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

Exclusion Criteria

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

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

Exclusion Criteria

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

Tracking Information

NCT #
NCT02066545
Collaborators
Not Provided
Investigators
Not Provided