Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris

A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Different Doses of a Novel Tetracycline Compared to Placebo in the Treatment of Facial Acne Vulgaris, Study PR-10411

To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo for the treatment of moderate to severe facial acne vulgaris.

Inclusion Criteria:

• if women of child-bearing potential, have a negative urine pregnancy test

• Willing to use only a non-medicated cleanser and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study

• Male or female, 12-45 years of age with body weight between 52 and 88 kg

• Diagnosis of acne vulgaris with:

  20 to 50 inflammatory lesions (papules, pustules, and nodules) 30 to 100 noninflammatory lesions (open and closed comedones)

• No more than 2 nodules on the face

• Investigator's Global Assessment (IGA) score of moderate (3) to severe (4)

Exclusion Criteria:

• Dermatological condition of face or facial hair that could interfere with clinical evaluations subjects who have used the following medications (topical refers only to the facial area) will not be eligible:

Within 1 week prior to randomization:

• Medicated facial cleansers
• Topical acne treatments (other than those listed below)

Within 4 weeks prior to randomization:

• Topical retinoids
• Topical anti-inflammatories and corticosteroids
• Systemic antibiotics
• Systemic acne treatments

Within 12 weeks prior to randomization:

• Systemic retinoids
• Systemic corticosteroids
• Pseudomembranous colitis or antibiotic-associated colitis
• Hepatitis, liver damage or renal impairment