A Treatment for Severe Inflammatory Acne Subjects
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel; Oral doxycycline hyclate
Intervention description: Topical acne therapy; Tetracycline-class oral antibacterial 200 mg daily (2 tablets [50 mg], twice daily)
Intervention MeSH terms: Doxycycline; Adapalene; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 186.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Demonstrate that a daily treatment regimen of adapalene 0.3%/benzoyl peroxide 2.5% gel + oral
      Doxycycline 200 mg is effective and safe in severe inflammatory acne with 3 or fewer nodules
      or cysts (non-nodulocystic) during a 12-week treatment period.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female subjects, 12 years of age or older at Screening visit.

          2. Subjects with a clinical diagnosis of severe inflammatory acne (IGA score of 4).

          3. Subjects with 4 or fewer nodules or cysts > 1 cm in diameter on the face.

          4. Subjects 18 years of age or older must read and sign the Informed Consent Form, which
             includes Photography Consent and HIPAA authorization, prior to any participation in
             the study. Consent will be obtained prior to any study-related procedures. Subjects
             under the age of 18 years must sign an Assent to Participate Form to participate in
             the study and must have one parent or guardian read and sign the Informed Consent Form
             prior to any study-related procedure. (The parent or guardian is not required to
             attend the following visits unless requested.)

        Key Exclusion Criteria:

          1. Subjects with nodulocystic or conglobate acne, acne fulminans, or secondary acne
             (chloracne, drug-induced acne, etc.).

          2. Subjects with 5 or more acne nodules or cysts > 1 cm in diameter on the face at
             Screening and Baseline visits.

          3. Female subjects who are pregnant, nursing, or planning a pregnancy during the study.

          4. Subjects who have used any systemic therapy directed at improving acne, including
             antibiotics, within 30 days prior to Baseline visit.

          5. Subjects who are at risk in terms of precautions, warnings, and contraindications for
             the investigational study drugs (see Appendix 14.1 for package inserts for adapalene
             0.3%/benzoyl peroxide 2.5% gel and doxycycline hyclate Tablets).

          6. Subjects with any other condition or circumstance which, in the Investigator's
             opinion, may put the subject at risk (e.g., a history of significant renal disease
             with impairment of renal function), confound the study results, or interfere with the
             subject's participation in the study.

          7. Sponsor and study site staff, relatives of staff members, or other individuals who
             would have access to the clinical study protocol.