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
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Albuquerque, New Mexico
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Arlington, Texas 76011
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Beachwood, Ohio 44122
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Goodlettsville, Tennessee
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Hershey, Pennsylvania
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Hot Springs, Arkansas
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New York, New York 10022
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Spokane, Washington
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Stony Brook, New York
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