A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis
Status:
Completed
Trial end date:
2021-08-30
Target enrollment:
Participant gender:
Summary
The purpose of this study is to investigate the efficacy and safety of two concentrations of
topically applied ointment formulation of isotretinoin called TMB-001 (0.05% and 0.1%
isotretinoin) in subjects 9 years of age and older for the treatment of congenital ichthyosis
(CI), including recessive X-linked ichthyosis (RXLI) and autosomal recessive congenital
ichthyosis-lamellar ichthyosis (ARCI-LI) subtypes.
Funding Source FDA-OOPD