P3 Study in Acne Comparing Once Daily SB204 and Vehicle



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:9 - 99
Updated:11/21/2018
Start Date:February 22, 2016
End Date:December 21, 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 SB204 and Vehicle Gel Once Daily 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
Orlando, Florida 32801
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Orlando, FL
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Albuquerque, New Mexico 87102
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Albuquerque, NM
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Anaheim, California 92801
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Anaheim, CA
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Arlington, Texas 76011
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Arlington, TX
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Beaumont, Texas 77701
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Beaumont, TX
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Berlin, New Jersey 08009
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Berlin, NJ
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Boca Raton, Florida 33486
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Boca Raton, FL
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Carrollton, Texas 75010
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Carrollton, TX
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Charleston, South Carolina 29414
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Charleston, SC
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Chattanooga, Tennessee 37421
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Chattanooga, TN
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Chicago, Illinois 60611
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Chicago, IL
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Cincinnati, Ohio 45255
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Cincinnati, OH
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Detroit, Michigan 48183
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Detroit, MI
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Encinitas, California 92024
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Encinitas, CA
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Fresno, California 93720
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Fresno, CA
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Fresno, California 93720
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Fresno, CA
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Glenn Dale, Maryland 20769
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Glenn Dale, MD
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Hialeah, Florida 33012
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Hialeah, FL
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High Point, North Carolina 27262
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High Point, NC
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Homestead, Florida 33030
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Homestead, FL
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Houston, Texas 77055
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Houston, TX
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Las Vegas, Nevada 89129
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Las Vegas, NV
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Lauderdale Lakes, Florida 33406
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Lauderdale Lakes, FL
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Louisville, Kentucky 40202
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Louisville, KY
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Miami, Florida 33144
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Miami, FL
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Montclair, New Jersey 07042
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Montclair, NJ
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New Orleans, Louisiana 70112
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New Orleans, LA
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New York, New York 10155
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New York, NY
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Norfolk, Virginia 23502
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Norfolk, VA
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North Miami Beach, Florida 33162
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North Miami Beach, FL
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Oceanside, California 92056
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Oceanside, CA
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Omaha, Nebraska 68134
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Omaha, NE
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Orlando, Florida 32814
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Orlando, FL
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Ormond Beach, Florida 32174
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Ormond Beach, FL
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Plano, Texas 75093
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Plano, TX
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Plano, Texas 75234
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Plano, TX
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Portland, Oregon 97210
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Portland, OR
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Quincy, Massachusetts 02169
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Quincy, MA
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Rochester, New York 14623
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Rochester, NY
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Saint Joseph, Missouri 64506
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Saint Joseph, MO
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12747 Olive Boulevard
Saint Louis, Missouri 63141
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Saint Louis, MO
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Salt Lake City, Utah 84117
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Salt Lake City, UT
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San Antonio, Texas 78218
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San Antonio, TX
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San Antonio, Texas 78229
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San Antonio, TX
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San Diego, California 92103
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San Diego, CA
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San Diego, California 92123
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San Diego, CA
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Santa Rosa, California 95405
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Santa Rosa, CA
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South Miami, Florida 33413
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South Miami, FL
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Stony Brook, New York 11790
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Stony Brook, NY
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Sugar Land, Texas 77479
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Sugar Land, TX
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Tampa, Florida 33609
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Tampa, FL
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Troy, Michigan 48084
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Troy, MI
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Wellington, Florida 33414
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Wellington, FL
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Wichita, Kansas 67207
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Wichita, KS
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Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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