A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - Any
Updated:1/1/2014
Start Date:June 2012
End Date:March 2014

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A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Dose Escalating Study to Evaluate the Safety and Efficacy of Cortexolone 17a-Propionate (CB-03-01) Cream Applied Once or Twice-Daily for 12 Weeks in Subjects With Facial Acne Vulgaris

CB-03-01 is being developed for the topical treatment of acne vulgaris, an
androgen-dependent skin disorder. The purpose of this study is to compare the safety and
efficacy of multiple concentrations of CB-03-01 to vehicle in the treatment of acne
vulgaris.


Inclusion Criteria:

- Subject is male or non-pregnant female. Females must be post-menopausal, surgically
sterile or using highly effective birth control methods.

- Subject has provided written and verbal informed consent/assent.

- Subject has facial acne vulgaris (including the nose).

- Subject is willing to comply with study instructions and return to the clinic for
required visits.

- Subject has used the same type and brand of make-up, other facial products (including
cleanser) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at
least one month prior to the study start and agrees to continue his/her other general
skin and hair care products and regimen for the entire study.

Exclusion Criteria:

- Subject is pregnant, lactating, or is planning to become pregnant during the study.

- Subject is currently enrolled in an investigational drug or device study.

- Subject has received an investigational drug or been treated with an investigational
device within 30 days prior to the study start.

- Subject has the need or plans to be exposed to artificial tanning devices or
excessive sunlight during the trial

- Subject has used any of the following topical anti-acne preparations or procedures on
the face:

- Topical anti-acne treatments including but not limited to over-the-counter acne
cleaners or treatments, benzoyl peroxide, antibiotics, azelaic acid, sulfa based
products, corticosteroids and salicylic acid within two weeks of the initiation
of treatment.

- Retinoids, including tazarotene, adapalene, tretinoin, within four weeks of the
initiation of treatment.

- Light treatments, microdermabrasion or chemical peels within eight weeks of the
initiation of treatment.

- Subject has used the following systemic anti-acne medications:

- Corticosteroids (including intramuscular and intralesional injections) within
four weeks of the initiation of treatment. Inhaled, intranasal or ocular
corticosteroids are allowed if use is stable (stable use is defined as dose and
frequency unchanged for at least four weeks prior to the initiation of
treatment).

- Antibiotics within four weeks of the initiation of treatment with the exception
of five days or less of antibiotic therapy during this period, but with no
antibiotics use permitted within one week prior to the initiation of treatment.

- Spironolactone within eight weeks of the initiation of treatment with the
exception of five days or less of spironolactone therapy during this period, but
with no spironolactone use permitted within one week prior to the initiation of
treatment.

- Retinoid therapy within six months of the initiation of treatment.
We found this trial at
13
sites
Norfolk, Virginia 23507
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Norfolk, VA
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Arlington Heights, Illinois 60005
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Arlington Heights, IL
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College Station, Texas 77845
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College Station, TX
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Hershey, PA
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Houston, Texas 77030
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Houston, TX
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Johnston, Rhode Island 02919
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Johnston, RI
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Los Angeles, California 90045
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Los Angeles, CA
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Plainfield, Indiana 46168
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Plainfield, IN
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San Diego, California 92123
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San Diego, CA
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San Diego, California 92123
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San Diego, CA
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Sanford, FL
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Smithtown, New York 11787
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Smithtown, NY
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Snellville, Georgia 30078
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Snellville, GA
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