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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

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
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

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 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 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.

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. 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 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.

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.

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.

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.

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.

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.

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.

Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9

Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6

Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3

Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12

Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9

Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6

Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3

Full Information

NCT ID

NCT02320149

First Posted

December 15, 2014

Last Updated

January 31, 2019

Sponsor

Almirall, S.A.

Collaborators

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT02320149

Brief Title

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

Official Title

A Randomized, Multicenter, Double-blind, Placebocontrolled 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 18, 2014 (Actual)

Primary Completion Date

February 1, 2017 (Actual)

Study Completion Date

February 1, 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

5. Study Description

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

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

968 (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 in Facial Inflammatory Lesion Counts at Week 12

Description

Time Frame

Baseline (Day 1) to Week 12

Title

Percentage of Participants With Investigator Global Assement (IGA) Success at Week 12

Description

Time Frame

Baseline (Day 1) to 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. 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

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. 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

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. 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

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. 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

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. 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

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. 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

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. 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

Title

Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12

Description

Time Frame

Baseline (Day 1) to Week 12

Title

Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9

Description

Time Frame

Baseline (Day 1) to Week 9

Title

Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6

Description

Time Frame

Baseline (Day 1) to Week 6

Title

Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3

Description

Time Frame

Baseline (Day 1) to Week 3

Title

Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12

Description

Time Frame

Baseline (Day 1) to Week 12

Title

Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9

Description

Time Frame

Baseline (Day 1) to Week 9

Title

Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6

Description

Time Frame

Baseline (Day 1) to Week 6

Title

Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3

Description

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

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexandre Kaoukhov, MD

Organizational Affiliation

Warner Chilcott, an Affiliate of Allergan plc

Official's Role

Study Director

Facility Information:

Facility Name

Warner Chilcott Research Site (Site #155)

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90210

Country

United States

Facility Name

Warner Chilcott Research Site (Site #129)

City

Encino

State/Province

California

ZIP/Postal Code

91436

Country

United States

Facility Name

Warner Chilcott Research Site (Site #150)

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Warner Chilcott Research Site (Site #136)

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

Warner Chilcott Research Site (Site #147)

City

Sacramento

State/Province

California

ZIP/Postal Code

95819

Country

United States

Facility Name

Warner Chilcott Research Site (Site #123)

City

San Diego

State/Province

California

ZIP/Postal Code

92117

Country

United States

Facility Name

Warner Chilcott Research Site (Site #125)

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Warner Chilcott Research Site (Site #139)

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95403

Country

United States

Facility Name

Warner Chilcott Research Site (Site #157)

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

Warner Chilcott Research Site (Site #122)

City

Denver

State/Province

Colorado

ZIP/Postal Code

80209

Country

United States

Facility Name

Warner Chilcott Research Site (Site #148)

City

Wheat Ridge

State/Province

Colorado

ZIP/Postal Code

80033

Country

United States

Facility Name

Warner Chilcott Research Site (Site #133)

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

Facility Name

Warner Chilcott Research Site (Site #130)

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Warner Chilcott Research Site (Site #152)

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33437

Country

United States

Facility Name

Warner Chilcott Research Site (Site #102)

City

Miami

State/Province

Florida

ZIP/Postal Code

33025

Country

United States

Facility Name

Warner Chilcott Research Site (Site #145)

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Facility Name

Warner Chilcott Research Site (Site #140)

City

North Miami Beach

State/Province

Florida

ZIP/Postal Code

33162

Country

United States

Facility Name

Warner Chilcott Research Site (Site #151)

City

Orange Park

State/Province

Florida

ZIP/Postal Code

32073

Country

United States

Facility Name

Warner Chilcott Research Site (Site #108)

City

Sanford

State/Province

Florida

ZIP/Postal Code

32771

Country

United States

Facility Name

Warner Chilcott Research Site (Site #110)

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33409

Country

United States

Facility Name

Warner Chilcott Research Site (Site #154)

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Warner Chilcott Research Site (Site #120)

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

Facility Name

Warner Chilcott Research Site (Site #124)

City

Boise

State/Province

Idaho

ZIP/Postal Code

83704

Country

United States

Facility Name

Warner Chilcott Research Site (Site #106)

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Warner Chilcott Research Site (Site #112)

City

Plainfield

State/Province

Indiana

ZIP/Postal Code

46168

Country

United States

Facility Name

Warner Chilcott Research Site (Site #113)

City

South Bend

State/Province

Indiana

ZIP/Postal Code

46617

Country

United States

Facility Name

Warner Chilcott Research Site (Site #117)

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

Facility Name

Warner Chilcott Research Site (Site #135)

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70605

Country

United States

Facility Name

Warner Chilcott Research Site (Site #153)

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Warner Chilcott Research Site (Site #137)

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Warner Chilcott Research Site (Site #111)

City

Warren

State/Province

Michigan

ZIP/Postal Code

48088

Country

United States

Facility Name

Warner Chilcott Research Site (Site #119)

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63117

Country

United States

Facility Name

Warner Chilcott Research Site (Site #138)

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Warner Chilcott Research Site (Site #103)

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89074

Country

United States

Facility Name

Warner Chilcott Research Site (Site #127)

City

Verona

State/Province

New Jersey

ZIP/Postal Code

07044

Country

United States

Facility Name

Warner Chilcott Research Site (Site #146)

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Warner Chilcott Research Site (Site #132)

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

Facility Name

Warner Chilcott Research Site (Site #134)

City

Smithtown

State/Province

New York

ZIP/Postal Code

11787

Country

United States

Facility Name

Warner Chilcott Research Site (Site #107)

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Warner Chilcott Research Site (Site #126)

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45249

Country

United States

Facility Name

Warner Chilcott Research Site (Site #143)

City

Warren

State/Province

Ohio

ZIP/Postal Code

44483

Country

United States

Facility Name

Warner Chilcott Research Site (Site #149)

City

Gresham

State/Province

Oregon

ZIP/Postal Code

97030

Country

United States

Facility Name

Warner Chilcott Research Site (Site #131)

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Warner Chilcott Research Site (Site #114)

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29650

Country

United States

Facility Name

Warner Chilcott Research Site (Site #128)

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37917

Country

United States

Facility Name

Warner Chilcott Research Site (Site #109)

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

Facility Name

Warner Chilcott Research Site (Site #116)

City

Austin

State/Province

Texas

ZIP/Postal Code

78759

Country

United States

Facility Name

Warner Chilcott Research Site (Site #104)

City

Dallas

State/Province

Texas

ZIP/Postal Code

75234

Country

United States

Facility Name

Warner Chilcott Research Site (Site #115)

City

El Paso

State/Province

Texas

ZIP/Postal Code

79902

Country

United States

Facility Name

Warner Chilcott Research Site (Site #142)

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

Warner Chilcott Research Site (Site #105)

City

Houston

State/Province

Texas

ZIP/Postal Code

77056

Country

United States

Facility Name

Warner Chilcott Research Site (Site #101)

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

Warner Chilcott Research Site (Site #118)

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Warner Chilcott Research Site (Site #156)

City

Layton

State/Province

Utah

ZIP/Postal Code

84041

Country

United States

Facility Name

Warner Chilcott Research Site (Site #141)

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84117

Country

United States

Facility Name

Warner Chilcott Research Site (Site #121)

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22911

Country

United States

Facility Name

Warner Chilcott Research Site (Site #144)

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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

Acne Vulgaris

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial