Clinical trial NCT02320149: Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne
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
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: 2014-12-19
Enrollment: 968
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 1.5mg/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
* 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

Primary outcomes:
measure: Absolute Change in Facial Inflammatory Lesion Counts at Week 12
timeFrame: Baseline (Day 1) to Week 12
measure: Percentage of Participants With Investigator Global Assement (IGA) Success at Week 12
timeFrame: Baseline (Day 1) to 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 Weeks 6
measure: Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3
timeFrame: Baseline (Day 1) to Week 3
measure: Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12
timeFrame: Baseline (Day 1) to Week 12
measure: Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9
timeFrame: Baseline (Day 1) to Week 9
measure: Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6
timeFrame: Baseline (Day 1) to Week 6
measure: Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3
timeFrame: Baseline (Day 1) to Week 3
measure: Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12
timeFrame: Baseline (Day 1) to Week 12
measure: Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9
timeFrame: Baseline (Day 1) to Week 9
measure: Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6
timeFrame: Baseline (Day 1) to Week 6
measure: Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3
timeFrame: Baseline (Day 1) to Week 3
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Warner Chilcott Research Site (Site #155)
state: California
city: Encino
country: United States
facility: Warner Chilcott Research Site (Site #129)
state: California
city: La Mesa
country: United States
facility: Warner Chilcott Research Site (Site #150)
state: California
city: Los Angeles
country: United States
facility: Warner Chilcott Research Site (Site #136)
state: California
city: Sacramento
country: United States
facility: Warner Chilcott Research Site (Site #147)
state: California
city: San Diego
country: United States
facility: Warner Chilcott Research Site (Site #123)
state: California
city: San Diego
country: United States
facility: Warner Chilcott Research Site (Site #125)
state: California
city: Santa Rosa
country: United States
facility: Warner Chilcott Research Site (Site #139)
state: California
city: Tustin
country: United States
facility: Warner Chilcott Research Site (Site #157)
state: California
city: Denver
country: United States
facility: Warner Chilcott Research Site (Site #122)
state: Colorado
city: Wheat Ridge
country: United States
facility: Warner Chilcott Research Site (Site #148)
state: Colorado
city: New Haven
country: United States
facility: Warner Chilcott Research Site (Site #133)
state: Connecticut
city: Boca Raton
country: United States
facility: Warner Chilcott Research Site (Site #130)
state: Florida
city: Boynton Beach
country: United States
facility: Warner Chilcott Research Site (Site #152)
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Research Site (Site #102)
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Research Site (Site #145)
state: Florida
city: North Miami Beach
country: United States
facility: Warner Chilcott Research Site (Site #140)
state: Florida
city: Orange Park
country: United States
facility: Warner Chilcott Research Site (Site #151)
state: Florida
city: Sanford
country: United States
facility: Warner Chilcott Research Site (Site #108)
state: Florida
city: West Palm Beach
country: United States
facility: Warner Chilcott Research Site (Site #110)
state: Florida
city: Atlanta
country: United States
facility: Warner Chilcott Research Site (Site #154)
state: Georgia
city: Augusta
country: United States
facility: Warner Chilcott Research Site (Site #120)
state: Georgia
city: Boise
country: United States
facility: Warner Chilcott Research Site (Site #124)
state: Idaho
city: Chicago
country: United States
facility: Warner Chilcott Research Site (Site #106)
state: Illinois
city: Plainfield
country: United States
facility: Warner Chilcott Research Site (Site #112)
state: Indiana
city: South Bend
country: United States
facility: Warner Chilcott Research Site (Site #113)
state: Indiana
city: Louisville
country: United States
facility: Warner Chilcott Research Site (Site #117)
state: Kentucky
city: Lake Charles
country: United States
facility: Warner Chilcott Research Site (Site #135)
state: Louisiana
city: Metairie
country: United States
facility: Warner Chilcott Research Site (Site #153)
state: Louisiana
city: Detroit
country: United States
facility: Warner Chilcott Research Site (Site #137)
state: Michigan
city: Warren
country: United States
facility: Warner Chilcott Research Site (Site #111)
state: Michigan
city: Saint Louis
country: United States
facility: Warner Chilcott Research Site (Site #119)
state: Missouri
city: Omaha
country: United States
facility: Warner Chilcott Research Site (Site #138)
state: Nebraska
city: Henderson
country: United States
facility: Warner Chilcott Research Site (Site #103)
state: Nevada
city: Verona
country: United States
facility: Warner Chilcott Research Site (Site #127)
state: New Jersey
city: New York
country: United States
facility: Warner Chilcott Research Site (Site #146)
state: New York
city: New York
country: United States
facility: Warner Chilcott Research Site (Site #132)
state: New York
city: Smithtown
country: United States
facility: Warner Chilcott Research Site (Site #134)
state: New York
city: High Point
country: United States
facility: Warner Chilcott Research Site (Site #107)
state: North Carolina
city: Cincinnati
country: United States
facility: Warner Chilcott Research Site (Site #126)
state: Ohio
city: Warren
country: United States
facility: Warner Chilcott Research Site (Site #143)
state: Ohio
city: Gresham
country: United States
facility: Warner Chilcott Research Site (Site #149)
state: Oregon
city: Portland
country: United States
facility: Warner Chilcott Research Site (Site #131)
state: Oregon
city: Greer
country: United States
facility: Warner Chilcott Research Site (Site #114)
state: South Carolina
city: Knoxville
country: United States
facility: Warner Chilcott Research Site (Site #128)
state: Tennessee
city: Nashville
country: United States
facility: Warner Chilcott Research Site (Site #109)
state: Tennessee
city: Austin
country: United States
facility: Warner Chilcott Research Site (Site #116)
state: Texas
city: Dallas
country: United States
facility: Warner Chilcott Research Site (Site #104)
state: Texas
city: El Paso
country: United States
facility: Warner Chilcott Research Site (Site #115)
state: Texas
city: Houston
country: United States
facility: Warner Chilcott Research Site (Site #142)
state: Texas
city: Houston
country: United States
facility: Warner Chilcott Research Site (Site #105)
state: Texas
city: Plano
country: United States
facility: Warner Chilcott Research Site (Site #101)
state: Texas
city: San Antonio
country: United States
facility: Warner Chilcott Research Site (Site #118)
state: Texas
city: Layton
country: United States
facility: Warner Chilcott Research Site (Site #156)
state: Utah
city: Salt Lake City
country: United States
facility: Warner Chilcott Research Site (Site #141)
state: Utah
city: Charlottesville
country: United States
facility: Warner Chilcott Research Site (Site #121)
state: Virginia
city: Spokane
country: United States
facility: Warner Chilcott Research Site (Site #144)
state: Washington
Study officials:
affiliation: Warner Chilcott, an Affiliate of Allergan plc
name: Alexandre Kaoukhov, MD
role: STUDY_DIRECTOR
References: