Recruitment

Recruitment Status
Completed
Estimated Enrollment
320

Inclusion Criterias

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 Criterias

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.)
Subjects with more than 2 facial nodulocystic lesions

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 Criterias

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 Criterias

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.)
Subjects with more than 2 facial nodulocystic lesions

Locations

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

Tracking Information

NCT #
NCT02066545
Collaborators
Not Provided
Investigators
Not Provided