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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320149
• Other study ID #: SC1401
• Status: Completed
• Phase: Phase 3
• Start date: December 18, 2014
• Est. completion date: February 1, 2017

Study information

• Verified date: January 2019
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Other known NCT identifiers

• NCT02651012

Recruitment information / eligibility

• Status: Completed
• Enrollment: 968
• Est. completion date: February 1, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Sarecycline
1.5 mg/kg/day taken orally at the same time each day,
• Placebo
Placebo-matching sarecycline tablets taken orally at the same time each day.

Locations

Country	Name	City	State
United States	Warner Chilcott Research Site (Site #154)	Atlanta	Georgia
United States	Warner Chilcott Research Site (Site #120)	Augusta	Georgia
United States	Warner Chilcott Research Site (Site #116)	Austin	Texas
United States	Warner Chilcott Research Site (Site #155)	Beverly Hills	California
United States	Warner Chilcott Research Site (Site #130)	Boca Raton	Florida
United States	Warner Chilcott Research Site (Site #124)	Boise	Idaho
United States	Warner Chilcott Research Site (Site #152)	Boynton Beach	Florida
United States	Warner Chilcott Research Site (Site #121)	Charlottesville	Virginia
United States	Warner Chilcott Research Site (Site #106)	Chicago	Illinois
United States	Warner Chilcott Research Site (Site #126)	Cincinnati	Ohio
United States	Warner Chilcott Research Site (Site #104)	Dallas	Texas
United States	Warner Chilcott Research Site (Site #122)	Denver	Colorado
United States	Warner Chilcott Research Site (Site #137)	Detroit	Michigan
United States	Warner Chilcott Research Site (Site #115)	El Paso	Texas
United States	Warner Chilcott Research Site (Site #129)	Encino	California
United States	Warner Chilcott Research Site (Site #114)	Greer	South Carolina
United States	Warner Chilcott Research Site (Site #149)	Gresham	Oregon
United States	Warner Chilcott Research Site (Site #103)	Henderson	Nevada
United States	Warner Chilcott Research Site (Site #107)	High Point	North Carolina
United States	Warner Chilcott Research Site (Site #105)	Houston	Texas
United States	Warner Chilcott Research Site (Site #142)	Houston	Texas
United States	Warner Chilcott Research Site (Site #128)	Knoxville	Tennessee
United States	Warner Chilcott Research Site (Site #150)	La Mesa	California
United States	Warner Chilcott Research Site (Site #135)	Lake Charles	Louisiana
United States	Warner Chilcott Research Site (Site #156)	Layton	Utah
United States	Warner Chilcott Research Site (Site #136)	Los Angeles	California
United States	Warner Chilcott Research Site (Site #117)	Louisville	Kentucky
United States	Warner Chilcott Research Site (Site #153)	Metairie	Louisiana
United States	Warner Chilcott Research Site (Site #102)	Miami	Florida
United States	Warner Chilcott Research Site (Site #145)	Miami	Florida
United States	Warner Chilcott Research Site (Site #109)	Nashville	Tennessee
United States	Warner Chilcott Research Site (Site #133)	New Haven	Connecticut
United States	Warner Chilcott Research Site (Site #132)	New York	New York
United States	Warner Chilcott Research Site (Site #146)	New York	New York
United States	Warner Chilcott Research Site (Site #140)	North Miami Beach	Florida
United States	Warner Chilcott Research Site (Site #138)	Omaha	Nebraska
United States	Warner Chilcott Research Site (Site #151)	Orange Park	Florida
United States	Warner Chilcott Research Site (Site #112)	Plainfield	Indiana
United States	Warner Chilcott Research Site (Site #101)	Plano	Texas
United States	Warner Chilcott Research Site (Site #131)	Portland	Oregon
United States	Warner Chilcott Research Site (Site #147)	Sacramento	California
United States	Warner Chilcott Research Site (Site #119)	Saint Louis	Missouri
United States	Warner Chilcott Research Site (Site #141)	Salt Lake City	Utah
United States	Warner Chilcott Research Site (Site #118)	San Antonio	Texas
United States	Warner Chilcott Research Site (Site #123)	San Diego	California
United States	Warner Chilcott Research Site (Site #125)	San Diego	California
United States	Warner Chilcott Research Site (Site #108)	Sanford	Florida
United States	Warner Chilcott Research Site (Site #139)	Santa Rosa	California
United States	Warner Chilcott Research Site (Site #134)	Smithtown	New York
United States	Warner Chilcott Research Site (Site #113)	South Bend	Indiana
United States	Warner Chilcott Research Site (Site #144)	Spokane	Washington
United States	Warner Chilcott Research Site (Site #157)	Tustin	California
United States	Warner Chilcott Research Site (Site #127)	Verona	New Jersey
United States	Warner Chilcott Research Site (Site #111)	Warren	Michigan
United States	Warner Chilcott Research Site (Site #143)	Warren	Ohio
United States	Warner Chilcott Research Site (Site #110)	West Palm Beach	Florida
United States	Warner Chilcott Research Site (Site #148)	Wheat Ridge	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Almirall, S.A.	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change in Facial Inflammatory Lesion Counts at Week 12	Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on Analysis of Covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.	Baseline (Day 1) to Week 12
Primary	Percentage of Participants With Investigator Global Assement (IGA) Success at Week 12	The investigator assessed the participant's inflammatory lesions on the face using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). The percentage of participants who achieved success is reported.	Baseline (Day 1) to Week 12
Secondary	Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12	Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.	Baseline (Day 1) to Week 12
Secondary	Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9	Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.	Baseline (Day 1) to Week 9
Secondary	Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6	Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.	Baseline (Day 1) to Week 6
Secondary	Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3	Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.	Baseline (Day 1) to Week 3
Secondary	Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9	Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.	Baseline (Day 1) to Week 9
Secondary	Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6	Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.	Baseline (Day 1) to Weeks 6
Secondary	Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3	Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.	Baseline (Day 1) to Week 3
Secondary	Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12	Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.	Baseline (Day 1) to Week 12
Secondary	Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9	Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.	Baseline (Day 1) to Week 9
Secondary	Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6	Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.	Baseline (Day 1) to Week 6
Secondary	Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3	Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.	Baseline (Day 1) to Week 3
Secondary	Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12	Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.	Baseline (Day 1) to Week 12
Secondary	Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9	Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.	Baseline (Day 1) to Week 9
Secondary	Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6	Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.	Baseline (Day 1) to Week 6
Secondary	Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3	Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.	Baseline (Day 1) to Week 3