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.
This study is designed to collect efficacy, safety, and quality of life (QOL) data from
subjects who receive Absorica® without food. The study will investigate the treatment
efficacy, frequency of relapse once the treatment has been discontinued, quality of life
during the active treatment and during a 2-year post treatment period and the overall safety
of treatment with Absorica®.
This is a single-arm, open-label study consisting of 2 phases: a 20-week (5-month) open-label
Active Treatment Period (ATP) and a 104-week (2-year) post treatment period (PTP). The total
study duration is to be 124 weeks, excluding a screening period. During the ATP, after week 2
visit, visits will be scheduled at 4-week intervals for a total of 8 visits (1 screening
visit, 1 baseline visit, and 6 on-study visits). During the PTP, the first visit will be 4
weeks after End of Treatment (EOT), the second visit will be 12 weeks after EOT, and
subsequent visits will be scheduled at 26-week (± 2 weeks) intervals for a total of 6 visits.
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
- 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
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
- 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
- Are pregnant;
- Are at a high risk for becoming pregnant or likely to become pregnant during
- 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