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

• 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: Almirall, S.A.
• Collaborator: Allergan
• Information provided by (Responsible Party): Almirall, S.A.

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

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: Sarecycline; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 968 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 18, 2014
• Actual Primary Completion Date: February 1, 2017
• Actual Study Completion Date: February 1, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sarecycline; Sarecycline tablets, 1.5 milligram(mg)/kilogram(kg)/day, taken orally once daily for 12 weeks.	Drug: Sarecycline; 1.5 mg/kg/day taken orally at the same time each day,
Placebo Comparator: Placebo; Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.	Drug: Placebo; Placebo-matching sarecycline tablets taken orally at the same time each day.

Outcome Measures

Primary Outcome Measures :

1. Absolute Change in Facial Inflammatory Lesion Counts at Week 12 [ Time Frame: Baseline (Day 1) to Week 12 ]
   Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on Analysis of Covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
2. Percentage of Participants With Investigator Global Assement (IGA) Success at Week 12 [ Time Frame: Baseline (Day 1) to Week 12 ]
   The investigator assessed the participant's inflammatory lesions on the face using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). The percentage of participants who achieved success is reported.

Secondary Outcome Measures :

1. Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 [ Time Frame: Baseline (Day 1) to Week 12 ]
   Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
2. Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9 [ Time Frame: Baseline (Day 1) to Week 9 ]
   Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
3. Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6 [ Time Frame: Baseline (Day 1) to Week 6 ]
   Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
4. Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3 [ Time Frame: Baseline (Day 1) to Week 3 ]
   Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
5. Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9 [ Time Frame: Baseline (Day 1) to Week 9 ]
   Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
6. Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6 [ Time Frame: Baseline (Day 1) to Weeks 6 ]
   Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
7. Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3 [ Time Frame: Baseline (Day 1) to Week 3 ]
   Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
8. Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12 [ Time Frame: Baseline (Day 1) to Week 12 ]
   Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
9. Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9 [ Time Frame: Baseline (Day 1) to Week 9 ]
   Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
10. Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6 [ Time Frame: Baseline (Day 1) to Week 6 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
11. Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3 [ Time Frame: Baseline (Day 1) to Week 3 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
12. Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12 [ Time Frame: Baseline (Day 1) to Week 12 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
13. Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9 [ Time Frame: Baseline (Day 1) to Week 9 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
14. Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6 [ Time Frame: Baseline (Day 1) to Week 6 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
15. Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3 [ Time Frame: Baseline (Day 1) to Week 3 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

Eligibility Criteria

• Ages Eligible for Study: 9 Years to 45 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

  Hide Study Locations

Locations

United States, California

Warner Chilcott Research Site (Site #155)

Beverly Hills, California, United States, 90210

Warner Chilcott Research Site (Site #129)

Encino, California, United States, 91436

Warner Chilcott Research Site (Site #150)

La Mesa, California, United States, 91942

Warner Chilcott Research Site (Site #136)

Los Angeles, California, United States, 90045

Warner Chilcott Research Site (Site #147)

Sacramento, California, United States, 95819

Warner Chilcott Research Site (Site #123)

San Diego, California, United States, 92117

Warner Chilcott Research Site (Site #125)

San Diego, California, United States, 92123

Warner Chilcott Research Site (Site #139)

Santa Rosa, California, United States, 95403

Warner Chilcott Research Site (Site #157)

Tustin, California, United States, 92780

United States, Colorado

Warner Chilcott Research Site (Site #122)

Denver, Colorado, United States, 80209

Warner Chilcott Research Site (Site #148)

Wheat Ridge, Colorado, United States, 80033

United States, Connecticut

Warner Chilcott Research Site (Site #133)

New Haven, Connecticut, United States, 06511

United States, Florida

Warner Chilcott Research Site (Site #130)

Boca Raton, Florida, United States, 33486

Warner Chilcott Research Site (Site #152)

Boynton Beach, Florida, United States, 33437

Warner Chilcott Research Site (Site #102)

Miami, Florida, United States, 33025

Warner Chilcott Research Site (Site #145)

Miami, Florida, United States, 33175

Warner Chilcott Research Site (Site #140)

North Miami Beach, Florida, United States, 33162

Warner Chilcott Research Site (Site #151)

Orange Park, Florida, United States, 32073

Warner Chilcott Research Site (Site #108)

Sanford, Florida, United States, 32771

Warner Chilcott Research Site (Site #110)

West Palm Beach, Florida, United States, 33409

United States, Georgia

Warner Chilcott Research Site (Site #154)

Atlanta, Georgia, United States, 30328

Warner Chilcott Research Site (Site #120)

Augusta, Georgia, United States, 30909

United States, Idaho

Warner Chilcott Research Site (Site #124)

Boise, Idaho, United States, 83704

United States, Illinois

Warner Chilcott Research Site (Site #106)

Chicago, Illinois, United States, 60611

United States, Indiana

Warner Chilcott Research Site (Site #112)

Plainfield, Indiana, United States, 46168

Warner Chilcott Research Site (Site #113)

South Bend, Indiana, United States, 46617

United States, Kentucky

Warner Chilcott Research Site (Site #117)

Louisville, Kentucky, United States, 40217

United States, Louisiana

Warner Chilcott Research Site (Site #135)

Lake Charles, Louisiana, United States, 70605

Warner Chilcott Research Site (Site #153)

Metairie, Louisiana, United States, 70006

United States, Michigan

Warner Chilcott Research Site (Site #137)

Detroit, Michigan, United States, 48202

Warner Chilcott Research Site (Site #111)

Warren, Michigan, United States, 48088

United States, Missouri

Warner Chilcott Research Site (Site #119)

Saint Louis, Missouri, United States, 63117

United States, Nebraska

Warner Chilcott Research Site (Site #138)

Omaha, Nebraska, United States, 68114

United States, Nevada

Warner Chilcott Research Site (Site #103)

Henderson, Nevada, United States, 89074

United States, New Jersey

Warner Chilcott Research Site (Site #127)

Verona, New Jersey, United States, 07044

United States, New York

Warner Chilcott Research Site (Site #146)

New York, New York, United States, 10016

Warner Chilcott Research Site (Site #132)

New York, New York, United States, 10075

Warner Chilcott Research Site (Site #134)

Smithtown, New York, United States, 11787

United States, North Carolina

Warner Chilcott Research Site (Site #107)

High Point, North Carolina, United States, 27262

United States, Ohio

Warner Chilcott Research Site (Site #126)

Cincinnati, Ohio, United States, 45249

Warner Chilcott Research Site (Site #143)

Warren, Ohio, United States, 44483

United States, Oregon

Warner Chilcott Research Site (Site #149)

Gresham, Oregon, United States, 97030

Warner Chilcott Research Site (Site #131)

Portland, Oregon, United States, 97210

United States, South Carolina

Warner Chilcott Research Site (Site #114)

Greer, South Carolina, United States, 29650

United States, Tennessee

Warner Chilcott Research Site (Site #128)

Knoxville, Tennessee, United States, 37917

Warner Chilcott Research Site (Site #109)

Nashville, Tennessee, United States, 37215

United States, Texas

Warner Chilcott Research Site (Site #116)

Austin, Texas, United States, 78759

Warner Chilcott Research Site (Site #104)

Dallas, Texas, United States, 75234

Warner Chilcott Research Site (Site #115)

El Paso, Texas, United States, 79902

Warner Chilcott Research Site (Site #142)

Houston, Texas, United States, 77004

Warner Chilcott Research Site (Site #105)

Houston, Texas, United States, 77056

Warner Chilcott Research Site (Site #101)

Plano, Texas, United States, 75093

Warner Chilcott Research Site (Site #118)

San Antonio, Texas, United States, 78229

United States, Utah

Warner Chilcott Research Site (Site #156)

Layton, Utah, United States, 84041

Warner Chilcott Research Site (Site #141)

Salt Lake City, Utah, United States, 84117

United States, Virginia

Warner Chilcott Research Site (Site #121)

Charlottesville, Virginia, United States, 22911

United States, Washington

Warner Chilcott Research Site (Site #144)

Spokane, Washington, United States, 99204

Sponsors and Collaborators

Almirall, S.A.

Allergan

Investigators

• Study Director: Alexandre Kaoukhov, MD; Warner Chilcott, an Affiliate of Allergan plc

  Study Documents (Full-Text)

Documents provided by Almirall, S.A.:

Study Protocol  [PDF] December 16, 2015

Statistical Analysis Plan  [PDF] March 3, 2017

More Information

• Responsible Party: Almirall, S.A.
• ClinicalTrials.gov Identifier: NCT02320149 History of Changes
• Obsolete Identifiers: NCT02651012
• Other Study ID Numbers: SC1401
• First Posted: December 19, 2014
• Results First Posted: May 17, 2018
• Last Update Posted: February 15, 2019
• Last Verified: January 2019

Keywords provided by Almirall, S.A.:

acne

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Sarecycline; Anti-Bacterial Agents; Anti-Infective Agents; Dermatologic Agents