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A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis
Sponsor: LEO Pharma
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
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
Key Details
Gender
All
Age Range
9 Years - Any
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2019-12-03
Completion Date
2021-08-30
Last Updated
2026-05-22
Healthy Volunteers
No
Conditions
Interventions
Isotretinoin
Topical Isotretinoin ointment
Vehicle
Topical Vehicle Ointment
Locations (11)
Medical Dermatology Specialists
Phoenix, Arizona, United States
Stanford University School of Medicine
Palo Alto, California, United States
Yale Center for Clinical Investigation
New Haven, Connecticut, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Austin Institute for Clinical Research, Inc
Metairie, Louisiana, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Queensland Children's Hospital
Brisbane, Queensland, Australia
Premier Specialists, The church
Kogarah, Sydney, Australia
Murdoch Children's Research Institute, RCH
Melbourne, Victoria, Australia