Recruitment

Recruitment Status
Completed
Estimated Enrollment
320

Inclusion Criteria

Subjects with ≥20 inflammatory facial lesions (papules, pustules) inclusive of the nose, with a maximum of 9 inflammatory pustules.
Male or non-pregnant female subjects with facial acne vulgaris, 12 years of age or older.
An Investigator's Global Assessment (IGA) of Moderate (3) or Severe (4)
Subjects with ≥20 inflammatory facial lesions (papules, pustules) inclusive of the nose, with a maximum of 9 inflammatory pustules.
Male or non-pregnant female subjects with facial acne vulgaris, 12 years of age or older.
An Investigator's Global Assessment (IGA) of Moderate (3) or Severe (4)

Exclusion Criteria

Subjects with more than 2 facial nodulocystic lesions
Subjects with greater that 75 facial non-inflammatory lesions (open and/or closed comedones; excluding the nose)
Subjects with acne conglobate, acne fulminans, and secondary acne (chloracne, drug-induced acne, polycystic ovarian syndrome, etc.)
Subjects with more than 2 facial nodulocystic lesions
Subjects with greater that 75 facial non-inflammatory lesions (open and/or closed comedones; excluding the nose)
Subjects with acne conglobate, acne fulminans, and secondary acne (chloracne, drug-induced acne, polycystic ovarian syndrome, etc.)

Summary

Conditions
Acne Vulgaris
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 12 years and 125 years
Gender
Both males and females

Inclusion Criteria

Subjects with ≥20 inflammatory facial lesions (papules, pustules) inclusive of the nose, with a maximum of 9 inflammatory pustules.
Male or non-pregnant female subjects with facial acne vulgaris, 12 years of age or older.
An Investigator's Global Assessment (IGA) of Moderate (3) or Severe (4)
Subjects with ≥20 inflammatory facial lesions (papules, pustules) inclusive of the nose, with a maximum of 9 inflammatory pustules.
Male or non-pregnant female subjects with facial acne vulgaris, 12 years of age or older.
An Investigator's Global Assessment (IGA) of Moderate (3) or Severe (4)

Exclusion Criteria

Subjects with more than 2 facial nodulocystic lesions
Subjects with greater that 75 facial non-inflammatory lesions (open and/or closed comedones; excluding the nose)
Subjects with acne conglobate, acne fulminans, and secondary acne (chloracne, drug-induced acne, polycystic ovarian syndrome, etc.)
Subjects with more than 2 facial nodulocystic lesions
Subjects with greater that 75 facial non-inflammatory lesions (open and/or closed comedones; excluding the nose)
Subjects with acne conglobate, acne fulminans, and secondary acne (chloracne, drug-induced acne, polycystic ovarian syndrome, etc.)

Locations

Fort Gratiot, Michigan, 48059
Albuquerque, New Mexico, 87106
Spokane, Washington, 99204
Encino, California, 91436
Tampa, Florida, 33609
...
Fort Gratiot, Michigan, 48059
Albuquerque, New Mexico, 87106
Spokane, Washington, 99204
Encino, California, 91436
Tampa, Florida, 33609
New York, New York, 10017
Newnan, Georgia, 30263
Austin, Texas, 78705
West Palm Beach, Florida, 33401
San Diego, California, 92117
Boca Raton, Florida, 33486
High Point, North Carolina, 27262
College Station, Texas, 77845
Fridley, Minnesota, 55432
Santa Monica, California, 90404
Stony Brook, New York, 11790
Nashville, Tennessee, 37215
San Antonio, Texas, 78229
Pinellas Park, Florida, 33781
Raleigh, North Carolina, 27612

Tracking Information

NCT #
NCT02066545
Collaborators
Not Provided
Investigators
Not Provided