Clinical trial NCT04555525: A Pilot Study on the Use of Seysara for Rosacea
Official title: A Pilot Study on the Use of Seysara for Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Rosacea
Lead sponsor: Derm Research, PLLC
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: IGA (Investigator Global Assessment)
timeFrame: 12 weeks
measure: Inflammatory Lesion Count
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: IGA
timeFrame: week 4
measure: IGA
timeFrame: week 8
measure: Inflammatory Lesion Count
timeFrame: Baseline and Week 4
measure: Inflammatory Lesion Count
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Skin Sciences, PLLC
state: Kentucky
Study officials:
References: