Acne Rosacea
Conditions
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.)
Interventions
DRUGsarecycline
sarecycline tablet
DIETARY_SUPPLEMENTCentrum Adult Multivitamin
Centrum Adult Mulltivitamin tablet
Sponsors
Derm Research, PLLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IGA (Investigator Global Assessment) | 12 weeks | 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) |
| Inflammatory Lesion Count | Baseline and 12 weeks | Change in inflammatory lesion count |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IGA | week 4 | 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) |
| Inflammatory Lesion Count | Baseline and Week 4 | Change in inflammatory lesion count |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sarecycline weight-based dose per label by mouth once daily for 12 weeks
sarecycline: sarecycline tablet | 72 |
| Centrum Adult Multivitamin one tablet by mouth daily for 12 weeks
Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet | 25 |
| Total | 97 |
Baseline characteristics
| Characteristic | Sarecycline | Total | Centrum Adult Multivitamin |
|---|---|---|---|
| Age, Continuous | 52.42 years STANDARD_DEVIATION 14.96 | 52.41 years STANDARD_DEVIATION 14.52 | 52.36 years STANDARD_DEVIATION 13.47 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 69 Participants | 94 Participants | 25 Participants |
| Region of Enrollment United States | 72 participants | 97 participants | 25 participants |
| Sex: Female, Male Female | 58 Participants | 80 Participants | 22 Participants |
| Sex: Female, Male Male | 14 Participants | 17 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 25 |
| other Total, other adverse events | 16 / 72 | 0 / 25 |
| serious Total, serious adverse events | 0 / 72 | 0 / 25 |
Outcome results
Primary
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)
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sarecycline | IGA (Investigator Global Assessment) | 54 Participants |
| Centrum Adult Multivitamin | IGA (Investigator Global Assessment) | 4 Participants |
Primary
Inflammatory Lesion Count
Change in inflammatory lesion count
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Inflammatory Lesion Count | -80 Percent Change | Standard Deviation 24 |
| Centrum Adult Multivitamin | Inflammatory Lesion Count | -60 Percent Change | Standard Deviation 32 |
Secondary
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)
Time frame: week 4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sarecycline | IGA | 15 Participants |
| Centrum Adult Multivitamin | IGA | 2 Participants |
Secondary
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)
Time frame: week 8
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sarecycline | IGA | 32 Participants |
| Centrum Adult Multivitamin | IGA | 3 Participants |
Secondary
Inflammatory Lesion Count
Change in inflammatory lesion count
Time frame: Baseline and Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Inflammatory Lesion Count | -56 Percent Change | Standard Deviation 29 |
| Centrum Adult Multivitamin | Inflammatory Lesion Count | -31 Percent Change | Standard Deviation 30 |
Secondary
Inflammatory Lesion Count
Change in inflammatory lesion count
Time frame: Baseline and Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Inflammatory Lesion Count | -71 Percent Change | Standard Deviation 27 |
| Centrum Adult Multivitamin | Inflammatory Lesion Count | -44 Percent Change | Standard Deviation 42 |