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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.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sarecycline | Experimental | weight-based dose per label by mouth once daily for 12 weeks |
|
| Centrum Adult Multivitamin | Other | one tablet by mouth daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sarecycline | Drug | sarecycline tablet |
|
|
| 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 |
| 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) |
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Inclusion Criteria:
Male or female ≥18 years of age
Moderate to severe rosacea (IGA score 3 or 4) on the proposed facial treatment area consisting of:
Presence or history of erythema and/or flushing of the face
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
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
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
Completed and signed an appropriately administered Informed Consent Form (ICF) prior to any study-related procedures -
Exclusion Criteria:
Woman who is pregnant, lactating, or planning to become pregnant during the study period
presence of any skin condition on the face that would interfere with the diagnosis or assessment of rosacea
Moderate or severe rhinophyma, dense telangiectasia (score 3, severe;) or plaque-like facial edema
Excessive facial hair (eg, beards, sideburns, moustaches, etc) that would interfere with diagnosis or assessment of rosacea
History of hypersensitivity or allergy to all tetracyclines, or to any other component of the formulation
Patients with history of C-diff associated colitis, intracranial hypertension will be excluded
Severe erythema, dryness, scaling, pruritis, stinging/burning, or edema
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)
Initiation of use of estrogens or oral contraceptives less than 3 months prior to Day 0/Baseline
Use within 1 month prior to Day 0/Baseline of:
Use within 2 weeks prior to Day 0/Baseline of:
Use of sauna during the 2 weeks prior to Day 0/Baseline and during the study
Had wax epilation of the face within 2 weeks prior to Day 0/Baseline
Active bacterial folliculitis
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
Participation in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold
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
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
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
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Sciences, PLLC | Louisville | Kentucky | 40217 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sarecycline | weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet |
| FG001 | Centrum Adult Multivitamin | one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sarecycline | weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet |
| BG001 | Centrum Adult Multivitamin | one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Count of Participants | Participants | 12 weeks |
|
12 weeks average, from signing of Informed Consent until end of study participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sarecycline | weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Boil | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senen Pena | Skin Sciences, PLLC | 502-451-9000 | spdermresearch@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2019 | Apr 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000629276 | sarecycline |
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| Centrum Adult Multivitamin | Dietary Supplement | Centrum Adult Mulltivitamin tablet |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
one tablet by mouth daily for 12 weeks
Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet
|
|
| Primary | Inflammatory Lesion Count | Change in inflammatory lesion count | Posted | Mean | Standard Deviation | Percent Change | Baseline and 12 weeks |
|
|
|
| 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) | Posted | Count of Participants | Participants | week 4 |
|
|
|
| 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) | Posted | Count of Participants | Participants | week 8 |
|
|
|
| Secondary | Inflammatory Lesion Count | Change in inflammatory lesion count | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 4 |
|
|
|
| Secondary | Inflammatory Lesion Count | Change in inflammatory lesion count | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 8 |
|
|
|
| 0 |
| 72 |
| 0 |
| 72 |
| 16 |
| 72 |
| EG001 | Centrum Adult Multivitamin | one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet | 0 | 25 | 0 | 25 | 0 | 25 |
| bone spur | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| cholecystectomy | Surgical and medical procedures | Systematic Assessment |
|
| cholelithiasis worsening | Hepatobiliary disorders | Systematic Assessment |
|
| dry lips | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| facial sunburn | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| dog bite r arm | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
|
| generalized muscle soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| herpes simplex l lower lip | Infections and infestations | Systematic Assessment |
|
| influenza | Infections and infestations | Systematic Assessment |
|
| ingrown eyebrow hair | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| intermittent pain under r rib cage | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| metallic taste | Gastrointestinal disorders | Systematic Assessment |
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| nausea | Gastrointestinal disorders | Systematic Assessment |
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| r ear infection | Ear and labyrinth disorders | Systematic Assessment |
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| rash of unknown origin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| respiratory syncytial virus | Infections and infestations | Systematic Assessment |
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| sinus infection | Infections and infestations | Systematic Assessment |
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| sleep apnea | Nervous system disorders | Systematic Assessment |
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| stomach bloating | Gastrointestinal disorders | Systematic Assessment |
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| sunburn on face | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| tinea versicolor | Infections and infestations | Systematic Assessment |
|
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