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
Spokane, Washington
1779
mi
from 43215
Spokane, WA
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Albuquerque, New Mexico
1330
mi
from 43215
Albuquerque, NM
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Arlington, Texas 76011
927
mi
from 43215
Arlington, TX
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?
mi
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Barrie,
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Beachwood, Ohio 44122
130
mi
from 43215
Beachwood, OH
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Birmingham, Alabama
491
mi
from 43215
Birmingham, AL
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Chicago, Illinois
274
mi
from 43215
Chicago, IL
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Detroit, Michigan
163
mi
from 43215
Detroit, MI
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Goodlettsville, Tennessee
321
mi
from 43215
Goodlettsville, TN
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Greenville, South Carolina
354
mi
from 43215
Greenville, SC
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Hershey, Pennsylvania
337
mi
from 43215
Hershey, PA
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Hot Springs, Arkansas
667
mi
from 43215
Hot Springs, AR
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Knoxville, Tennessee
280
mi
from 43215
Knoxville, TN
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Los Angeles, California
1972
mi
from 43215
Los Angeles, CA
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992
mi
from 43215
Miami, FL
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978
mi
from 43215
Miramar, FL
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699
mi
from 43215
Mobile, AL
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New York, New York 10022
442
mi
from 43215
New York, NY
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465
mi
from 43215
Newnan, GA
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Raleigh, North Carolina
375
mi
from 43215
Raleigh, NC
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Sacramento, California
2043
mi
from 43215
Sacramento, CA
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Salt Lake City, Utah
1513
mi
from 43215
Salt Lake City, UT
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San Antonio, Texas
1138
mi
from 43215
San Antonio, TX
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Santa Monica, California
1986
mi
from 43215
Santa Monica, CA
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Snellville, Georgia
425
mi
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Snellville, GA
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Stony Brook, New York
261
mi
from 43215
Stony Brook, NY
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