to-Treat (mITT) Population.

Participant milestones

Participant milestones
Measure	Test: Brimonidine 0.33% Gel Brimonidine Topical Gel, 0.33%, 30 gram fill (Watson Laboratories, Inc., USA) Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days).	Reference: Mirvaso 0.33% Gel Mirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA) Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days).	Placebo Gel Vehicle Topical gel base only (Watson Laboratories Inc., USA) Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days).
Overall Study STARTED	199	199	64
Overall Study Safety Population	199	199	64
Overall Study mITT Population	191	193	58
Overall Study PP Population	173	173	54
Overall Study COMPLETED	198	198	64
Overall Study NOT COMPLETED	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Test: Brimonidine 0.33% Gel Brimonidine Topical Gel, 0.33%, 30 gram fill (Watson Laboratories, Inc., USA) Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days).	Reference: Mirvaso 0.33% Gel Mirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA) Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days).	Placebo Gel Vehicle Topical gel base only (Watson Laboratories Inc., USA) Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days).
Overall Study Withdrawal by Subject	1	1	0

Baseline Characteristics

Randomized, Double-blind, Multiple-site, Placebo-controlled, Parallel-design Study in Patients With Moderate to Severe Facial Erythema Associated With Rosacea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test:Brimonidine 0.33% Gel n=199 Participants Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days).	Reference: Mirvaso 0.33% Gel n=199 Participants Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days).	Placebo Gel Vehicle n=64 Participants Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days).	Total n=462 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	163 Participants n=93 Participants	167 Participants n=4 Participants	54 Participants n=27 Participants	384 Participants n=483 Participants
Age, Categorical >=65 years	36 Participants n=93 Participants	32 Participants n=4 Participants	10 Participants n=27 Participants	78 Participants n=483 Participants
Sex: Female, Male Female	151 Participants n=93 Participants	156 Participants n=4 Participants	53 Participants n=27 Participants	360 Participants n=483 Participants
Sex: Female, Male Male	48 Participants n=93 Participants	43 Participants n=4 Participants	11 Participants n=27 Participants	102 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	60 Participants n=93 Participants	65 Participants n=4 Participants	19 Participants n=27 Participants	144 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	139 Participants n=93 Participants	134 Participants n=4 Participants	45 Participants n=27 Participants	318 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) White	198 Participants n=93 Participants	198 Participants n=4 Participants	64 Participants n=27 Participants	460 Participants n=483 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants

PRIMARY outcome

Timeframe: 7 days

Population: Participants in the mITT Population that were evaluated for percentage of treatment successes.

Outcome measures

Outcome measures
Measure	Test: Brimonidine 0.33% Gel n=191 Participants Brimonidine Topical Gel, 0.33%, 30 gram fill (Watson Laboratories, Inc., USA) Test Brimonidine	Reference: Mirvaso 0.33% Gel n=193 Participants Mirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA) Reference Brimonidine	Placebo n=58 Participants Vehicle gel
Primary: Percentage of Treatment Success on Day 7	9.95 percentage of participants	10.36 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 1 day

Outcome measures

Outcome measures
Measure	Test: Brimonidine 0.33% Gel n=191 Participants Brimonidine Topical Gel, 0.33%, 30 gram fill (Watson Laboratories, Inc., USA) Test Brimonidine	Reference: Mirvaso 0.33% Gel n=193 Participants Mirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA) Reference Brimonidine	Placebo n=58 Participants Vehicle gel
Percentage of Patients With a Clinical Response of Treatment Success on Day 1	30.89 percentage of participants	30.89 percentage of participants	8.62 percentage of participants

Adverse Events

Test:Brimonidine 0.33% Gel

Serious events: 0 serious events

Other events: 26 other events

Deaths: 26 deaths

Reference: Mirvaso 0.33% Gel

Serious events: 0 serious events

Other events: 22 other events

Deaths: 22 deaths

Placebo Gel Vehicle

Serious events: 0 serious events

Other events: 4 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Director, CE Studies

Teva Pharmaceuticals USA, Inc.

Phone: 1-888-483-8279

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
Publication restrictions are in place

Restriction type: OTHER

Measure	Test:Brimonidine 0.33% Gel n=199 participants at risk Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days).	Reference: Mirvaso 0.33% Gel n=199 participants at risk Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days).	Placebo Gel Vehicle n=64 participants at risk Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days).
Gastrointestinal disorders Dry Mouth	0.50% 1/199 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/199 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
General disorders Application site acne	0.50% 1/199 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/199 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
Infections and infestations Nasopharyngitis	0.50% 1/199 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/199 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
Injury, poisoning and procedural complications Laceration	0.50% 1/199 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/199 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
Investigations Heart Rate Increased	0.00% 0/199 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.50% 1/199 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/199 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/199 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	1.6% 1/64 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
Nervous system disorders Burning sensation	2.0% 4/199 • Number of events 4 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	4.5% 9/199 • Number of events 10 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
Psychiatric disorders Stress	0.50% 1/199 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/199 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/199 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/199 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	1.6% 1/64 • Number of events 2 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
Skin and subcutaneous tissue disorders Pruritus	0.50% 1/199 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.50% 1/199 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
Vascular disorders Flushing	3.0% 6/199 • Number of events 11 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	2.5% 5/199 • Number of events 8 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	1.6% 1/64 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Nausea	0.50% 1/199 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/199 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
General disorders Application site erythema	2.5% 5/199 • Number of events 13 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	3.5% 7/199 • Number of events 11 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
General disorders Application site irritation	0.50% 1/199 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/199 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
General disorders Application site pain	2.5% 5/199 • Number of events 5 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	1.0% 2/199 • Number of events 2 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
General disorders Application site papules	0.50% 1/199 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/199 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
General disorders Application site pruritus	2.0% 4/199 • Number of events 4 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	1.0% 2/199 • Number of events 3 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	1.6% 1/64 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
General disorders Application site warmth	1.0% 2/199 • Number of events 10 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	1.0% 2/199 • Number of events 4 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
Infections and infestations Tooth abscess	0.00% 0/199 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.50% 1/199 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/199 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.50% 1/199 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.50% 1/199 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/199 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
Nervous system disorders Headache	2.0% 4/199 • Number of events 4 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	3.0% 6/199 • Number of events 7 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
Nervous system disorders Hyperaesthesia	0.00% 0/199 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.50% 1/199 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.
Nervous system disorders Migraine	0.00% 0/199 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.50% 1/199 • Number of events 1 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/64 • Baseline to Day 7 Adverse events were collected from participants who were randomized and received the study drug.