Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Healthy male or non pregnant female
≥ 12 and ≤ 40 years
Diagnosis of acne vulgaris (acne)
>18 years and provide written informed consent
Ages 12 to 17 and provide written assent and written informed consent from patient's legal representative
Must sign a HIPAA authorization
Minimum ≥ 25 non-inflammatory lesions
≥ 20 inflammatory lesions
≤ 2 nodulocystic lesions on the face
Acne of severity grade 2, 3, or 4 -Investigator's Global Assessment (IGA)
Refrain from all other topical acne medications or antibiotics during the 12-week treatment period except Investigational Product
All Female patients with a negative urine pregnancy test who use birth control from the study start to 30 days after the last administration of study drug
All male patients who use birth control with their partners, from the study start to 30 days after the last administration of study drug. Abstinence is acceptable. Female partners should use birth control
Must be willing and able to understand and comply with the protocol requirements and required study visits
In good health
Free from any clinically significant disease
Must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to use the same make-up, brand/type and maintain the same frequency of use throughout the study

Exclusion Criteria:

Female patients who are pregnant, nursing or planning to become pregnant during study
History or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis
Hypersensitivity or allergy to benzoyl peroxide, clindamycin and/or any of the study medication ingredients
Presence of any skin condition that would interfere with the diagnosis or assessment
Excessive facial hair
Wax epilation of the face within 14 days prior
Used oral retinoids or therapeutic vitamin A supplements of >10,000 units/day (multivitamins are allowed) within 6 months prior to or during the study
Estrogens or oral contraceptives for <3 months prior to baseline; Use of such therapy must remain constant throughout the study
Cryodestruction, chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, X-ray therapy procedures performed on the face within 1 month prior to or during the study
Any systemic (steroids, antibiotics treatment for acne, anti-inflammatory agents) treatments within 1 month prior to baseline or during the study
Any (topical steroids, topical retinoids, α-hydroxy/glycolic acid, benzoyl peroxide, topical anti-inflammatory agents, topical antibiotics) treatments within 2 weeks prior to baseline or during the study:
Intend to use Spironolactone
Intend to use tanning booths, sunbathing, or excessive exposure to the sun
Radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline
Unstable clinically significant medical disorders or life-threatening diseases
On-going malignancies requiring systemic treatment
Any malignancy of the facial area skin
Engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes
Consume excessive amounts of alcohol or use drugs of abuse
Participation in an investigational drug study within 30 days prior
Are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion
Previously enrolled in this study
Laser therapy, electrodessication and phototherapy to the facial area within 180 days prior to study entry
Cosmetic procedures which may affect the efficacy and safety profile of the study drug within 14 days prior to study entry
Currently have or have recently had bacterial folliculitis on the face