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

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

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

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Sarecycline; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1034
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Warner Chilcott Research Site (Site #206)
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Warner Chilcott Research Site (Site #236)
  • California
    • Carlsbad, California, United States, 92008
      • Warner Chilcott Research Site (Site #245)
    • Encinitas, California, United States, 92024
      • Warner Chilcott Research Site (Site #234)
    • Fremont, California, United States, 94538
      • Warner Chilcott Research Site (Site #209)
    • Oceanside, California, United States, 92056
      • Warner Chilcott Research Site (Site #215)
    • San Diego, California, United States, 92123
      • Warner Chilcott Research Site (Site #204)
    • San Diego, California, United States, 92123
      • Warner Chilcott Research Site (Site #254)
    • Santa Ana, California, United States, 92701
      • Warner Chilcott Research Site (Site #257)
    • Santa Monica, California, United States, 90404
      • Warner Chilcott Research Site (Site #243)
  • Colorado
    • Denver, Colorado, United States, 80220
      • Warner Chilcott Research Site (Site #222)
  • Florida
    • Aventura, Florida, United States, 33180
      • Warner Chilcott Research Site (Site #237)
    • Clearwater, Florida, United States, 33761
      • Warner Chilcott Research Site (Site #226)
    • Jupiter, Florida, United States, 33458
      • Warner Chilcott Research Site (Site #238)
    • Lauderdale Lakes, Florida, United States, 33319
      • Warner Chilcott Research Site (Site #255)
    • Miami, Florida, United States, 33142
      • Warner Chilcott Research Site (Site #249)
    • Miami, Florida, United States, 33144
      • Warner Chilcott Research Site (Site #202)
    • Miramar, Florida, United States, 33027
      • Warner Chilcott Research Site (Site #211)
    • Ocala, Florida, United States, 34471
      • Warner Chilcott Research Site (Site #247)
    • Orlando, Florida, United States, 32806
      • Warner Chilcott Research Site (Site #241)
    • Pinellas Park, Florida, United States, 33781
      • Warner Chilcott Research Site (Site #228)
    • Tampa, Florida, United States, 33609
      • Warner Chilcott Research Site (Site #203)
  • Georgia
    • Snellville, Georgia, United States, 30078
      • Warner Chilcott Research Site (Site #242)
  • Illinois
    • Champaign, Illinois, United States, 61820
      • Warner Chilcott Research Site (Site #210)
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Warner Chilcott Research Site (Site #213)
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Warner Chilcott Research Site (Site #217)
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • Warner Chilcott Research Site (Site #248)
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Warner Chilcott Research Site (Site #205)
    • Clarkston, Michigan, United States, 48346
      • Warner Chilcott Research Site (Site #251)
    • Clinton Township, Michigan, United States, 48038
      • Warner Chilcott Research Site (Site #235)
    • Fort Gratiot, Michigan, United States, 48059
      • Warner Chilcott Research Site (Site #227)
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Warner Chilcott Research Site (Site #221)
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Warner Chilcott Research Site (Site #231)
  • New Hampshire
    • Newington, New Hampshire, United States, 03801
      • Warner Chilcott Research Site (Site #253)
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Warner Chilcott Research Site (Site #239)
  • New York
    • New York, New York, United States, 10155
      • Warner Chilcott Research Site (Site #208)
    • Rochester, New York, United States, 14623
      • Warner Chilcott Research Site (Site #240)
    • Stony Brook, New York, United States, 11790
      • Warner Chilcott Research Site (Site #230)
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Warner Chilcott Research Site (Site #229)
    • Wilmington, North Carolina, United States, 28405
      • Warner Chilcott Research Site (Site #250)
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Warner Chilcott Research Site (Site #218)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Warner Chilcott Research Site (Site #256)
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Warner Chilcott Research Site (Site #214)
  • South Carolina
    • Fountain Inn, South Carolina, United States, 29644
      • Warner Chilcott Research Site (Site #219)
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Warner Chilcott Research Site (Site #225)
    • Knoxville, Tennessee, United States, 37922
      • Warner Chilcott Research Site (Site #216)
  • Texas
    • Arlington, Texas, United States, 76011
      • Warner Chilcott Research Site (Site #252)
    • College Station, Texas, United States, 77845
      • Warner Chilcott Research Site (Site #220)
    • Katy, Texas, United States, 77494
      • Warner Chilcott Research Site (Site #201)
    • Pflugerville, Texas, United States, 78660
      • Warner Chilcott Research Site (Site #223)
    • San Antonio, Texas, United States, 78218
      • Warner Chilcott Research Site (Site #207)
    • Webster, Texas, United States, 77598
      • Warner Chilcott Research Site (Site #224)
  • Utah
    • West Jordan, Utah, United States, 84088
      • Warner Chilcott Research Site (Site #212)
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Warner Chilcott Research Site (Site #244)
  • Washington
    • Seattle, Washington, United States, 98105
      • Warner Chilcott Research Site (Site #246)
    • Walla Walla, Washington, United States, 99362
      • Warner Chilcott Research Site (Site #233)
  • Wisconsin
    • Madison, Wisconsin, United States, 53719
      • Warner Chilcott Research Site (Site #232)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 43 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Almirall, S.A.
• Collaborators: Allergan
• Investigators: Study Director: David Berk, MD, Allergan, plc

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2014
• Primary Completion (Actual): January 12, 2017
• Study Completion (Actual): January 12, 2017

Study Registration Dates

• First Submitted: December 15, 2014
• First Submitted That Met QC Criteria: December 22, 2014
• First Posted (Estimate): December 23, 2014

Study Record Updates

• Last Update Posted (Actual): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: acne
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Anti-Infective Agents; Dermatologic Agents; Anti-Bacterial Agents; Sarecycline
• Other Study ID Numbers: SC1402