Intervention: Sarecycline
Trial phase: Phase 4
ATC code: J01AA14 | J01AA20
SMILES: [H][C@@]12Cc3c(CN(C)OC)ccc(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 72
Group description: weight-based dose per label by mouth once daily for 12 weeks

sarecycline: sarecycline tablet
Eligibility criteria:
Inclusion Criteria:

Male or female ≥18 years of age

Moderate to severe rosacea (IGA score 3 or 4) on the proposed facial treatment area consisting of:

At least 15 and not more than 50 facial papules and pustules, excluding lesions involving the eyes and scalp
No more than 2 nodules on the face
Presence or history of erythema and/or flushing of the face
If a female of child-bearing potential, have a negative urine pregnancy test and agree to use an effective method of contraception. A sterile sexual partner is NOT considered an adequate form of birth control
Willing to minimize external factors that might trigger rosacea flare-ups (eg, spicy foods, thermally hot foods and drinks, hot environments, prolonged sun exposure, strong winds, and alcoholic beverages
Subjects who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to use the same make-up, brand/type, or frequency of use throughout the study
Completed and signed an appropriately administered Informed Consent Form (ICF) prior to any study-related procedures -

Exclusion Criteria:

Woman who is pregnant, lactating, or planning to become pregnant during the study period
presence of any skin condition on the face that would interfere with the diagnosis or assessment of rosacea
Moderate or severe rhinophyma, dense telangiectasia (score 3, severe;) or plaque-like facial edema
Excessive facial hair (eg, beards, sideburns, moustaches, etc) that would interfere with diagnosis or assessment of rosacea
History of hypersensitivity or allergy to all tetracyclines, or to any other component of the formulation
Patients with history of C-diff associated colitis, intracranial hypertension will be excluded
Severe erythema, dryness, scaling, pruritis, stinging/burning, or edema
Use within 6 months prior to Day 0/Baseline of oral retinoids (eg, Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed)
Initiation of use of estrogens or oral contraceptives less than 3 months prior to Day 0/Baseline

Use within 1 month prior to Day 0/Baseline of:

Systemic antibiotics known to have an impact on the severity of facial rosacea (eg, containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim.) Subjects requiring systemic antibiotics not known to affect rosacea will be considered on a case-by-case basis
Systemic corticosteroids (Note: intranasal and inhalational corticosteroids do not require a washout and maybe used throughout the trial if the subject is on a stable dose.)

Use within 2 weeks prior to Day 0/Baseline of:

Topical corticosteroids
Topical antibiotics
Topical medications for rosacea (eg, metronidazole)
Use of sauna during the 2 weeks prior to Day 0/Baseline and during the study
Had wax epilation of the face within 2 weeks prior to Day 0/Baseline
Active bacterial folliculitis
Consumption of excessive alcohol, abuse of licit or illicit drugs, or a condition that, in the opinion of the Investigator, could compromise the subject's ability to comply with study requirements
Participation in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold
Presence of any clinically significant condition or situation, other than the condition being studied, that in the opinion of the Investigator would interfere with the study evaluations or optimal participation in the study
Participation in an investigational drug study (ie, subject has been treated with an investigational drug) within 30 days prior to Day 0/Baseline. Subjects who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion
Prior laser therapy (for telangiectasia or other conditions), electrodessication, or phototherapy (eg, ClearLight ®) to the facial area within 180 days prior to Day 0/Baseline
Prior cosmetic procedures (eg, facials) that may affect the efficacy and safety profile of the investigational product within 14 days prior to Day 0/Baseline