A Pilot Study on the Use of Seysara for Rosacea
Condition: Acne Rosacea
MeSH terms: Rosacea
Intervention: sarecycline; Centrum Adult Multivitamin
Intervention description: sarecycline tablet; Centrum Adult Mulltivitamin tablet
Intervention MeSH terms: Sarecycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a prospective, parallel group, randomized, investigator-blinded pilot study.
      Approximately 100 subjects will be randomized at a 3:1 ratio to Seysara (sarecycline) at a
      weight-based dose per label or Centrum Adult Multivitamin to take by mouth daily. The study
      is comprised of 5 visits: screening, baseline, week 4, week 8, and week 12. Investigators
      will perform rosacea IGA (Investigator Global Assessment,) inflammatory lesion count, record
      adverse events and con meds, and ask each subject to complete a DLQI (Dermatology Life
      Quality Index.)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female ≥18 years of age

          2. Moderate to severe rosacea (IGA score 3 or 4) on the proposed facial treatment area
             consisting of:

               1. At least 15 and not more than 50 facial papules and pustules, excluding lesions
                  involving the eyes and scalp

               2. No more than 2 nodules on the face

          3. Presence or history of erythema and/or flushing of the face

          4. 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

          5. 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

          6. 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

          7. Completed and signed an appropriately administered Informed Consent Form (ICF) prior
             to any study-related procedures -

        Exclusion Criteria:

          1. Woman who is pregnant, lactating, or planning to become pregnant during the study
             period

          2. presence of any skin condition on the face that would interfere with the diagnosis or
             assessment of rosacea

          3. Moderate or severe rhinophyma, dense telangiectasia (score 3, severe;) or plaque-like
             facial edema

          4. Excessive facial hair (eg, beards, sideburns, moustaches, etc) that would interfere
             with diagnosis or assessment of rosacea

          5. History of hypersensitivity or allergy to all tetracyclines, or to any other component
             of the formulation

          6. Patients with history of C-diff associated colitis, intracranial hypertension will be
             excluded

          7. Severe erythema, dryness, scaling, pruritis, stinging/burning, or edema

          8. 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)

          9. Initiation of use of estrogens or oral contraceptives less than 3 months prior to Day
             0/Baseline

         10. Use within 1 month prior to Day 0/Baseline of:

               1. 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

               2. 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.)

         11. Use within 2 weeks prior to Day 0/Baseline of:

               1. Topical corticosteroids

               2. Topical antibiotics

               3. Topical medications for rosacea (eg, metronidazole)

         12. Use of sauna during the 2 weeks prior to Day 0/Baseline and during the study

         13. Had wax epilation of the face within 2 weeks prior to Day 0/Baseline

         14. Active bacterial folliculitis

         15. 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

         16. Participation in activities that involve excessive or prolonged exposure to sunlight
             or weather extremes, such as wind or cold

         17. 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

         18. 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

         19. 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

         20. 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