Lamellar Ichthyosis

 

Below is a list of our lamellar ichthyosis studies that are currently enrolling.

A Phase III, Multicenter, Double Blinded Vehicle Controlled Study of TMB-001 - with a Parallel Optional Maximal Use Arm - in the Treatment of RXLI (X-linked) or ARCI Ichthyosis in Subjects Aged ≥6 Years 

• Population: Patients aged 6 years or older 

• Study Condition: RXLI or ARCI Icthyosis

• Study Design: This study aims to evaluate the safety and efficacy of isotretinoin ointment (TMB-001 0.05%) in treating subjects 6 years of age or older with lamellar icthyosis. Subjects with ARCI/RXCI will be randomized 2:1, to either receive the TMB-001 .05% isotretinoin ointment or a vehicle ointment - applied daily - for 3 weeks. Subsequently, dosing will be increased to twice daily for 9 weeks. If significant improvement is observed at the end of the 9 weeks, subjects will be randomized 1:1 to receive the TMB-001 0.05% ointment, either applied daily or twice-daily, for 12 weeks. 

• A separate arm of the study which is designed to assess the bodily absorption of the ointment is also planned. Subjects are treated with TMB-001 0.05% for 12 weeks twice a day combined with blood draws in the first two weeks of treatment. 

• Compensation will be provided, as well as covering all travel costs.

 

 

Please contact Dr. Caroline Porter for more information regarding ongoing lamellar ichthyosis studies. 

 

Email: portecar@musc.edu

Phone: (843) 876-0110