Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne

Exclusion Criteria

• •Female patients will be excluded from the study if they:
• •* Are pregnant;
• •* Are at high risk for becoming pregnant or likely to become pregnant during treatment;
• •* Will be breast-feeding or considering breast feeding during the course of the study.
• •Known history or presence of any clinically significant unstable medical condition(s) which in the opinion of the investigator could pose a risk for the safety of the patient including any previous history of gastrointestinal disease.
• •Patients with any skin disease or other condition that might interfere with the evaluation of recalcitrant nodular acne.
• •Patients will be interviewed using the SCID-CT current and lifetime modules for Major Depression, Mania, and Psychosis. Patients with a lifetime history of psychosis will be excluded. Patients with a history of major depressive, manic, hypomanic or mixed episodes will not be excluded unless they have had an episode during the preceding year.
• •Patients with any past or current psychotic symptoms.
• •Patients reporting any suicidal behaviour (including attempts, interrupted attempts, aborted attempts, or other preparatory behaviours), within the past year, or serious suicidal ideation in the past year, will be excluded from study participation.
• •A lifetime history of wishing to be dead, non-specific active suicidal thoughts or active suicidal ideation without intent to act will not result in exclusion.
• •Known history or suspected carcinoma.
• •Known history of liver or kidney disorders (hepatic and renal insufficiency).
• •Known history or current pseudotumor cerebri (benign intracranial hypertension).
• •Patients with HLA-B27 related disease, rheumatoid arthritis, rickets or other vitamin D depletion disease or phosphate metabolic disease, severe scoliosis \> 15 Cobb angle, history of back surgery/injuries, ongoing use of anticonvulsants known to affect bone metabolism and other genetic or acquired rheumatologic and joint diseases.
• •All pediatric patients with serum 25-hydroxyvitamin D levels \< 20 ng/mL.
• •Patients with hearing disorders who in the opinion of the investigator would not be able to participate in audiometric testing for the study.
• •Hypersensitivity or idiosyncratic reaction to isotretinoin, Vitamin A and/or any other drug substances with similar activity.
• •Allergy to soy beans, soy bean oil or any other ingredients in the study medications.
• •On a special diet within four weeks prior to drug administration (e.g., liquid, protein, raw food diet).
• •Difficulty consuming two (2) meals a day to sustain weight and health.