Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - 45
Updated:2/3/2019
Start Date:June 30, 2012
End Date:January 31, 2013

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A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Different Doses of a Novel Tetracycline Compared to Placebo in the Treatment of Facial Acne Vulgaris, Study PR-10411

To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo
for the treatment of moderate to severe facial acne vulgaris.


Inclusion Criteria:

- if women of child-bearing potential, have a negative urine pregnancy test

- Willing to use only a non-medicated cleanser and to refrain from use of any other acne
medication, medicated cleanser, excessive sun exposure, and tanning booths for the
duration of the study

- Male or female, 12-45 years of age with body weight between 52 and 88 kg

- Diagnosis of acne vulgaris with:

20 to 50 inflammatory lesions (papules, pustules, and nodules) 30 to 100
noninflammatory lesions (open and closed comedones)

- No more than 2 nodules on the face

- Investigator's Global Assessment (IGA) score of moderate (3) to severe (4)

Exclusion Criteria:

- Dermatological condition of face or facial hair that could interfere with clinical
evaluations subjects who have used the following medications (topical refers only to
the facial area) will not be eligible:

Within 1 week prior to randomization:

- Medicated facial cleansers

- Topical acne treatments (other than those listed below)

Within 4 weeks prior to randomization:

- Topical retinoids

- Topical anti-inflammatories and corticosteroids

- Systemic antibiotics

- Systemic acne treatments

Within 12 weeks prior to randomization:

- Systemic retinoids

- Systemic corticosteroids

- Pseudomembranous colitis or antibiotic-associated colitis

- Hepatitis, liver damage or renal impairment
We found this trial at
37
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Clearwater, Florida 33761
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Albuquerque, New Mexico 87106
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Arlington, Texas 76011
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Arlington Heights, Illinois 60005
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Berlin, New Jersey 08009
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Boston, Massachusetts 02135
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Charlotte, North Carolina 28209
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Chicago, IL
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Cincinnati, Ohio 45249
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Coral Gables, Florida 33134
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Fridley, Minnesota 44532
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Gainesville, Florida 32605
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Granger, Indiana 46530
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Greer, South Carolina 29650
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Hot Springs, Arkansas 71913
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Indianapolis, Indiana 46256
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Los Angeles, California 90045
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Louisville, Kentucky 40202
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Lynchburg, Virginia 24501
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Miramar, Florida 33027
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Mobile, Alabama 36608
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Philadelphia, Pennsylvania 19103
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Pinellas Park, Florida 33781
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Portland, Oregon 97210
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Rochester, New York 14609
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Saint Louis, Missouri 63117
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Salisbury, North Carolina 28144
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San Antonio, Texas 78229
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San Diego, California 92103
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Santa Monica, California 90404
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Tucson, Arizona 85710
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Wilmington, North Carolina 28401
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