CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Isotretinoin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04154293
NCT04154293Phase 2Completed
CompareCT.gov

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

LEO Pharma·interventional·Posted Nov 6, 2019·Updated May 22, 2026

In Brief

A Phase 2 clinical trial evaluating Isotretinoin and Vehicle for Congenital Ichthyosis. Completed, enrolled 34 participants across 11 sites in 2 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Ichthyosis
CountriesAustralia, United States
CollaboratorsTimber Pharmaceuticals Inc.

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedNov 6, 2019
Enrollment StartDec 3, 2019
Primary CompletionAug 20, 2021
Study CompletionAug 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.7 years ago

Interventions

Isotretinoindrug

Topical Isotretinoin ointment

Vehicleother

Topical Vehicle Ointment