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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT01628549

Run by

Almirall, S.A.

People needed

285

Starts

2012-06-30

Expected to finish

2013-01-31

Last updated by the study team

2019-02-01

Who can join

Age: 12 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Warner Chilcott Investigational Site — Mobile, Alabama, United States
• Warner Chilcott Investigational Site — Tucson, Arizona, United States
• Warner Chilcott Investigational Site — Hot Springs, Arkansas, United States
• Warner Chilcott Investigational Site — Los Angeles, California, United States
• Warner Chilcott Investigational Site — San Diego, California, United States
• Warner Chilcott Investigational Site — Santa Monica, California, United States
• Warner Chilcott Investigational Site — Clearwater, Florida, United States
• Warner Chilcott Investigational Site — Coral Gables, Florida, United States
• Warner Chilcott Investigational Site — Gainesville, Florida, United States
• Warner Chilcott Investigational Site — Miami, Florida, United States
• Warner Chilcott Investigational Site — Miramar, Florida, United States
• Warner Chilcott Investigational Site — Pinellas Park, Florida, United States
• Warner Chilcott Investigational Site — Arlington Heights, Illinois, United States
• Warner Chilcott Investigational Site — Chicago, Illinois, United States
• Warner Chilcott Investigational Site — Granger, Indiana, United States
• Warner Chilcott Investigational Site — Indianapolis, Indiana, United States
• Warner Chilcott Investigational Site — Louisville, Kentucky, United States
• Warner Chilcott Investigational Site — Boston, Massachusetts, United States
• Warner Chilcott Investigational Site — Fridley, Minnesota, United States
• Warner Chilcott Investigational Site — St Louis, Missouri, United States
• Warner Chilcott Investigational Site — Berlin, New Jersey, United States
• Warner Chilcott Investigational Site — Albuquerque, New Mexico, United States
• Warner Chilcott Investigational Site — Rochester, New York, United States
• Warner Chilcott Investigational Site — Rochester, New York, United States
• Warner Chilcott Investigational Site — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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