Acne Vulgaris
Conditions
Keywords
acne
Brief summary
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
Interventions
DRUGSarecycline
1.5 mg/kg/day taken orally at the same time each day,
DRUGPlacebo
Placebo-matching sarecycline tablets taken orally at the same time each day.
Sponsors
Allergan
Almirall, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
9 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent or assent form * Male/female, 9 to 45 years of age, inclusive * Body weight between 33 and 136 kg, inclusive * Facial acne vulgaris with: * 20-50 inflammatory lesions (papules, pustules and nodules) 30-100 noninflammatory lesions (open and closed comedones) * No more than 2 nodules * IGA score of moderate (3) or severe (4) * Negative urine pregnancy test at baseline - females of childbearing potential * Agrees to use an effective method of contraception throughout the study * Refrain from use of any other acne medications and medicated cleansers, and avoid excessive sun exposure and tanning booths for duration of study * Able to fulfill the requirements of protocol, indicated willingness to participate in the study and agrees to all study procedures (including mandatory photography) by providing written informed consent/assent and an authorization to disclose protected health information (PHI)
Exclusion criteria
* Has a dermatological condition of the face that could interfere with the clinical evaluations * Has a history of any of the following: * Allergy to tetracycline-class antibiotics or to any ingredient in the study drug * Pseudomembranous colitis or antibiotic associated colitis * Treated for any type of cancer within the last 6 months * Has known resistance to other tetracyclines * Has received any of the following treatments within 12 weeks of screening: * Systemic retinoids * Systemic corticosteroids * Androgens/anti-androgenic therapy (eg, anabolic steroids, spironolactone) * Non-medicated procedures for the treatment of acne (eg, laser, light or ThermaClear) * Has used any acne affecting treatment without an appropriate washout period * Has initiated hormonal contraceptive use within 12 weeks prior to screening or plans to initiate or switch hormonal contraceptive products during the study period * Is pregnant, lactating or planning a pregnancy during the study period * Has any other disorder causing hyperandrogenism including, but not limited to polycystic ovary syndrome, adrenal or ovarian tumors, Cushings disease or congenital adrenal hyperplasia * Has drug-induced acne * Has significant intercurrent illness, psychiatric disposition or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study * Is currently participating, or has participated within 30 days prior to the screening period in an investigational drug or device study * Has previously participated in any clinical trial involving the use of sarecycline * Is judged by the Investigator to be unsuitable for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in Facial Inflammatory Lesion Counts at Week 12 | Baseline (Day 1) to 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. |
| Percentage of Participants With Investigator Global Assement (IGA) Success at Week 12 | Baseline (Day 1) to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6 | Baseline (Day 1) to 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. |
| Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3 | Baseline (Day 1) to 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. |
| Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9 | Baseline (Day 1) to 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. |
| Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6 | Baseline (Day 1) to Weeks 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. |
| Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3 | Baseline (Day 1) to 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. |
| Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12 | Baseline (Day 1) to 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. |
| Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 | Baseline (Day 1) to 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. |
| Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6 | Baseline (Day 1) to 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. |
| Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3 | Baseline (Day 1) to 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. |
| Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12 | Baseline (Day 1) to 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. |
| Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9 | Baseline (Day 1) to 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. |
| Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6 | Baseline (Day 1) to 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. |
| Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3 | Baseline (Day 1) to 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. |
| Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9 | Baseline (Day 1) to 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. |
| Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9 | Baseline (Day 1) to 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sarecycline Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks. | 483 |
| Placebo Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks. | 485 |
| Total | 968 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 7 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 21 | 34 |
| Overall Study | Noncompliance with Study Treatment | 7 | 2 |
| Overall Study | Other Miscellaneous Reasons | 2 | 3 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal of Consent | 28 | 32 |
Baseline characteristics
| Characteristic | Sarecycline | Total | Placebo |
|---|---|---|---|
| Age, Customized ≥12 and <18 Years | 241 participants | 476 participants | 235 participants |
| Age, Customized ≥18 Years | 238 participants | 482 participants | 244 participants |
| Age, Customized ≥9 and <12 Years | 4 participants | 10 participants | 6 participants |
| Inflammatory Lesion Counts | 29.7 lesion count STANDARD_DEVIATION 8.7 | 30.0 lesion count STANDARD_DEVIATION 9.2 | 30.2 lesion count STANDARD_DEVIATION 9.6 |
| Investigator's Global Assessment (IGA) Score - Face | 3.1 score on a scale STANDARD_DEVIATION 0.4 | 3.1 score on a scale STANDARD_DEVIATION 0.4 | 3.2 score on a scale STANDARD_DEVIATION 0.4 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 5 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 11 Participants | 20 Participants | 9 Participants |
| Race/Ethnicity, Customized Black or African American | 80 Participants | 159 Participants | 79 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 144 Participants | 287 Participants | 143 Participants |
| Race/Ethnicity, Customized Multiple races | 11 Participants | 25 Participants | 14 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 2 Participants | 5 Participants | 3 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 339 Participants | 681 Participants | 342 Participants |
| Race/Ethnicity, Customized White | 377 Participants | 754 Participants | 377 Participants |
| Sex: Female, Male Female | 268 Participants | 539 Participants | 271 Participants |
| Sex: Female, Male Male | 215 Participants | 429 Participants | 214 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 481 | 0 / 483 |
| other Total, other adverse events | 0 / 481 | 0 / 483 |
| serious Total, serious adverse events | 3 / 481 | 5 / 483 |
Outcome results
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.
Time frame: Baseline (Day 1) to Week 12
Population: ITT population included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Absolute Change in Facial Inflammatory Lesion Counts at Week 12 | -15.3 lesion count | Standard Error 0.6 |
| Placebo | Absolute Change in Facial Inflammatory Lesion Counts at Week 12 | -10.1 lesion count | Standard Error 0.6 |
p-value: <0.000195% CI: [-6.7, -3.6]ANCOVA
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.
Time frame: Baseline (Day 1) to Week 12
Population: ITT population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sarecycline | Percentage of Participants With Investigator Global Assement (IGA) Success at Week 12 | 21.9 percentage of participants |
| Placebo | Percentage of Participants With Investigator Global Assement (IGA) Success at Week 12 | 10.5 percentage of participants |
p-value: <0.000195% CI: [6.39, 15.72]Cochran-Mantel-Haenszel
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.
Time frame: Baseline (Day 1) to Week 3
Population: ITT population included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3 | -8.5 lesion count | Standard Error 0.4 |
| Placebo | Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3 | -6.4 lesion count | Standard Error 0.4 |
Comparison: Change from Baseline to Week 3p-value: 0.000595% CI: [-3.3, -0.9]ANCOVA
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.
Time frame: Baseline (Day 1) to Weeks 6
Population: ITT population included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6 | -12.5 lesion count | Standard Error 0.5 |
| Placebo | Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6 | -8.4 lesion count | Standard Error 0.5 |
Comparison: Change from Baseline to Week 6p-value: <0.000195% CI: [-5.4, -2.9]ANCOVA
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.
Time frame: Baseline (Day 1) to Week 9
Population: ITT population included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9 | -13.9 lesion count | Standard Error 0.5 |
| Placebo | Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9 | -10.0 lesion count | Standard Error 0.5 |
Comparison: Change from Baseline to Week 9p-value: <0.000195% CI: [-5.3, -2.5]ANCOVA
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.
Time frame: Baseline (Day 1) to Week 12
Population: ITT population included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12 | -15.1 lesion count | Standard Error 0.9 |
| Placebo | Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12 | -11.2 lesion count | Standard Error 0.9 |
Comparison: Change from Baseline to Week 12p-value: 0.001495% CI: [-6.3, -1.5]ANCOVA
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.
Time frame: Baseline (Day 1) to Week 3
Population: ITT population included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3 | -7.9 lesion count | Standard Error 0.6 |
| Placebo | Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3 | -7.1 lesion count | Standard Error 0.6 |
Comparison: Change from Baseline to Week 3p-value: 0.380695% CI: [-2.5, 1]ANCOVA
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.
Time frame: Baseline (Day 1) to Week 6
Population: ITT population included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6 | -10.6 lesion count | Standard Error 0.7 |
| Placebo | Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6 | -8.6 lesion count | Standard Error 0.7 |
Comparison: Change from Baseline to Week 6p-value: 0.037195% CI: [-4, -0.1]ANCOVA
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.
Time frame: Baseline (Day 1) to Week 9
Population: ITT population included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9 | -13.0 lesion count | Standard Error 0.8 |
| Placebo | Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9 | -9.6 lesion count | Standard Error 0.8 |
Comparison: Change from Baseline to Week 9p-value: 0.00195% CI: [-5.5, -1.4]ANCOVA
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.
Time frame: Baseline (Day 1) to Week 12
Population: ITT population included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 | -51.8 percent change in lesion count | Standard Error 1.9 |
| Placebo | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 | -35.1 percent change in lesion count | Standard Error 2 |
Comparison: Percent Change from Baseline to Week 12p-value: <0.000195% CI: [-21.9, -11.6]ANCOVA
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.
Time frame: Baseline (Day 1) to Week 3
Population: ITT population included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3 | -29.6 percent change in lesion count | Standard Error 1.5 |
| Placebo | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3 | -22.4 percent change in lesion count | Standard Error 1.5 |
Comparison: Percent Change from Baseline to Week 3p-value: 0.000395% CI: [-11.1, -3.3]ANCOVA
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.
Time frame: Baseline (Day 1) to Week 6
Population: ITT population included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6 | -42.2 percent change in lesion count | Standard Error 1.6 |
| Placebo | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6 | -28.9 percent change in lesion count | Standard Error 1.6 |
Comparison: Percent Change from Baseline to Week 6p-value: <0.000195% CI: [-17.5, -9.1]ANCOVA
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.
Time frame: Baseline (Day 1) to Week 9
Population: ITT population included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9 | -47.4 percent change in lesion count | Standard Error 1.7 |
| Placebo | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9 | -34.9 percent change in lesion count | Standard Error 1.7 |
Comparison: Percent Change from Baseline to Week 9p-value: <0.000195% CI: [-16.9, -8]ANCOVA
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.
Time frame: Baseline (Day 1) to Week 12
Population: ITT population included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12 | -27.0 percent change in lesion count | Standard Error 5.6 |
| Placebo | Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12 | -22.7 percent change in lesion count | Standard Error 5.6 |
Comparison: Percent Change from Baseline to Week 12p-value: 0.578695% CI: [-19.4, 10.8]ANCOVA
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.
Time frame: Baseline (Day 1) to Week 3
Population: ITT population included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3 | -8.0 percent change in lesion count | Standard Error 4.4 |
| Placebo | Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3 | -14.3 percent change in lesion count | Standard Error 4.3 |
Comparison: Percent Change from Baseline to Week 3p-value: 0.286195% CI: [-5.3, 18.1]ANCOVA
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.
Time frame: Baseline (Day 1) to Week 6
Population: ITT population included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6 | -14.6 percent change in lesion count | Standard Error 6.6 |
| Placebo | Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6 | -17.6 percent change in lesion count | Standard Error 6.6 |
Comparison: Percent Change from Baseline to Week 6p-value: 0.737795% CI: [-14.7, 20.7]ANCOVA
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.
Time frame: Baseline (Day 1) to Week 9
Population: ITT population included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sarecycline | Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9 | -20.8 percent change in lesion count | Standard Error 5.3 |
| Placebo | Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9 | -18.0 percent change in lesion count | Standard Error 5.3 |
Comparison: Percent Change from Baseline to Week 9p-value: 0.696995% CI: [-17.1, 11.4]ANCOVA