Safety and Efficacy Study of CLS001Topical Gel Compared to Vehicle in Subjects With Inflammatory Acne Vulgaris
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 320
Inclusion Criteria
- 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)
- 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.
Exclusion Criteria
- 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
- Subjects with greater that 75 facial non-inflammatory lesions (open and/or closed comedones; excluding the nose)
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
- 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)
- 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.
Exclusion Criteria
- 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
- Subjects with greater that 75 facial non-inflammatory lesions (open and/or closed comedones; excluding the nose)
Tracking Information
- NCT #
- NCT02066545
- Collaborators
- Not Provided
- Investigators
- Not Provided
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