search
Back to results

Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sarecycline
Placebo
Sponsored by
Almirall, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne

Eligibility Criteria

9 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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
  • Investigator's Global Assessment (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 receive 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.

Sites / Locations

  • Warner Chilcott Research Site (Site #206)
  • Warner Chilcott Research Site (Site #236)
  • Warner Chilcott Research Site (Site #245)
  • Warner Chilcott Research Site (Site #234)
  • Warner Chilcott Research Site (Site #209)
  • Warner Chilcott Research Site (Site #215)
  • Warner Chilcott Research Site (Site #204)
  • Warner Chilcott Research Site (Site #254)
  • Warner Chilcott Research Site (Site #257)
  • Warner Chilcott Research Site (Site #243)
  • Warner Chilcott Research Site (Site #222)
  • Warner Chilcott Research Site (Site #237)
  • Warner Chilcott Research Site (Site #226)
  • Warner Chilcott Research Site (Site #238)
  • Warner Chilcott Research Site (Site #255)
  • Warner Chilcott Research Site (Site #249)
  • Warner Chilcott Research Site (Site #202)
  • Warner Chilcott Research Site (Site #211)
  • Warner Chilcott Research Site (Site #247)
  • Warner Chilcott Research Site (Site #241)
  • Warner Chilcott Research Site (Site #228)
  • Warner Chilcott Research Site (Site #203)
  • Warner Chilcott Research Site (Site #242)
  • Warner Chilcott Research Site (Site #210)
  • Warner Chilcott Research Site (Site #213)
  • Warner Chilcott Research Site (Site #217)
  • Warner Chilcott Research Site (Site #248)
  • Warner Chilcott Research Site (Site #205)
  • Warner Chilcott Research Site (Site #251)
  • Warner Chilcott Research Site (Site #235)
  • Warner Chilcott Research Site (Site #227)
  • Warner Chilcott Research Site (Site #221)
  • Warner Chilcott Research Site (Site #231)
  • Warner Chilcott Research Site (Site #253)
  • Warner Chilcott Research Site (Site #239)
  • Warner Chilcott Research Site (Site #208)
  • Warner Chilcott Research Site (Site #240)
  • Warner Chilcott Research Site (Site #230)
  • Warner Chilcott Research Site (Site #229)
  • Warner Chilcott Research Site (Site #250)
  • Warner Chilcott Research Site (Site #218)
  • Warner Chilcott Research Site (Site #256)
  • Warner Chilcott Research Site (Site #214)
  • Warner Chilcott Research Site (Site #219)
  • Warner Chilcott Research Site (Site #225)
  • Warner Chilcott Research Site (Site #216)
  • Warner Chilcott Research Site (Site #252)
  • Warner Chilcott Research Site (Site #220)
  • Warner Chilcott Research Site (Site #201)
  • Warner Chilcott Research Site (Site #223)
  • Warner Chilcott Research Site (Site #207)
  • Warner Chilcott Research Site (Site #224)
  • Warner Chilcott Research Site (Site #212)
  • Warner Chilcott Research Site (Site #244)
  • Warner Chilcott Research Site (Site #246)
  • Warner Chilcott Research Site (Site #233)
  • Warner Chilcott Research Site (Site #232)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sarecycline

Placebo

Arm Description

Sarecycline tablets, 1.5 milligram(mg)/kilogram(kg)/day, taken orally once daily for 12 weeks.

Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.

Outcomes

Primary Outcome Measures

Absolute 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 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's Global Assessment (IGA) Scale 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. 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.

Secondary Outcome Measures

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. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 analysis of covariance (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
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 analysis of covariance (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 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. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 analysis of covariance (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
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 analysis of covariance (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
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 analysis of covariance (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
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 analysis of covariance (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
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

Full Information

First Posted
December 15, 2014
Last Updated
January 31, 2019
Sponsor
Almirall, S.A.
Collaborators
Allergan
search

1. Study Identification

Unique Protocol Identification Number
NCT02322866
Brief Title
Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne
Official Title
A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 1.5 mg/kg Per Day of Sarecycline Compared to Placebo in the Treatment of Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 3, 2014 (Actual)
Primary Completion Date
January 12, 2017 (Actual)
Study Completion Date
January 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Almirall, S.A.
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the efficacy and safety of an approximate 1.5 mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1034 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sarecycline
Arm Type
Experimental
Arm Description
Sarecycline tablets, 1.5 milligram(mg)/kilogram(kg)/day, taken orally once daily for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Sarecycline
Intervention Description
1.5 mg/kg/day taken orally at the same time each day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo-matching sarecycline tablets, taken orally at the same time each day.
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
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
Title
Percentage of Participants With Investigator's Global Assessment (IGA) Scale Success at Week 12
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. 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
Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
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. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 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
Title
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9
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. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 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 9
Title
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6
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. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 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 6
Title
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3
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. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 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 3
Title
Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9
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. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 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 9
Title
Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6
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. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 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 6
Title
Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3
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. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 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 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Investigator's Global Assessment (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 receive 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Berk, MD
Organizational Affiliation
Allergan, plc
Official's Role
Study Director
Facility Information:
Facility Name
Warner Chilcott Research Site (Site #206)
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Warner Chilcott Research Site (Site #236)
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Warner Chilcott Research Site (Site #245)
City
Carlsbad
State/Province
California
ZIP/Postal Code
92008
Country
United States
Facility Name
Warner Chilcott Research Site (Site #234)
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Warner Chilcott Research Site (Site #209)
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Warner Chilcott Research Site (Site #215)
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Warner Chilcott Research Site (Site #204)
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Warner Chilcott Research Site (Site #254)
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Warner Chilcott Research Site (Site #257)
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Warner Chilcott Research Site (Site #243)
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Warner Chilcott Research Site (Site #222)
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Warner Chilcott Research Site (Site #237)
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Warner Chilcott Research Site (Site #226)
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Warner Chilcott Research Site (Site #238)
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Warner Chilcott Research Site (Site #255)
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Warner Chilcott Research Site (Site #249)
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Warner Chilcott Research Site (Site #202)
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Warner Chilcott Research Site (Site #211)
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Warner Chilcott Research Site (Site #247)
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Warner Chilcott Research Site (Site #241)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Warner Chilcott Research Site (Site #228)
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Warner Chilcott Research Site (Site #203)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Warner Chilcott Research Site (Site #242)
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Warner Chilcott Research Site (Site #210)
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Warner Chilcott Research Site (Site #213)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Warner Chilcott Research Site (Site #217)
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Warner Chilcott Research Site (Site #248)
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Warner Chilcott Research Site (Site #205)
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Warner Chilcott Research Site (Site #251)
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Warner Chilcott Research Site (Site #235)
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Warner Chilcott Research Site (Site #227)
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Warner Chilcott Research Site (Site #221)
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Warner Chilcott Research Site (Site #231)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Warner Chilcott Research Site (Site #253)
City
Newington
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Warner Chilcott Research Site (Site #239)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Warner Chilcott Research Site (Site #208)
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
Warner Chilcott Research Site (Site #240)
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Warner Chilcott Research Site (Site #230)
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Warner Chilcott Research Site (Site #229)
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Warner Chilcott Research Site (Site #250)
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28405
Country
United States
Facility Name
Warner Chilcott Research Site (Site #218)
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Warner Chilcott Research Site (Site #256)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Warner Chilcott Research Site (Site #214)
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Warner Chilcott Research Site (Site #219)
City
Fountain Inn
State/Province
South Carolina
ZIP/Postal Code
29644
Country
United States
Facility Name
Warner Chilcott Research Site (Site #225)
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
Warner Chilcott Research Site (Site #216)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Warner Chilcott Research Site (Site #252)
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Warner Chilcott Research Site (Site #220)
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Warner Chilcott Research Site (Site #201)
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
Warner Chilcott Research Site (Site #223)
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Warner Chilcott Research Site (Site #207)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Warner Chilcott Research Site (Site #224)
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Warner Chilcott Research Site (Site #212)
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Warner Chilcott Research Site (Site #244)
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Warner Chilcott Research Site (Site #246)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Warner Chilcott Research Site (Site #233)
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Warner Chilcott Research Site (Site #232)
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

We'll reach out to this number within 24 hrs