Topical Sirolimus for the Treatment of Pachyonychia Congenita (PC)

Inclusion Criteria: Subjects must: * Be capable of understanding the purpose and risks of the study and sign a written Informed Consent Form (ICF) * Be male or female ≥ 16 years of age at the time of the screening visit * Have a confirmed diagnosis of PC by genotyping (e.g., familial) and clinically correlated painful keratoderma. * Have roughly symmetrical calluses of similar severity on the plantar surface of both feet * Women of childbearing potential must have a negative serum pregnancy test * Subjects, whether male or female, with reproductive potential and who are sexually active must agree to use double-barrier contraception methods Exclusion Criteria: A Subject with any of the following criteria is not eligible for inclusion in this study: * Use of other investigational drugs within 30 days of the screening visit and/or has not recovered from any side effects of prior investigational drugs or procedure in the affected area (e.g., a biopsy) * Significant condition in the dermatologic treatment area such as trauma, or nonhealing chronic wound * Pregnant or nursing (lactating) female, or a positive serum pregnancy test * Active infection either systemic or local near the site of treatment requiring chronic or prolonged use of antimicrobial agents * Known immunodeficiency including: Hepatitis A; Hepatitis B; Hepatitis C; Human Immunodeficiency Virus (HIV) Prior and Current Treatment * Unable to be discontinued from drugs known to either be inducers or inhibitors of…