Trial Outcomes & Findings for Bioequivalence Study of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea on the Face (NCT NCT02800148)

NCT ID: NCT02800148

Last Updated: 2021-11-08

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 667 participants
• Primary outcome timeframe: Day 84
• Results posted on: 2021-11-08

Participant Flow

Participant milestones

Measure	Azelaic Acid Foam Azelaic acid foam	Finacea Foam Azelaic acid foam	Placebo Foam Azelaic acid foam - Placebo
Overall Study STARTED	224	224	219
Overall Study COMPLETED	199	204	194
Overall Study NOT COMPLETED	25	20	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bioequivalence Study of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea on the Face

Baseline characteristics by cohort

Measure	Azelaic Acid Foam n=224 Participants Azelaic acid foam	Finacea Foam n=224 Participants Azelaic acid foam	Placebo Foam n=219 Participants Azelaic acid foam - Placebo	Total n=667 Participants Total of all reporting groups
Age, Continuous	51.6 years STANDARD_DEVIATION 13.85 • n=5 Participants	51.5 years STANDARD_DEVIATION 13.67 • n=7 Participants	49.0 years STANDARD_DEVIATION 12.42 • n=5 Participants	50.7 years STANDARD_DEVIATION 13.37 • n=4 Participants
Sex: Female, Male Female	164 Participants n=5 Participants	167 Participants n=7 Participants	166 Participants n=5 Participants	497 Participants n=4 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	57 Participants n=7 Participants	53 Participants n=5 Participants	170 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	60 Participants n=5 Participants	55 Participants n=7 Participants	68 Participants n=5 Participants	183 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	164 Participants n=5 Participants	169 Participants n=7 Participants	151 Participants n=5 Participants	484 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	0 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	9 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	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	221 Participants n=5 Participants	215 Participants n=7 Participants	211 Participants n=5 Participants	647 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	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 84

Outcome measures

Measure	Azelaic Acid Foam n=178 Participants Azelaic acid foam	Finacea Foam n=181 Participants Azelaic acid foam	Placebo Foam n=178 Participants Azelaic acid foam - Placebo
Percent Change (Reduction) of Lesion Count From Day 1	61.14 percentage of lesion reduction Standard Deviation 33.623	57.27 percentage of lesion reduction Standard Deviation 34.513	49.43 percentage of lesion reduction Standard Deviation 44.437

Adverse Events

Azelaic Acid Foam

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Finacea Foam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Foam

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Azelaic Acid Foam n=224 participants at risk Azelaic acid foam	Finacea Foam n=224 participants at risk Azelaic acid foam	Placebo Foam n=219 participants at risk Azelaic acid foam - Placebo
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Esophageal Cancer	0.45% 1/224 • 84 days	0.00% 0/224 • 84 days	0.00% 0/219 • 84 days
Infections and infestations Aseptic Meningitis	0.00% 0/224 • 84 days	0.00% 0/224 • 84 days	0.46% 1/219 • 84 days
Psychiatric disorders Major Depression	0.00% 0/224 • 84 days	0.00% 0/224 • 84 days	0.46% 1/219 • 84 days
Psychiatric disorders Suicidal ideation	0.00% 0/224 • 84 days	0.00% 0/224 • 84 days	0.46% 1/219 • 84 days

Other adverse events

Adverse event data not reported

Additional Information

Associate Director

Perrigo

Phone: 718-960-9900

Email: jonathan.schwartz@perrigo.com

Results disclosure agreements

• Principal investigator is a sponsor employee PI's cannot disclose trial results under any circumstances.
• Publication restrictions are in place

Restriction type: OTHER