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A Pilot Study on the Use of Seysara for Rosacea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04555525
Recruitment Status : Completed
First Posted : September 18, 2020
Results First Posted : December 16, 2020
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
L.H. Kircik, M.D., Derm Research, PLLC

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.)

Condition or disease Intervention/treatment Phase
Acne Rosacea Drug: sarecycline Dietary Supplement: Centrum Adult Multivitamin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study on the Use of Seysara for Rosacea
Actual Study Start Date : April 15, 2019
Actual Primary Completion Date : September 23, 2020
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

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

Centrum Adult Multivitamin
one tablet by mouth daily for 12 weeks
Dietary Supplement: Centrum Adult Multivitamin
Centrum Adult Mulltivitamin tablet




Primary Outcome Measures :
  1. IGA (Investigator Global Assessment) [ Time Frame: 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)


  2. Inflammatory Lesion Count [ Time Frame: Baseline and 12 weeks ]
    Change in inflammatory lesion count


Secondary Outcome Measures :
  1. IGA [ Time Frame: 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)


  2. IGA [ Time Frame: week 8 ]

    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)


  3. Inflammatory Lesion Count [ Time Frame: Baseline and Week 4 ]
    Change in inflammatory lesion count

  4. Inflammatory Lesion Count [ Time Frame: Baseline and Week 8 ]
    Change in inflammatory lesion count



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04555525


Locations
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United States, Kentucky
Skin Sciences, PLLC
Louisville, Kentucky, United States, 40217
Sponsors and Collaborators
Derm Research, PLLC
  Study Documents (Full-Text)

Documents provided by L.H. Kircik, M.D., Derm Research, PLLC:
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Responsible Party: L.H. Kircik, M.D., Medical Director, Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT04555525    
Other Study ID Numbers: SEY1901
First Posted: September 18, 2020    Key Record Dates
Results First Posted: December 16, 2020
Last Update Posted: January 7, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Rosacea
Skin Diseases
Sarecycline
Anti-Bacterial Agents
Anti-Infective Agents
Dermatologic Agents