A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis

Trial ID or NCT#

NCT04154293

Status

not recruiting iconNOT 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

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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Investigator(s)

Joyce Teng, MD, PhD
Joyce Teng, MD, PhD
Dermatologist, Pediatric dermatologist
Professor of Dermatology and, by courtesy, of Pediatrics

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Contact

Elidia Tafoya
650-724-1982

View on ClinicalTrials.gov