The Use of Oracea and Epiduo Forte in Severe Acne Patients
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: Doxycycline Anhydrous 40 MG; Adapalene/Benzoyl Peroxide Gel 0.3-2.5%
Intervention description: One Oracea Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals; Epiduo Forte should be applied in a thin layer to affected areas of the face and/or trunk once daily after washing, with care taken to avoid the eyes, lips, and mucous membranes
Intervention MeSH terms: Doxycycline; Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a single-center, open label pilot study. The study is comprised of 5 study visits;
      Screening, Baseline, and weeks 4, 8, and 12. All subjects will receive Oracea once daily (QD)
      and Epiduo Forte at Baseline. We will evaluate Investigator Global Assessment (IGA), total
      lesion count, inflammatory lesion count, non-inflammatory lesion count, adverse events and
      concomitant medications.
    

Eligibility criteria:

        Inclusion Criteria:

        i. Outpatient, male or female subjects of any race, and at least 12 years of age or older.
        Female subjects of childbearing potential must have a negative urine pregnancy test result
        at Baseline (test must have a sensitivity of at least 25 milli-international
        units/milliliter [mIU/ml] for human chorionic gonadotropin) and practice a reliable method
        of contraception throughout the study:

        A female is considered of childbearing potential unless she is:

          -  postmenopausal for at least 12 months prior to study drug administration;

          -  without a uterus and/or both ovaries; or

          -  has been surgically sterile for at least 6 months prior to study drug administration

        Reliable methods of contraception are:

          -  hormonal methods or intrauterine device in use ≥90 days prior to study drug
             administration;

          -  barrier methods plus spermicide in use at least 14 days prior to study drug
             administration; or

          -  vasectomized partner (vasectomy must be performed 3 months prior to first study drug
             administration or in the alternative a zero sperm count will suffice) [Exception:
             female subjects of childbearing potential who are not sexually active will not be
             required to practice a reliable method of contraception. These subjects may be
             enrolled at the Investigator's discretion if they are counseled to remain sexually
             inactive during the study and understand the possible risks in getting pregnant during
             the study.] ii. Facial acne IGA score of 4 iii. Minimum of 20 or more inflammatory
             lesions and 20 or more non-inflammatory lesions and not more than 4 nodules iv. Able
             to understand the requirements of the study and sign Informed Consent/HIPAA
             Authorization forms. Subjects under the legal age of consent in the state where the
             study is conducted must also have the written, informed consent of a parent or legal
             guardian

        Exclusion Criteria:

        i. Female subjects who are pregnant (positive urine pregnancy test ), breast-feeding, or
        who are of childbearing potential and not practicing a reliable method of birth control ii.
        Allergy or sensitivity to any component of the test medication iii. Subjects who have not
        complied with the proper wash-out periods for prohibited medications (Supplement I)> iv.
        Medical condition that, in the opinion of the investigator, contraindicates the subject's
        participation in the clinical study v. Skin disease/disorder that might interfere with the
        diagnosis or evaluation of acne vulgaris vi. Evidence of recent alcohol or drug abuse vii.
        History of poor cooperation, non-compliance with medical treatment, or unreliability viii.
        Exposure to an investigational drug study within 30 days of the Baseline Visit -