A Pilot Study on the Use of Seysara for Rosacea

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.)

Study Overview

• Status: Completed
• Conditions: Acne Rosacea
• Intervention / Treatment: Drug: sarecycline; Dietary supplement: Centrum Adult Multivitamin

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Skin Sciences, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sarecycline; weight-based dose per label by mouth once daily for 12 weeks	Drug: sarecycline; sarecycline tablet; Other Names: Seysara; sarecycline hydrochloride
Other: Centrum Adult Multivitamin; one tablet by mouth daily for 12 weeks	Dietary supplement: Centrum Adult Multivitamin; Centrum Adult Mulltivitamin tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IGA (Investigator Global Assessment)	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)	12 weeks
Inflammatory Lesion Count	Change in inflammatory lesion count	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IGA	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)	week 4
IGA	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)	week 8
Inflammatory Lesion Count	Change in inflammatory lesion count	Baseline and Week 4
Inflammatory Lesion Count	Change in inflammatory lesion count	Baseline and Week 8

Collaborators and Investigators

• Sponsor: Derm Research, PLLC

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): September 23, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 7, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Anti-Infective Agents; Dermatologic Agents; Anti-Bacterial Agents; Sarecycline
• Other Study ID Numbers: SEY1901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes