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Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

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ClinicalTrials.gov Identifier: NCT02320149
Recruitment Status : Completed
First Posted : December 19, 2014
Results First Posted : May 17, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Almirall, S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Sarecycline
Drug: Placebo
Enrollment 968
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks. Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Period Title: Overall Study
Started 483 485
Completed 420 405
Not Completed 63 80
Reason Not Completed
Adverse Event             3             7
Withdrawal of Consent             28             32
Lost to Follow-up             21             34
Protocol Violation             2             1
Noncompliance with Study Treatment             7             2
Lack of Efficacy             0             1
Other Miscellaneous Reasons             2             3
Arm/Group Title Sarecycline Placebo Total
Hide Arm/Group Description Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks. Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 483 485 968
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) Population included all randomized participants.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 483 participants 485 participants 968 participants
≥9 and <12 Years 4 6 10
≥12 and <18 Years 241 235 476
≥18 Years 238 244 482
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 483 participants 485 participants 968 participants
Female
268
  55.5%
271
  55.9%
539
  55.7%
Male
215
  44.5%
214
  44.1%
429
  44.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 483 participants 485 participants 968 participants
White 377 377 754
Black or African American 80 79 159
Asian 11 9 20
American Indian or Alaska Native 2 3 5
Native Hawaiian or other Pacific Islander 2 3 5
Multiple races 11 14 25
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 483 participants 485 participants 968 participants
Hispanic or Latino 144 143 287
Not Hispanic or Latino 339 342 681
Inflammatory Lesion Counts   [1] 
Mean (Standard Deviation)
Unit of measure:  Lesion count
Number Analyzed 483 participants 485 participants 968 participants
29.7  (8.7) 30.2  (9.6) 30.0  (9.2)
[1]
Measure Description: 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.
Investigator’s Global Assessment (IGA) Score - Face   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 483 participants 485 participants 968 participants
3.1  (0.4) 3.2  (0.4) 3.1  (0.4)
[1]
Measure Description: 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.
1.Primary Outcome
Title Absolute Change in Facial Inflammatory Lesion Counts at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description:
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 483 485
Least Squares Mean (Standard Error)
Unit of Measure: lesion count
-15.3  (0.6) -10.1  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sarecycline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -5.2
Confidence Interval (2-Sided) 95%
-6.7 to -3.6
Estimation Comments sarecycline - placebo
2.Primary Outcome
Title Percentage of Participants With Investigator Global Assement (IGA) Success at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description:
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 483 485
Measure Type: Number
Unit of Measure: percentage of participants
21.9 10.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sarecycline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-values were based on the test of general association between the response and treatment group using Cochran-Mantel-Haenszel test with pooled site as stratification factor.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Rate Difference
Estimated Value 11.05
Confidence Interval (2-Sided) 95%
6.39 to 15.72
Estimation Comments sarecycline - placebo
3.Secondary Outcome
Title Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description:
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 483 485
Least Squares Mean (Standard Error)
Unit of Measure: percent change in lesion count
-51.8  (1.9) -35.1  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sarecycline, Placebo
Comments Percent Change from Baseline to Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -16.7
Confidence Interval (2-Sided) 95%
-21.9 to -11.6
Estimation Comments sarecycline - placebo
4.Secondary Outcome
Title Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description:
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 483 485
Least Squares Mean (Standard Error)
Unit of Measure: percent change in lesion count
-47.4  (1.7) -34.9  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sarecycline, Placebo
Comments Percent Change from Baseline to Week 9
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -12.5
Confidence Interval 95%
-16.9 to -8.0
Estimation Comments sarecycline - placebo
5.Secondary Outcome
Title Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description:
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 483 485
Least Squares Mean (Standard Error)
Unit of Measure: percent change in lesion count
-42.2  (1.6) -28.9  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sarecycline, Placebo
Comments Percent Change from Baseline to Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -13.3
Confidence Interval (2-Sided) 95%
-17.5 to -9.1
Estimation Comments sarecycline - placebo
6.Secondary Outcome
Title Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description:
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 483 485
Least Squares Mean (Standard Error)
Unit of Measure: percent change in lesion count
-29.6  (1.5) -22.4  (1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sarecycline, Placebo
Comments Percent Change from Baseline to Week 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -7.2
Confidence Interval (2-Sided) 95%
-11.1 to -3.3
Estimation Comments sarecycline - placebo
7.Secondary Outcome
Title Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description:
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 483 485
Least Squares Mean (Standard Error)
Unit of Measure: lesion count
-13.9  (0.5) -10.0  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sarecycline, Placebo
Comments Change from Baseline to Week 9
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-5.3 to -2.5
Estimation Comments sarecycline - placebo
8.Secondary Outcome
Title Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description:
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 483 485
Least Squares Mean (Standard Error)
Unit of Measure: lesion count
-12.5  (0.5) -8.4  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sarecycline, Placebo
Comments Change from Baseline to Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -4.1
Confidence Interval (2-Sided) 95%
-5.4 to -2.9
Estimation Comments sarecycline - placebo
9.Secondary Outcome
Title Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description:
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 483 485
Least Squares Mean (Standard Error)
Unit of Measure: lesion count
-8.5  (0.4) -6.4  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sarecycline, Placebo
Comments Change from Baseline to Week 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-3.3 to -0.9
Estimation Comments sarecycline - placebo
10.Secondary Outcome
Title Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description:
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 483 485
Least Squares Mean (Standard Error)
Unit of Measure: percent change in lesion count
-27.0  (5.6) -22.7  (5.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sarecycline, Placebo
Comments Percent Change from Baseline to Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5786
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -4.3
Confidence Interval (2-Sided) 95%
-19.4 to 10.8
Estimation Comments sarecycline - placebo
11.Secondary Outcome
Title Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description:
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 483 485
Least Squares Mean (Standard Error)
Unit of Measure: percent change in lesion count
-20.8  (5.3) -18.0  (5.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sarecycline, Placebo
Comments Percent Change from Baseline to Week 9
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6969
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-17.1 to 11.4
Estimation Comments sarecycline - placebo
12.Secondary Outcome
Title Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description:
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 483 485
Least Squares Mean (Standard Error)
Unit of Measure: percent change in lesion count
-14.6  (6.6) -17.6  (6.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sarecycline, Placebo
Comments Percent Change from Baseline to Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7377
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
-14.7 to 20.7
Estimation Comments sarecycline - placebo
13.Secondary Outcome
Title Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description:
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 483 485
Least Squares Mean (Standard Error)
Unit of Measure: percent change in lesion count
-8.0  (4.4) -14.3  (4.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sarecycline, Placebo
Comments Percent Change from Baseline to Week 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2861
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 6.4
Confidence Interval (2-Sided) 95%
-5.3 to 18.1
Estimation Comments sarecycline - placebo
14.Secondary Outcome
Title Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description:
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 483 485
Least Squares Mean (Standard Error)
Unit of Measure: lesion count
-15.1  (0.9) -11.2  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sarecycline, Placebo
Comments Change from Baseline to Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-6.3 to -1.5
Estimation Comments sarecycline - placebo
15.Secondary Outcome
Title Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description:
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 483 485
Least Squares Mean (Standard Error)
Unit of Measure: lesion count
-13.0  (0.8) -9.6  (0.8)
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Statistical Analysis Overview Comparison Group Selection Sarecycline, Placebo
Comments Change from Baseline to Week 9
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -3.4
Confidence Interval (2-Sided) 95%
-5.5 to -1.4
Estimation Comments sarecycline - placebo
16.Secondary Outcome
Title Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description:
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 483 485
Least Squares Mean (Standard Error)
Unit of Measure: lesion count
-10.6  (0.7) -8.6  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sarecycline, Placebo
Comments Change from Baseline to Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0371
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-4.0 to -0.1
Estimation Comments sarecycline - placebo
17.Secondary Outcome
Title Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description:
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 483 485
Least Squares Mean (Standard Error)
Unit of Measure: lesion count
-7.9  (0.6) -7.1  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sarecycline, Placebo
Comments Change from Baseline to Week 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3806
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-2.5 to 1.0
Estimation Comments sarecycline - placebo
Time Frame Up to 20.7 Weeks
Adverse Event Reporting Description 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.
 
Arm/Group Title Sarecycline Placebo
Hide Arm/Group Description Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks. Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
All-Cause Mortality
Sarecycline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/481 (0.00%)   0/483 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Sarecycline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3/481 (0.62%)   5/483 (1.04%) 
Infections and infestations     
Appendicitis  1  0/481 (0.00%)  1/483 (0.21%) 
Cellulitis  1  0/481 (0.00%)  1/483 (0.21%) 
Investigations     
Alanine aminotransferase increased  1  1/481 (0.21%)  0/483 (0.00%) 
Aspartate aminotransferase increased  1  1/481 (0.21%)  0/483 (0.00%) 
Gamma-glutamyltransferase increased  1  1/481 (0.21%)  0/483 (0.00%) 
Metabolism and nutrition disorders     
Diabetic ketoacidosis  1  1/481 (0.21%)  0/483 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  0/481 (0.00%)  2/483 (0.41%) 
Psychiatric disorders     
Suicide attempt  1  0/481 (0.00%)  1/483 (0.21%) 
Renal and urinary disorders     
Nephrolithiasis  1  1/481 (0.21%)  0/483 (0.00%) 
Social circumstances     
Miscarriage of partner  1  0/481 (0.00%)  1/483 (0.21%) 
1
Term from vocabulary, MedDRA, Version 19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sarecycline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/481 (0.00%)   0/483 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT02320149     History of Changes
Obsolete Identifiers: NCT02651012
Other Study ID Numbers: SC1401
First Submitted: December 15, 2014
First Posted: December 19, 2014
Results First Submitted: April 17, 2018
Results First Posted: May 17, 2018
Last Update Posted: February 15, 2019