Clinical trial NCT02322866: Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: acne
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
Collaborators: name: Allergan
First posted: 2014-12-23
Enrollment: 1034
Sex: ALL
Minimum age (years): 9
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


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
* 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.

Primary outcomes:
measure: Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
timeFrame: Baseline (Day 1) to Week 12
measure: Percentage of Participants With Investigator's Global Assessment (IGA) Scale Success at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
timeFrame: Baseline (Day 1) to Week 12
measure: Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9
timeFrame: Baseline (Day 1) to Week 9
measure: Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6
timeFrame: Baseline (Day 1) to Week 6
measure: Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3
timeFrame: Baseline (Day 1) to Week 3
measure: Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9
timeFrame: Baseline (Day 1) to Week 9
measure: Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6
timeFrame: Baseline (Day 1) to Week 6
measure: Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3
timeFrame: Baseline (Day 1) to Week 3
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Warner Chilcott Research Site (Site #206)
state: Alabama
city: Hot Springs
country: United States
facility: Warner Chilcott Research Site (Site #236)
state: Arkansas
city: Carlsbad
country: United States
facility: Warner Chilcott Research Site (Site #245)
state: California
city: Encinitas
country: United States
facility: Warner Chilcott Research Site (Site #234)
state: California
city: Fremont
country: United States
facility: Warner Chilcott Research Site (Site #209)
state: California
city: Oceanside
country: United States
facility: Warner Chilcott Research Site (Site #215)
state: California
city: San Diego
country: United States
facility: Warner Chilcott Research Site (Site #204)
state: California
city: San Diego
country: United States
facility: Warner Chilcott Research Site (Site #254)
state: California
city: Santa Ana
country: United States
facility: Warner Chilcott Research Site (Site #257)
state: California
city: Santa Monica
country: United States
facility: Warner Chilcott Research Site (Site #243)
state: California
city: Denver
country: United States
facility: Warner Chilcott Research Site (Site #222)
state: Colorado
city: Aventura
country: United States
facility: Warner Chilcott Research Site (Site #237)
state: Florida
city: Clearwater
country: United States
facility: Warner Chilcott Research Site (Site #226)
state: Florida
city: Jupiter
country: United States
facility: Warner Chilcott Research Site (Site #238)
state: Florida
city: Lauderdale Lakes
country: United States
facility: Warner Chilcott Research Site (Site #255)
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Research Site (Site #249)
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Research Site (Site #202)
state: Florida
city: Miramar
country: United States
facility: Warner Chilcott Research Site (Site #211)
state: Florida
city: Ocala
country: United States
facility: Warner Chilcott Research Site (Site #247)
state: Florida
city: Orlando
country: United States
facility: Warner Chilcott Research Site (Site #241)
state: Florida
city: Pinellas Park
country: United States
facility: Warner Chilcott Research Site (Site #228)
state: Florida
city: Tampa
country: United States
facility: Warner Chilcott Research Site (Site #203)
state: Florida
city: Snellville
country: United States
facility: Warner Chilcott Research Site (Site #242)
state: Georgia
city: Champaign
country: United States
facility: Warner Chilcott Research Site (Site #210)
state: Illinois
city: Louisville
country: United States
facility: Warner Chilcott Research Site (Site #213)
state: Kentucky
city: Rockville
country: United States
facility: Warner Chilcott Research Site (Site #217)
state: Maryland
city: Watertown
country: United States
facility: Warner Chilcott Research Site (Site #248)
state: Massachusetts
city: Bay City
country: United States
facility: Warner Chilcott Research Site (Site #205)
state: Michigan
city: Clarkston
country: United States
facility: Warner Chilcott Research Site (Site #251)
state: Michigan
city: Clinton Township
country: United States
facility: Warner Chilcott Research Site (Site #235)
state: Michigan
city: Fort Gratiot
country: United States
facility: Warner Chilcott Research Site (Site #227)
state: Michigan
city: Fridley
country: United States
facility: Warner Chilcott Research Site (Site #221)
state: Minnesota
city: Omaha
country: United States
facility: Warner Chilcott Research Site (Site #231)
state: Nebraska
city: Newington
country: United States
facility: Warner Chilcott Research Site (Site #253)
state: New Hampshire
city: Albuquerque
country: United States
facility: Warner Chilcott Research Site (Site #239)
state: New Mexico
city: New York
country: United States
facility: Warner Chilcott Research Site (Site #208)
state: New York
city: Rochester
country: United States
facility: Warner Chilcott Research Site (Site #240)
state: New York
city: Stony Brook
country: United States
facility: Warner Chilcott Research Site (Site #230)
state: New York
city: Raleigh
country: United States
facility: Warner Chilcott Research Site (Site #229)
state: North Carolina
city: Wilmington
country: United States
facility: Warner Chilcott Research Site (Site #250)
state: North Carolina
city: Beachwood
country: United States
facility: Warner Chilcott Research Site (Site #218)
state: Ohio
city: Philadelphia
country: United States
facility: Warner Chilcott Research Site (Site #256)
state: Pennsylvania
city: Warwick
country: United States
facility: Warner Chilcott Research Site (Site #214)
state: Rhode Island
city: Fountain Inn
country: United States
facility: Warner Chilcott Research Site (Site #219)
state: South Carolina
city: Goodlettsville
country: United States
facility: Warner Chilcott Research Site (Site #225)
state: Tennessee
city: Knoxville
country: United States
facility: Warner Chilcott Research Site (Site #216)
state: Tennessee
city: Arlington
country: United States
facility: Warner Chilcott Research Site (Site #252)
state: Texas
city: College Station
country: United States
facility: Warner Chilcott Research Site (Site #220)
state: Texas
city: Katy
country: United States
facility: Warner Chilcott Research Site (Site #201)
state: Texas
city: Pflugerville
country: United States
facility: Warner Chilcott Research Site (Site #223)
state: Texas
city: San Antonio
country: United States
facility: Warner Chilcott Research Site (Site #207)
state: Texas
city: Webster
country: United States
facility: Warner Chilcott Research Site (Site #224)
state: Texas
city: West Jordan
country: United States
facility: Warner Chilcott Research Site (Site #212)
state: Utah
city: Norfolk
country: United States
facility: Warner Chilcott Research Site (Site #244)
state: Virginia
city: Seattle
country: United States
facility: Warner Chilcott Research Site (Site #246)
state: Washington
city: Walla Walla
country: United States
facility: Warner Chilcott Research Site (Site #233)
state: Washington
city: Madison
country: United States
facility: Warner Chilcott Research Site (Site #232)
state: Wisconsin
Study officials:
affiliation: Allergan, plc
name: David Berk, MD
role: STUDY_DIRECTOR
References: