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

Completed · Phase 2

Conditions studied: Congenital Ichthyosis

In brief

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

Key facts

Study ID: NCT04154293
Run by: LEO Pharma
People needed: 34
Starts: 2019-12-03
Expected to finish: 2021-08-30
Last updated by the study team: 2026-05-22

Who can join

Age: 9 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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