Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - Any
Updated:6/30/2018
Start Date:July 2013
End Date:March 2014

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A Multi-center, Randomized, Double-blind, Parallel-group Vehicle and Active Controlled Study to Compare the Efficacy and Safety of CD0271 0.3% / CD1579 2.5% Topical Gel Versus Topical Gel Vehicle in Subjects With Acne Vulgaris

The study hypothesis are based on the assumption that :

- CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical
Gel Vehicle in the overall population and in the subgroup of severe Subjects

- CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable
safety and tolerability profile


Inclusion Criteria:

1. Male or female, who is 12 years of age or older at Screening visit.

2. Clinical diagnosis of acne vulgaris with facial involvement.

3. An IGA of Moderate (3) or Severe (4) at Baseline visit.

4. A minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on
the face (including the nose) at Baseline visit.

5. A minimum of 30 but not more than 150 non-inflammatory lesions (open comedones and
closed comedones) on the face (including the nose) at Baseline visit.

Exclusion Criteria:

1. More than 2 acne nodules on the face at Baseline visit.

2. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
nodulo cystic acne, or acne requiring systemic treatment.

3. Underlying diseases or other dermatologic conditions that require the use of
interfering topical or systemic therapy or that might interfere with study assessments
such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. This
includes clinically significant abnormal findings, uncontrolled or serious disease, or
any medical or surgical condition, that may either interfere with the interpretation
of the clinical trial results, and/or put the subject at significant risk (according
to Investigator's judgment) if he/she participates in the clinical trial.

4. The subject has received, applied or taken some specified treatments within the
specified timeframe prior to the Baseline visit

5. The subject is unwilling to refrain from use of prohibited medication during the
clinical trial.

6. Use of hormonal contraceptives solely for control of acne.
We found this trial at
26
sites
Santa Monica, California
27
mi
from 91732
Santa Monica, CA
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Albuquerque, New Mexico
652
mi
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Albuquerque, NM
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Arlington, Texas 76011
1207
mi
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Arlington, TX
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?
mi
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Barrie,
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Beachwood, Ohio 44122
2041
mi
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Beachwood, OH
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Birmingham, Alabama
1785
mi
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Birmingham, AL
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Chicago, Illinois
1729
mi
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Chicago, IL
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Detroit, Michigan
1966
mi
from 91732
Detroit, MI
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Goodlettsville, Tennessee
1766
mi
from 91732
Goodlettsville, TN
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Greenville, South Carolina
2019
mi
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Greenville, SC
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Hershey, Pennsylvania
2295
mi
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Hershey, PA
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Hot Springs, Arkansas
1421
mi
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Hot Springs, AR
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Knoxville, Tennessee
1923
mi
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Knoxville, TN
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Los Angeles, California
13
mi
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Los Angeles, CA
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2319
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Miami, FL
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2309
mi
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Miramar, FL
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1757
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Mobile, AL
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New York, New York 10022
2351
mi
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New York, NY
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1900
mi
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Newnan, GA
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Raleigh, North Carolina
2218
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Raleigh, NC
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Sacramento, California
366
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Sacramento, CA
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Salt Lake City, Utah
570
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Salt Lake City, UT
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San Antonio, Texas
1188
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San Antonio, TX
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Snellville, Georgia
1938
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Snellville, GA
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Spokane, Washington
939
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Spokane, WA
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Stony Brook, New York
2182
mi
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Stony Brook, NY
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