Trial Outcomes & Findings for A Pilot Study on the Use of Seysara for Rosacea (NCT NCT04555525)

Last Updated: 2021-01-07

Results Overview

Percent of subjects achieving clear or almost clear on IGA. The Investigator will score rosacea at each visit as per the following IGA: 0 = Clear (No inflammatory lesions present, no erythema); 1 = Almost Clear (Very few small papules/pustules, very mild erythema present); 2 Mild (Few small or large papules/pustules, moderate erythema); 3= Moderate (Several small or large papules/pustules, moderate erythema); 4 = Severe (Numerous small and/or large papules/pustules, severe erythema)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

12 weeks

Results posted on

2021-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	Sarecycline weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet	Centrum Adult Multivitamin one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet
Overall Study STARTED	75	25
Overall Study COMPLETED	72	25
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study on the Use of Seysara for Rosacea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sarecycline n=72 Participants weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet	Centrum Adult Multivitamin n=25 Participants one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet	Total n=97 Participants Total of all reporting groups
Age, Continuous	52.42 years STANDARD_DEVIATION 14.96 • n=5 Participants	52.36 years STANDARD_DEVIATION 13.47 • n=7 Participants	52.41 years STANDARD_DEVIATION 14.52 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	22 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	3 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	69 Participants n=5 Participants	25 Participants n=7 Participants	94 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	72 participants n=5 Participants	25 participants n=7 Participants	97 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Sarecycline n=72 Participants weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet	Centrum Adult Multivitamin n=25 Participants one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet
IGA (Investigator Global Assessment)	54 Participants	4 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Change in inflammatory lesion count

Outcome measures

Outcome measures
Measure	Sarecycline n=72 Participants weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet	Centrum Adult Multivitamin n=25 Participants one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet
Inflammatory Lesion Count	-80 Percent Change Standard Deviation 24	-60 Percent Change Standard Deviation 32

SECONDARY outcome

Timeframe: week 4

Outcome measures

Outcome measures
Measure	Sarecycline n=72 Participants weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet	Centrum Adult Multivitamin n=25 Participants one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet
IGA	15 Participants	2 Participants

SECONDARY outcome

Timeframe: week 8

Outcome measures

Outcome measures
Measure	Sarecycline n=72 Participants weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet	Centrum Adult Multivitamin n=25 Participants one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet
IGA	32 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline and Week 4

Change in inflammatory lesion count

Outcome measures

Outcome measures
Measure	Sarecycline n=72 Participants weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet	Centrum Adult Multivitamin n=25 Participants one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet
Inflammatory Lesion Count	-56 Percent Change Standard Deviation 29	-31 Percent Change Standard Deviation 30

SECONDARY outcome

Timeframe: Baseline and Week 8

Change in inflammatory lesion count

Outcome measures

Outcome measures
Measure	Sarecycline n=72 Participants weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet	Centrum Adult Multivitamin n=25 Participants one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet
Inflammatory Lesion Count	-71 Percent Change Standard Deviation 27	-44 Percent Change Standard Deviation 42

Adverse Events

Sarecycline

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Centrum Adult Multivitamin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Senen Pena

Skin Sciences, PLLC

Phone: 502-451-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Sarecycline n=72 participants at risk weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet	Centrum Adult Multivitamin n=25 participants at risk one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet
Skin and subcutaneous tissue disorders Boil	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Musculoskeletal and connective tissue disorders bone spur	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Surgical and medical procedures cholecystectomy	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Hepatobiliary disorders cholelithiasis worsening	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Skin and subcutaneous tissue disorders dry lips	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Skin and subcutaneous tissue disorders facial sunburn	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Skin and subcutaneous tissue disorders dog bite r arm	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Gastrointestinal disorders gastroenteritis	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Musculoskeletal and connective tissue disorders generalized muscle soreness	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Nervous system disorders headache	2.8% 2/72 • Number of events 2 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Infections and infestations herpes simplex l lower lip	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Infections and infestations influenza	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Skin and subcutaneous tissue disorders ingrown eyebrow hair	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Musculoskeletal and connective tissue disorders intermittent pain under r rib cage	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Gastrointestinal disorders metallic taste	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Gastrointestinal disorders nausea	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Ear and labyrinth disorders r ear infection	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Skin and subcutaneous tissue disorders rash of unknown origin	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Infections and infestations respiratory syncytial virus	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Infections and infestations sinus infection	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Nervous system disorders sleep apnea	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Gastrointestinal disorders stomach bloating	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Skin and subcutaneous tissue disorders sunburn on face	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.
Infections and infestations tinea versicolor	1.4% 1/72 • Number of events 1 • 12 weeks average, from signing of Informed Consent until end of study participation.	0.00% 0/25 • 12 weeks average, from signing of Informed Consent until end of study participation.