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



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:9 - 45
Updated:2/3/2019
Start Date:December 3, 2014
End Date:January 12, 2017

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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


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.
We found this trial at
55
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2296
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Jupiter, FL
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Albuquerque, New Mexico 87106
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Albuquerque, NM
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Arlington, TX
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2320
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Aventura, FL
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1934
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Bay City, MI
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2041
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Beachwood, OH
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Carlsbad, California 92008
73
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Carlsbad, CA
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Champaign, Illinois 61820
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Clarkston, Michigan 48346
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Clarkston, MI
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Clearwater, Florida 33761
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Clinton Township, Michigan 48038
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College Station, Texas 77845
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College Station, TX
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818
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Denver, CO
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Encinitas, California 92024
82
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Fort Gratiot, Michigan 48059
2000
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Fountain Inn, South Carolina 29644
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Fremont, California 94538
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Fremont, CA
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1512
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Fridley, MN
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Goodlettsville, Tennessee 37072
1766
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Goodlettsville, TN
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Hot Springs, Arkansas 71913
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Hot Springs, AR
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1331
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Katy, TX
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Knoxville, Tennessee 37917
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Lauderdale Lakes, Florida 33319
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Louisville, Kentucky 40217
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1649
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Madison, WI
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2311
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Miami, FL
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2306
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Miramar, FL
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1757
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Mobile, AL
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New York, NY
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Newington, New Hampshire 03801
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Norfolk, VA
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2127
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Ocala, FL
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Oceanside, California 92056
70
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1295
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Omaha, NE
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2186
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Orlando, FL
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Pflugerville, Texas 78660
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Philadelphia, Pennsylvania 19103
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Pinellas Park, Florida 33781
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Raleigh, North Carolina 27612
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Raleigh, NC
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Rochester, New York 14623
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Rochester, NY
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Rockville, Maryland 20850
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1182
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San Antonio, TX
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San Diego, California 92117
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Santa Ana, California 92701
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Santa Monica, California 90404
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Seattle, Washington 98105
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Snellville, Georgia 30078
1938
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Stony Brook, New York 11790
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2133
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Tampa, FL
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Walla Walla, Washington 99362
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Warwick, Rhode Island 02886
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Watertown, Massachusetts 02472
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1377
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Webster, TX
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561
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West Jordan, UT
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Wilmington, North Carolina 28405
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Wilmington, NC
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