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COMPLETED
NCT04154293
PHASE2

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

Sponsor: LEO Pharma

View on ClinicalTrials.gov

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

Interventions

DRUG

Isotretinoin

Topical Isotretinoin ointment

OTHER

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