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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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To evaluate the efficacy and safety of an approximate 1.5mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sarecycline | Experimental | Sarecycline tablets, 1.5 milligram(mg)/kilogram(kg)/day, taken orally once daily for 12 weeks. |
|
| Placebo | Placebo Comparator | Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sarecycline | Drug | 1.5 mg/kg/day taken orally at the same time each day, |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Facial Inflammatory Lesion Counts at Week 12 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on Analysis of Covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | Baseline (Day 1) to Week 12 |
| Percentage of Participants With Investigator Global Assement (IGA) Success at Week 12 | The investigator assessed the participant's inflammatory lesions on the face using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). The percentage of participants who achieved success is reported. | Baseline (Day 1) to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Kaoukhov, MD | Warner Chilcott, an Affiliate of Allergan plc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warner Chilcott Research Site (Site #155) | Beverly Hills | California | 90210 | United States | ||
| Warner Chilcott Research Site (Site #129) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sarecycline | Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks. |
| FG001 | Placebo | Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 16, 2015 | Apr 17, 2018 |
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| Placebo |
| Drug |
Placebo-matching sarecycline tablets taken orally at the same time each day. |
|
| Baseline (Day 1) to Week 12 |
| Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | Baseline (Day 1) to Week 9 |
| Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | Baseline (Day 1) to Week 6 |
| Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | Baseline (Day 1) to Week 3 |
| Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | Baseline (Day 1) to Week 9 |
| Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | Baseline (Day 1) to Weeks 6 |
| Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | Baseline (Day 1) to Week 3 |
| Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | Baseline (Day 1) to Week 12 |
| Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | Baseline (Day 1) to Week 9 |
| Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | Baseline (Day 1) to Week 6 |
| Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | Baseline (Day 1) to Week 3 |
| Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | Baseline (Day 1) to Week 12 |
| Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | Baseline (Day 1) to Week 9 |
| Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | Baseline (Day 1) to Week 6 |
| Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | Baseline (Day 1) to Week 3 |
| Encino |
| California |
| 91436 |
| United States |
| Warner Chilcott Research Site (Site #150) | La Mesa | California | 91942 | United States |
| Warner Chilcott Research Site (Site #136) | Los Angeles | California | 90045 | United States |
| Warner Chilcott Research Site (Site #147) | Sacramento | California | 95819 | United States |
| Warner Chilcott Research Site (Site #123) | San Diego | California | 92117 | United States |
| Warner Chilcott Research Site (Site #125) | San Diego | California | 92123 | United States |
| Warner Chilcott Research Site (Site #139) | Santa Rosa | California | 95403 | United States |
| Warner Chilcott Research Site (Site #157) | Tustin | California | 92780 | United States |
| Warner Chilcott Research Site (Site #122) | Denver | Colorado | 80209 | United States |
| Warner Chilcott Research Site (Site #148) | Wheat Ridge | Colorado | 80033 | United States |
| Warner Chilcott Research Site (Site #133) | New Haven | Connecticut | 06511 | United States |
| Warner Chilcott Research Site (Site #130) | Boca Raton | Florida | 33486 | United States |
| Warner Chilcott Research Site (Site #152) | Boynton Beach | Florida | 33437 | United States |
| Warner Chilcott Research Site (Site #102) | Miami | Florida | 33025 | United States |
| Warner Chilcott Research Site (Site #145) | Miami | Florida | 33175 | United States |
| Warner Chilcott Research Site (Site #140) | North Miami Beach | Florida | 33162 | United States |
| Warner Chilcott Research Site (Site #151) | Orange Park | Florida | 32073 | United States |
| Warner Chilcott Research Site (Site #108) | Sanford | Florida | 32771 | United States |
| Warner Chilcott Research Site (Site #110) | West Palm Beach | Florida | 33409 | United States |
| Warner Chilcott Research Site (Site #154) | Atlanta | Georgia | 30328 | United States |
| Warner Chilcott Research Site (Site #120) | Augusta | Georgia | 30909 | United States |
| Warner Chilcott Research Site (Site #124) | Boise | Idaho | 83704 | United States |
| Warner Chilcott Research Site (Site #106) | Chicago | Illinois | 60611 | United States |
| Warner Chilcott Research Site (Site #112) | Plainfield | Indiana | 46168 | United States |
| Warner Chilcott Research Site (Site #113) | South Bend | Indiana | 46617 | United States |
| Warner Chilcott Research Site (Site #117) | Louisville | Kentucky | 40217 | United States |
| Warner Chilcott Research Site (Site #135) | Lake Charles | Louisiana | 70605 | United States |
| Warner Chilcott Research Site (Site #153) | Metairie | Louisiana | 70006 | United States |
| Warner Chilcott Research Site (Site #137) | Detroit | Michigan | 48202 | United States |
| Warner Chilcott Research Site (Site #111) | Warren | Michigan | 48088 | United States |
| Warner Chilcott Research Site (Site #119) | St Louis | Missouri | 63117 | United States |
| Warner Chilcott Research Site (Site #138) | Omaha | Nebraska | 68114 | United States |
| Warner Chilcott Research Site (Site #103) | Henderson | Nevada | 89074 | United States |
| Warner Chilcott Research Site (Site #127) | Verona | New Jersey | 07044 | United States |
| Warner Chilcott Research Site (Site #146) | New York | New York | 10016 | United States |
| Warner Chilcott Research Site (Site #132) | New York | New York | 10075 | United States |
| Warner Chilcott Research Site (Site #134) | Smithtown | New York | 11787 | United States |
| Warner Chilcott Research Site (Site #107) | High Point | North Carolina | 27262 | United States |
| Warner Chilcott Research Site (Site #126) | Cincinnati | Ohio | 45249 | United States |
| Warner Chilcott Research Site (Site #143) | Warren | Ohio | 44483 | United States |
| Warner Chilcott Research Site (Site #149) | Gresham | Oregon | 97030 | United States |
| Warner Chilcott Research Site (Site #131) | Portland | Oregon | 97210 | United States |
| Warner Chilcott Research Site (Site #114) | Greer | South Carolina | 29650 | United States |
| Warner Chilcott Research Site (Site #128) | Knoxville | Tennessee | 37917 | United States |
| Warner Chilcott Research Site (Site #109) | Nashville | Tennessee | 37215 | United States |
| Warner Chilcott Research Site (Site #116) | Austin | Texas | 78759 | United States |
| Warner Chilcott Research Site (Site #104) | Dallas | Texas | 75234 | United States |
| Warner Chilcott Research Site (Site #115) | El Paso | Texas | 79902 | United States |
| Warner Chilcott Research Site (Site #142) | Houston | Texas | 77004 | United States |
| Warner Chilcott Research Site (Site #105) | Houston | Texas | 77056 | United States |
| Warner Chilcott Research Site (Site #101) | Plano | Texas | 75093 | United States |
| Warner Chilcott Research Site (Site #118) | San Antonio | Texas | 78229 | United States |
| Warner Chilcott Research Site (Site #156) | Layton | Utah | 84041 | United States |
| Warner Chilcott Research Site (Site #141) | Salt Lake City | Utah | 84117 | United States |
| Warner Chilcott Research Site (Site #121) | Charlottesville | Virginia | 22911 | United States |
| Warner Chilcott Research Site (Site #144) | Spokane | Washington | 99204 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat (ITT) Population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sarecycline | Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks. |
| BG001 | Placebo | Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Inflammatory Lesion Counts | Facial area lesion counts were made at forehead, left and right cheeks, nose, and chin. Inflammatory lesion counts were defined as: papule: a solid, elevated lesion <0.5 cm in diameter with surrounding erythematous halo; pustule: an elevated lesion containing pus <0.5 cm in diameter with surrounding erythematous halo; nodule: palpable solid erythematous lesion >0.5 cm in diameter; has depth, not necessarily elevated. | Mean | Standard Deviation | lesion count |
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| Investigator's Global Assessment (IGA) Score - Face | The investigator assessed the participant's inflammatory lesions on the face using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. | Mean | Standard Deviation | score on a scale |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Absolute Change in Facial Inflammatory Lesion Counts at Week 12 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on Analysis of Covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | ITT population included all randomized participants. | Posted | Least Squares Mean | Standard Error | lesion count | Baseline (Day 1) to Week 12 |
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| Primary | Percentage of Participants With Investigator Global Assement (IGA) Success at Week 12 | The investigator assessed the participant's inflammatory lesions on the face using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). The percentage of participants who achieved success is reported. | ITT population included all randomized participants. | Posted | Number | percentage of participants | Baseline (Day 1) to Week 12 |
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| Secondary | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | ITT population included all randomized participants. | Posted | Least Squares Mean | Standard Error | percent change in lesion count | Baseline (Day 1) to Week 12 |
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| Secondary | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | ITT population included all randomized participants. | Posted | Least Squares Mean | Standard Error | percent change in lesion count | Baseline (Day 1) to Week 9 |
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| Secondary | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | ITT population included all randomized participants. | Posted | Least Squares Mean | Standard Error | percent change in lesion count | Baseline (Day 1) to Week 6 |
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| Secondary | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | ITT population included all randomized participants. | Posted | Least Squares Mean | Standard Error | percent change in lesion count | Baseline (Day 1) to Week 3 |
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| Secondary | Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | ITT population included all randomized participants. | Posted | Least Squares Mean | Standard Error | lesion count | Baseline (Day 1) to Week 9 |
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| Secondary | Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | ITT population included all randomized participants. | Posted | Least Squares Mean | Standard Error | lesion count | Baseline (Day 1) to Weeks 6 |
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| Secondary | Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | ITT population included all randomized participants. | Posted | Least Squares Mean | Standard Error | lesion count | Baseline (Day 1) to Week 3 |
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| Secondary | Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | ITT population included all randomized participants. | Posted | Least Squares Mean | Standard Error | percent change in lesion count | Baseline (Day 1) to Week 12 |
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| Secondary | Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | ITT population included all randomized participants. | Posted | Least Squares Mean | Standard Error | percent change in lesion count | Baseline (Day 1) to Week 9 |
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| Secondary | Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | ITT population included all randomized participants. | Posted | Least Squares Mean | Standard Error | percent change in lesion count | Baseline (Day 1) to Week 6 |
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| Secondary | Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | ITT population included all randomized participants. | Posted | Least Squares Mean | Standard Error | percent change in lesion count | Baseline (Day 1) to Week 3 |
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| Secondary | Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | ITT population included all randomized participants. | Posted | Least Squares Mean | Standard Error | lesion count | Baseline (Day 1) to Week 12 |
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| Secondary | Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | ITT population included all randomized participants. | Posted | Least Squares Mean | Standard Error | lesion count | Baseline (Day 1) to Week 9 |
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| Secondary | Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | ITT population included all randomized participants. | Posted | Least Squares Mean | Standard Error | lesion count | Baseline (Day 1) to Week 6 |
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| Secondary | Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3 | Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate. | ITT population included all randomized participants. | Posted | Least Squares Mean | Standard Error | lesion count | Baseline (Day 1) to Week 3 |
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Up to 20.7 Weeks
The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sarecycline | Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks. | 0 | 481 | 3 | 481 | 0 | 481 |
| EG001 | Placebo | Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks. | 0 | 483 | 5 | 483 | 0 | 483 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA, Version 19.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA, Version 19.1 | Systematic Assessment |
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| Miscarriage of partner | Social circumstances | MedDRA, Version 19.1 | Systematic Assessment |
|
Not provided
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2017 | Apr 17, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629276 | sarecycline |
Not provided
Not provided
Not provided
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| ≥18 Years |
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| Native Hawaiian or other Pacific Islander |
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| Multiple races |
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| Not Hispanic or Latino |
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