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

NCT02322866 | Completed Phase 3 Results

• 1 other identifier: SC1402
• Study Type: interventional
• Target: 1,034
• Locations: 1 country
• Sites: 57

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

Conditions

Acne Vulgaris

Keywords

acne

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12

  Baseline (Day 1) to Week 12

• Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9

  Baseline (Day 1) to Week 9

• Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6

  Baseline (Day 1) to Week 6

• Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3

  Baseline (Day 1) to Week 3

• Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9

  Baseline (Day 1) to Week 9

Study Arms (2)

Sarecycline

EXPERIMENTAL

Sarecycline tablets, 1.5 milligram(mg)/kilogram(kg)/day, taken orally once daily for 12 weeks.

Drug: Sarecycline

Placebo

PLACEBO COMPARATOR

Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.

Drug: Placebo

Interventions

Sarecycline DRUG

1.5 mg/kg/day taken orally at the same time each day.

Sarecycline

Placebo DRUG

Placebo-matching sarecycline tablets, taken orally at the same time each day.

Placebo

Eligibility Criteria

• Age: 9 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• inflammatory lesions (papules, pustules and nodules)
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Almirall, S.A.: lead
• Allergan: collaborator

Study Sites (57)

Warner Chilcott Research Site (Site #206)

Mobile, Alabama, 36608, United States

Location

Warner Chilcott Research Site (Site #236)

Hot Springs, Arkansas, 71913, United States

Location

Warner Chilcott Research Site (Site #245)

Carlsbad, California, 92008, United States

Location

Warner Chilcott Research Site (Site #234)

Encinitas, California, 92024, United States

Location

Warner Chilcott Research Site (Site #209)

Fremont, California, 94538, United States

Location

Warner Chilcott Research Site (Site #215)

Oceanside, California, 92056, United States

Location

Warner Chilcott Research Site (Site #204)

San Diego, California, 92123, United States

Location

Warner Chilcott Research Site (Site #254)

San Diego, California, 92123, United States

Location

Warner Chilcott Research Site (Site #257)

Santa Ana, California, 92701, United States

Location

Warner Chilcott Research Site (Site #243)

Santa Monica, California, 90404, United States

Location

Warner Chilcott Research Site (Site #222)

Denver, Colorado, 80220, United States

Location

Warner Chilcott Research Site (Site #237)

Aventura, Florida, 33180, United States

Location

Warner Chilcott Research Site (Site #226)

Clearwater, Florida, 33761, United States

Location

Warner Chilcott Research Site (Site #238)

Jupiter, Florida, 33458, United States

Location

Warner Chilcott Research Site (Site #255)

Lauderdale Lakes, Florida, 33319, United States

Location

Warner Chilcott Research Site (Site #249)

Miami, Florida, 33142, United States

Location

Warner Chilcott Research Site (Site #202)

Miami, Florida, 33144, United States

Location

Warner Chilcott Research Site (Site #211)

Miramar, Florida, 33027, United States

Location

Warner Chilcott Research Site (Site #247)

Ocala, Florida, 34471, United States

Location

Warner Chilcott Research Site (Site #241)

Orlando, Florida, 32806, United States

Location

Warner Chilcott Research Site (Site #228)

Pinellas Park, Florida, 33781, United States

Location

Warner Chilcott Research Site (Site #203)

Tampa, Florida, 33609, United States

Location

Warner Chilcott Research Site (Site #242)

Snellville, Georgia, 30078, United States

Location

Warner Chilcott Research Site (Site #210)

Champaign, Illinois, 61820, United States

Location

Warner Chilcott Research Site (Site #213)

Louisville, Kentucky, 40202, United States

Location

Warner Chilcott Research Site (Site #217)

Rockville, Maryland, 20850, United States

Location

Warner Chilcott Research Site (Site #248)

Watertown, Massachusetts, 02472, United States

Location

Warner Chilcott Research Site (Site #205)

Bay City, Michigan, 48706, United States

Location

Warner Chilcott Research Site (Site #251)

Clarkston, Michigan, 48346, United States

Location

Warner Chilcott Research Site (Site #235)

Clinton Township, Michigan, 48038, United States

Location

Warner Chilcott Research Site (Site #227)

Fort Gratiot, Michigan, 48059, United States

Location

Warner Chilcott Research Site (Site #221)

Fridley, Minnesota, 55432, United States

Location

Warner Chilcott Research Site (Site #231)

Omaha, Nebraska, 68144, United States

Location

Warner Chilcott Research Site (Site #253)

Newington, New Hampshire, 03801, United States

Location

Warner Chilcott Research Site (Site #239)

Albuquerque, New Mexico, 87106, United States

Location

Warner Chilcott Research Site (Site #208)

New York, New York, 10155, United States

Location

Warner Chilcott Research Site (Site #240)

Rochester, New York, 14623, United States

Location

Warner Chilcott Research Site (Site #230)

Stony Brook, New York, 11790, United States

Location

Warner Chilcott Research Site (Site #229)

Raleigh, North Carolina, 27612, United States

Location

Warner Chilcott Research Site (Site #250)

Wilmington, North Carolina, 28405, United States

Location

Warner Chilcott Research Site (Site #218)

Beachwood, Ohio, 44122, United States

Location

Warner Chilcott Research Site (Site #256)

Philadelphia, Pennsylvania, 19103, United States

Location

Warner Chilcott Research Site (Site #214)

Warwick, Rhode Island, 02886, United States

Location

Warner Chilcott Research Site (Site #219)

Fountain Inn, South Carolina, 29644, United States

Location

Warner Chilcott Research Site (Site #225)

Goodlettsville, Tennessee, 37072, United States

Location

Warner Chilcott Research Site (Site #216)

Knoxville, Tennessee, 37922, United States

Location

Warner Chilcott Research Site (Site #252)

Arlington, Texas, 76011, United States

Location

Warner Chilcott Research Site (Site #220)

College Station, Texas, 77845, United States

Location

Warner Chilcott Research Site (Site #201)

Katy, Texas, 77494, United States

Location

Warner Chilcott Research Site (Site #223)

Pflugerville, Texas, 78660, United States

Location

Warner Chilcott Research Site (Site #207)

San Antonio, Texas, 78218, United States

Location

Warner Chilcott Research Site (Site #224)

Webster, Texas, 77598, United States

Location

Warner Chilcott Research Site (Site #212)

West Jordan, Utah, 84088, United States

Location

Warner Chilcott Research Site (Site #244)

Norfolk, Virginia, 23507, United States

Location

Warner Chilcott Research Site (Site #246)

Seattle, Washington, 98105, United States

Location

Warner Chilcott Research Site (Site #233)

Walla Walla, Washington, 99362, United States

Location

Warner Chilcott Research Site (Site #232)

Madison, Wisconsin, 53719, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

sarecycline

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• David Berk, MD

  Allergan, plc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 23, 2014
• Study Start: December 3, 2014
• Primary Completion: January 12, 2017
• Study Completion: January 12, 2017
• Last Updated: February 1, 2019
• Results First Posted: May 7, 2018

Record last verified: 2019-01

Locations

US (57)