P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:9 - 99
Updated:10/20/2018
Start Date:February 19, 2016
End Date:December 9, 2016

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A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of Once Daily SB204 and Vehicle Gel in the Treatment of Acne Vulgaris

This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel
group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.

This is a double-blind, placebo controlled study in subjects with moderate to severe acne.
Subjects who satisfy the entry criteria will be randomized to SB204 4% QD or Vehicle Gel QD
in a 1:1 ratio. Efficacy assessments will include Investigator Global Assessments (IGA) and
inflammatory and non-inflammatory lesion counts. Subjects will return for post-Baseline
evaluation at Weeks 2, 4, 8, and 12/Early Termination (ET).

Inclusion Criteria:

- Moderate to severe acne

- Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones)
on the face

- Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)

Exclusion Criteria:

- Women of child-bearing potential who are pregnant, nursing, considering becoming
pregnant

- Any dermatologic condition that could interfere with clinical evaluations including
severe, recalcitrant cystic acne
We found this trial at
55
sites
Ormond Beach, Florida 32174
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Ormond Beach, FL
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Austin, Texas 78735
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Austin, TX
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Austin, Texas 78759
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Austin, TX
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Bay City, Michigan 48706
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Bay City, MI
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Birmingham, Alabama 35233
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Birmingham, AL
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Boston, Massachusetts 02114
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Boston, MA
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Bradenton, Florida 34201
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Bradenton, FL
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Broomall, Pennsylvania 19008
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Broomall, PA
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Bryan, Texas 77802
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Bryan, TX
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Cerritos, California 90703
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Cerritos, CA
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Channelview, Texas 77530
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Channelview, TX
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Charlotte, North Carolina 28277
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Charlotte, NC
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216 Chula Vista Street
Chula Vista, California 91911
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Chula Vista, CA
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Cincinnati, Ohio 45246
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Cincinnati, OH
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Dallas, Texas 75230
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Dallas, TX
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Encino, California 91436
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Encino, CA
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Gresham, Oregon 97030
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Gresham, OR
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Hershey, Pennsylvania 17033
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Hershey, PA
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Hialeah, Florida 33012
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Hialeah, FL
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7070 Allensby Street
Houston, Texas 77030
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Houston, TX
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Huntington Beach, California 92647
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Huntington Beach, CA
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La Mesa, California 91942
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La Mesa, CA
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Louisville, Kentucky 40217
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Louisville, KY
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Lynchburg, Virginia 24501
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Lynchburg, VA
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Miami, Florida 33157
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Miami, FL
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Miami Lakes, Florida 33016
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Miami Lakes, FL
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Miami Springs, Florida 33166
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Miami Springs, FL
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Mobile, Alabama 36608
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Mobile, AL
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Monroe, Louisiana 71203
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Monroe, LA
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Morristown, New Jersey 07962
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Morristown, NJ
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New Albany, Indiana 47150
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New Albany, IN
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100-24 197th Street
New York, New York 10024
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New York, NY
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Newnan, Georgia 30263
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Newnan, GA
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Norfolk, Nebraska 68701
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Norfolk, NE
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Norfolk, Virginia 23507
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Norfolk, VA
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Omaha, Nebraska 68144
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Omaha, NE
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Overland Park, Kansas 66215
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Overland Park, KS
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Philadelphia, Pennsylvania 19103
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Philadelphia, PA
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Phoenix, Arizona 85018
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Phoenix, AZ
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Pinellas Park, Florida 33781
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Pinellas Park, FL
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Plano, Texas 75024
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Plano, TX
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Raleigh, North Carolina 27612
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Raleigh, NC
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Richmond, Kentucky 40475
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Richmond, KY
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Sacramento, California 95821
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Sacramento, CA
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675 Old Ballas Road
Saint Louis, Missouri 63141
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Saint Louis, MO
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3902 North Marguerite Street
Saint Petersburg, Florida 33716
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Saint Petersburg, FL
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Salisbury, North Carolina 28144
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Salisbury, NC
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San Antonio, Texas 78229
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San Antonio, TX
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San Diego, California 92123
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San Diego, CA
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Sanford, Florida 32771
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Sanford, FL
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Santa Ana, California 92705
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Santa Ana, CA
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Santa Monica, California 90404
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Santa Monica, CA
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Savannah, Georgia 31406
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Savannah, GA
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Tampa, Florida 33607
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Tampa, FL
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Tampa, Florida 33634
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Tampa, FL
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