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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02322866
• Other study ID #: SC1402
• Status: Completed
• Phase: Phase 3
• Start date: December 3, 2014
• Est. completion date: January 12, 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 1.5 mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1034
• Est. completion date: January 12, 2017
• Est. primary completion date: January 12, 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

• 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.

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 #239)	Albuquerque	New Mexico
United States	Warner Chilcott Research Site (Site #252)	Arlington	Texas
United States	Warner Chilcott Research Site (Site #237)	Aventura	Florida
United States	Warner Chilcott Research Site (Site #205)	Bay City	Michigan
United States	Warner Chilcott Research Site (Site #218)	Beachwood	Ohio
United States	Warner Chilcott Research Site (Site #245)	Carlsbad	California
United States	Warner Chilcott Research Site (Site #210)	Champaign	Illinois
United States	Warner Chilcott Research Site (Site #251)	Clarkston	Michigan
United States	Warner Chilcott Research Site (Site #226)	Clearwater	Florida
United States	Warner Chilcott Research Site (Site #235)	Clinton Township	Michigan
United States	Warner Chilcott Research Site (Site #220)	College Station	Texas
United States	Warner Chilcott Research Site (Site #222)	Denver	Colorado
United States	Warner Chilcott Research Site (Site #234)	Encinitas	California
United States	Warner Chilcott Research Site (Site #227)	Fort Gratiot	Michigan
United States	Warner Chilcott Research Site (Site #219)	Fountain Inn	South Carolina
United States	Warner Chilcott Research Site (Site #209)	Fremont	California
United States	Warner Chilcott Research Site (Site #221)	Fridley	Minnesota
United States	Warner Chilcott Research Site (Site #225)	Goodlettsville	Tennessee
United States	Warner Chilcott Research Site (Site #236)	Hot Springs	Arkansas
United States	Warner Chilcott Research Site (Site #238)	Jupiter	Florida
United States	Warner Chilcott Research Site (Site #201)	Katy	Texas
United States	Warner Chilcott Research Site (Site #216)	Knoxville	Tennessee
United States	Warner Chilcott Research Site (Site #255)	Lauderdale Lakes	Florida
United States	Warner Chilcott Research Site (Site #213)	Louisville	Kentucky
United States	Warner Chilcott Research Site (Site #232)	Madison	Wisconsin
United States	Warner Chilcott Research Site (Site #202)	Miami	Florida
United States	Warner Chilcott Research Site (Site #249)	Miami	Florida
United States	Warner Chilcott Research Site (Site #211)	Miramar	Florida
United States	Warner Chilcott Research Site (Site #206)	Mobile	Alabama
United States	Warner Chilcott Research Site (Site #208)	New York	New York
United States	Warner Chilcott Research Site (Site #253)	Newington	New Hampshire
United States	Warner Chilcott Research Site (Site #244)	Norfolk	Virginia
United States	Warner Chilcott Research Site (Site #247)	Ocala	Florida
United States	Warner Chilcott Research Site (Site #215)	Oceanside	California
United States	Warner Chilcott Research Site (Site #231)	Omaha	Nebraska
United States	Warner Chilcott Research Site (Site #241)	Orlando	Florida
United States	Warner Chilcott Research Site (Site #223)	Pflugerville	Texas
United States	Warner Chilcott Research Site (Site #256)	Philadelphia	Pennsylvania
United States	Warner Chilcott Research Site (Site #228)	Pinellas Park	Florida
United States	Warner Chilcott Research Site (Site #229)	Raleigh	North Carolina
United States	Warner Chilcott Research Site (Site #240)	Rochester	New York
United States	Warner Chilcott Research Site (Site #217)	Rockville	Maryland
United States	Warner Chilcott Research Site (Site #207)	San Antonio	Texas
United States	Warner Chilcott Research Site (Site #204)	San Diego	California
United States	Warner Chilcott Research Site (Site #254)	San Diego	California
United States	Warner Chilcott Research Site (Site #257)	Santa Ana	California
United States	Warner Chilcott Research Site (Site #243)	Santa Monica	California
United States	Warner Chilcott Research Site (Site #246)	Seattle	Washington
United States	Warner Chilcott Research Site (Site #242)	Snellville	Georgia
United States	Warner Chilcott Research Site (Site #230)	Stony Brook	New York
United States	Warner Chilcott Research Site (Site #203)	Tampa	Florida
United States	Warner Chilcott Research Site (Site #233)	Walla Walla	Washington
United States	Warner Chilcott Research Site (Site #214)	Warwick	Rhode Island
United States	Warner Chilcott Research Site (Site #248)	Watertown	Massachusetts
United States	Warner Chilcott Research Site (Site #224)	Webster	Texas
United States	Warner Chilcott Research Site (Site #212)	West Jordan	Utah
United States	Warner Chilcott Research Site (Site #250)	Wilmington	North Carolina

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 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.	Baseline (Day 1) to Week 12
Primary	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.	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. 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.	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. 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.	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. 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.	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. 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.	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. 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.	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. 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.	Baseline (Day 1) to Week 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. 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.	Baseline (Day 1) to Week 3