A Pilot Study on the Use of Seysara for Rosacea

NCT ID: NCT04555525

Last Updated: 2021-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2020-10-01

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.)

Conditions

Acne Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

sarecycline

weight-based dose per label by mouth once daily for 12 weeks

Group Type: EXPERIMENTAL

sarecycline

Intervention Type: DRUG

sarecycline tablet

Centrum Adult Multivitamin

one tablet by mouth daily for 12 weeks

Group Type: OTHER

Centrum Adult Multivitamin

Intervention Type: DIETARY_SUPPLEMENT

Centrum Adult Mulltivitamin tablet

Interventions

sarecycline

sarecycline tablet

Intervention Type: DRUG

Centrum Adult Multivitamin

Centrum Adult Mulltivitamin tablet

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Seysara; sarecycline hydrochloride

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Derm Research, PLLC

OTHER

Sponsor Role: lead

Responsible Party

L.H. Kircik, M.D.

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Skin Sciences, PLLC

Louisville, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SEY1901

Identifier Type: -

Identifier Source: org_study_id