A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
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
Official Title
A Randomized, Parallel, Double-Blind, Vehicle Controlled Study to Evaluate the Safety and Efficacy of Two Concentrations of Topical TMB-001 for the Treatment of Congenital Ichthyosis
Eligibility Criteria
- * Subject is male or female, 9 years of age or older at Visit 2 (Baseline)* Subject has provided written informed consent* Females of child bearing potential must be surgically sterile or agree to 2 forms of birth control* Subject has clinical diagnosis of Congenital Ichthyosis with genetic confirmation of subtype* Subject has between 10% and 90% total BSA affected by Congenital Ichthyosis* Subject has at least 2 VIIS assessment areas with a scaling score of 3 or greater
- * Subject has inflammatory skin diseases unrelated to ichthyosis* Subject has used other prohibited topical treatments in the assessment areas within certain days from baseline* Subject has used systemic retinoids within12 weeks of baseline* Subject has untreated secondary infections* Subject has lesions suspicious for skin cancer or untreated skin cancers
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Elidia Tafoya
650-724-1982
View on ClinicalTrials.gov
