ABSORICA in Patients With Severe Recalcitrant Nodular Acne
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: Isotretinoin
Intervention description: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Intervention MeSH terms: Isotretinoin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 201.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      This is an uncontrolled, open-label study being conducted in approximately 200 healthy males,
      non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne.

      ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day will be administered for 4 weeks followed by
      1.0 mg/kg/day for 16 weeks. Female subjects consenting to use two forms of birth control or
      abstinence are included.
    

Eligibility criteria:

        General Inclusion Criteria Subjects must meet the following mandatory inclusion criteria at
        the time of screening to be eligible to enter the study and must agree to conform to the
        requirements of the study and the iPLEDGE program.

          -  Written informed consent, including mandatory photographic consent, on a
             gender-specific informed consent form (ICF) & Health Insurance Portability and
             Accountability Act (HIPAA) authorization prior to the performance of any study-related
             procedures.

          -  Pregnant females and females who are not to become pregnant during the ATP phase of
             the trial and for 30 days after receiving their last dose of study drug.

          -  Female subjects of childbearing potential ready to use 2 forms of effective
             contraception simultaneously for 1 month before starting Absorica® (isotretinoin),
             while taking Absorica® & for 1 month after Absorica® has been stopped.

          -  Male and female subjects of non-childbearing potential

        Specific Inclusion Criteria:

          -  Severe recalcitrant nodular acne.

          -  Five or more nodule lesions on the face.

          -  Treatment-naïve subjects.

          -  Age between 12 and 45 years.

          -  Weight between 40 and 110 kg.

          -  Female subjects of childbearing potential only: Negative results from serum pregnancy
             tests with a sensitivity of at least 25 milli-international unit/mL.

          -  Good general health as determined by the investigator based on the subject's medical
             history, physical examination, vital signs measurements, and laboratory test results.

          -  Subjects who present with stable & controlled diabetes mellitus (Types I and II).

          -  Subjects with previously diagnosed polycystic ovarian syndrome (PCOS) can be included
             in the study if in the opinion of the investigator they do not have any other
             clinically significant abnormality (eg, metabolic syndrome or elevated lipids

        Exclusion Criteria:

        General Exclusion Criteria

          -  Presence of any clinically significant physical examination finding, vital signs
             measurement, or abnormal laboratory value;

          -  Presence of a beard or other facial hair that could interfere with the study
             assessments;

          -  Participated in another clinical trial or received an investigational product within 3
             months prior to screening;

          -  History of excessive or suspected abuse of alcohol (based on the clinical judgment of
             the investigator), recreational drugs, and/or drugs of abuse, e.g., club drugs,
             cocaine, ecstasy/ methylenedioxymethamphetamine, heroin, inhalants, marijuana,
             methamphetamine, phencyclidine, prescription medications, anabolic steroids, etc.

          -  Use of prohibited or restricted prior or concomitant medications. Female Specific
             Exclusion Criteria

          -  Are pregnant;

          -  Are at a high risk for becoming pregnant or likely to become pregnant during
             treatment;

          -  Are breast-feeding or considering breast-feeding during the course of the study;

          -  Have a known history of PCOS with another clinically significant abnormality (eg,
             metabolic syndrome or elevated lipids);

          -  Are unable or unwilling to maintain compliance with birth control measures