A Safety, Efficacy and Systemic Exposure Study of CD5789 Cream in Adults and Adolescents With Lamellar Ichthyosis

Exclusion criteria

• ✕. Subject has any variant of ichthyosis other than LI or another disorder of keratinization, including syndromic ichthyoses.
• ✕. Subject has current moderate or severe stinging/burning at Screening.
• ✕. Subject has an ongoing cutaneous infection or any other significant concomitant skin disease (other than the LI) which, in the investigator's opinion, may interfere with the study assessments.
• ✕. Subject with fasting triglycerides \>200 mg/dL or \>2.25 mmol/L and/or total cholesterol \>250 mg/dL or \>6.5 mmol/L. Subjects whose triglycerides and/or total cholesterol are within normal limits with a stable dose of lipid-lowering agents for at least 6 months may be included.
• ✕. Subject was previously treated with trifarotene/CD5789 in an acne or ichthyosis study.
• ✕. Subject has any other significant concomitant disease, or poorly controlled medical condition other than LI that in the investigator's opinion may put him or her at risk if he or she takes part in the study, and/or that may interfere with the study assessments.
• ✕. Subject has a medical condition that potentially alters bone metabolism (e.g., osteoporosis, thyroid dysfunction, Cushing syndrome, Crohn's disease, or ulcerative colitis). Subjects with hypothyroidism who are on a stable dose of thyroid hormone replacement therapy and whose thyroid-stimulating hormone (TSH) is normal may be included
• ✕. Subject is being treated for major depression disorder and/or has a history of major depression or suicide attempt requiring hospitalization, medications, and close psychiatric surveillance to prevent suicide attempts.