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

Use our guide to learn which trials are right for you!

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
sites
Carlsbad, California 92008
?
mi
from
Carlsbad, CA
Click here to add this to my saved trials
Albuquerque, New Mexico 87106
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Aventura, FL
Click here to add this to my saved trials
?
mi
from
Bay City, MI
Click here to add this to my saved trials
?
mi
from
Beachwood, OH
Click here to add this to my saved trials
Champaign, Illinois 61820
?
mi
from
Champaign, IL
Click here to add this to my saved trials
Clarkston, Michigan 48346
?
mi
from
Clarkston, MI
Click here to add this to my saved trials
Clearwater, Florida 33761
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Clinton Township, Michigan 48038
?
mi
from
Clinton Township, MI
Click here to add this to my saved trials
College Station, Texas 77845
?
mi
from
College Station, TX
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
Encinitas, California 92024
?
mi
from
Encinitas, CA
Click here to add this to my saved trials
Fort Gratiot, Michigan 48059
?
mi
from
Fort Gratiot, MI
Click here to add this to my saved trials
Fountain Inn, South Carolina 29644
?
mi
from
Fountain Inn, SC
Click here to add this to my saved trials
Fremont, California 94538
?
mi
from
Fremont, CA
Click here to add this to my saved trials
?
mi
from
Fridley, MN
Click here to add this to my saved trials
Goodlettsville, Tennessee 37072
?
mi
from
Goodlettsville, TN
Click here to add this to my saved trials
Hot Springs, Arkansas 71913
?
mi
from
Hot Springs, AR
Click here to add this to my saved trials
?
mi
from
Jupiter, FL
Click here to add this to my saved trials
?
mi
from
Katy, TX
Click here to add this to my saved trials
Knoxville, Tennessee 37917
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Lauderdale Lakes, Florida 33319
?
mi
from
Lauderdale Lakes, FL
Click here to add this to my saved trials
Louisville, Kentucky 40217
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miramar, FL
Click here to add this to my saved trials
?
mi
from
Mobile, AL
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Newington, New Hampshire 03801
?
mi
from
Newington, NH
Click here to add this to my saved trials
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
?
mi
from
Ocala, FL
Click here to add this to my saved trials
Oceanside, California 92056
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Pflugerville, Texas 78660
?
mi
from
Pflugerville, TX
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19103
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pinellas Park, Florida 33781
?
mi
from
Pinellas Park, FL
Click here to add this to my saved trials
Raleigh, North Carolina 27612
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Rochester, New York 14623
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Rockville, Maryland 20850
?
mi
from
Rockville, MD
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92117
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Santa Ana, California 92701
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Seattle, Washington 98105
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Snellville, Georgia 30078
?
mi
from
Snellville, GA
Click here to add this to my saved trials
Stony Brook, New York 11790
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Walla Walla, Washington 99362
?
mi
from
Walla Walla, WA
Click here to add this to my saved trials
Warwick, Rhode Island 02886
?
mi
from
Warwick, RI
Click here to add this to my saved trials
Watertown, Massachusetts 02472
?
mi
from
Watertown, MA
Click here to add this to my saved trials
?
mi
from
Webster, TX
Click here to add this to my saved trials
?
mi
from
West Jordan, UT
Click here to add this to my saved trials
Wilmington, North Carolina 28405
?
mi
from
Wilmington, NC
Click here to add this to my saved trials