Phase III
The ASCEND Study
- Study HIC#:2000032809
- Last Updated:07/23/2024
This is a study for those 6 years or older to evaluate the efficacy and safety of topical TMB-001 0.05% ointment for 12-24 weeks for the treatment of congenital Ichthyosis.
- Age6 years and older
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Nicole Olszewski
- Phone Number: 1-203-785-5505
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Trial Purpose and Description
This is a study for those 6 years or older to evaluate the efficacy and safety of topical TMB-001 0.05% ointment for 12-24 weeks for the treatment of congenital Ichthyosis.
Eligibility Criteria
- 6 years or older,
- not pregnant,
- if childbearing age 2 forms of birth control,
- clinical diagnosis of CI based upon phenotype and has a genetic confirmation of either ARCI (including but not exclusively transglutaminase 1-deficient, ALOX-12B) or RXLI (e.g., deletion of steroid sulfatase gene) subtypes of congenital Ichthyosis,
- documented history of moderate to severe disease at Screening,
- subject and parent/guardian (if applicable) are willing and able to apply the study treatment(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
Principal Investigator
- Score: 1
