A Phase 3, Double-Blind 2 Arm Study in the Treatment of Acne Vulgaris



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:9 - 99
Updated:3/17/2019
Start Date:June 29, 2017
End Date:September 5, 2018

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A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-123 Lotion and IDP-123 Vehicle Lotion in the Treatment of Acne Vulgaris

This is a multicenter, randomized, double-blind, vehicle-controlled study designed to assess
the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle
Lotion.

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed
to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123Vehicle Lotion.
To be eligible for the study subjects must be at least 9 years of age and have a clinical
diagnosis of moderate to severe acne.

Inclusion Criteria:

1. Male or female at least 9 years of age and older;

2. Written and verbal informed consent must be obtained. Subjects less than age of
consent must sign an assent for the study and a parent or a legal guardian must sign
the informed consent (if subject reaches age of consent during the study they should
be re-consented at the next study visit);

3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global
Severity assessment at the baseline visit;

4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count
no less than 20 but no more than 50;

5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no
less than 25 but no more than 100;

Exclusion Criteria:

1. Use of an investigational drug or device within 30 days of enrollment or participation
in a research study concurrent with this study;

2. Any dermatological conditions on the face that could interfere with clinical
evaluations such as acne conglobata, acne fulminans, secondary acne, perioral
dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis,
eczema;

3. Any underlying disease(s) or some other dermatological condition of the face that
requires the use of interfering topical or systemic therapy or makes evaluations and
lesion count inconclusive;

4. Subjects with a facial beard or mustache that could interfere with the study
assessments;

5. Subjects with more than two (2) facial nodules;

6. Evidence or history of cosmetic-related acne;
We found this trial at
41
sites
Webster, Texas 77598
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Arlington Heights, Illinois 60005
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Austin, Texas 78759
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Austin, TX
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Boca Raton, Florida 33486
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Boise, Idaho 83704
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Cincinnati, Ohio 45236
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Detroit, Michigan 48201
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Dublin, Ohio 43016
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Dublin, OH
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Gresham, Oregon 97030
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High Point, North Carolina 27262
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Hot Springs, Arkansas 71913
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Johnston, Rhode Island 02919
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Katy, Texas 77449
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Knoxville, Tennessee 37909
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La Mesa, California 91941
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Louisville, Kentucky 40217
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Manhattan Beach, California 90266
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Metairie, Louisiana 70006
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Murrieta, California 92562
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Nashville, Tennessee 37115
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New Albany, Indiana 47150
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New York, New York 10075
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Newnan, Georgia 30263
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Norfolk, Virginia 23507
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North Miami Beach, Florida 33162
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2099 North Beach Street
Ormond Beach, Florida 32174
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Overland Park, Kansas 66215
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Pembroke Pines, Florida 33028
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Peterborough, Ontario
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Phoenix, Arizona 85032
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2500 Dallas Parkway
Plano, Texas 75093
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Sacramento, California 94203
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Salt Lake City, Utah 84117
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San Antonio, Texas 78201
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San Diego, California 92123
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Sanford, Florida 32771
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220 West Colfax Avenue
South Bend, Indiana 46601
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South Bend, IN
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Spokane, Washington 99201
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Warren, Michigan 48088
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West Palm Beach, Florida 33401
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Wheat Ridge, Colorado 80033
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