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NCT04154293 · ClinicalTrials.gov registry record · Phase 2
A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis
A Phase 2 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT04154293: Completed Phase 2 study, sponsored by LEO Pharma.
NCT04154293 is a Phase 2 study that has completed, run by LEO Pharma. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04154293, a Phase 2 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study 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
Primary Outcome
Number of subjects with Visual Index for Ichthyosis Severity (VIIS) treatment success, defined as 50% or greater decreased in VIIS scaling score
Interventions
- DRUG Isotretinoin
- OTHER Vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-12-03 |
| Est. Completion | 2021-08-30 |
| Phase | Phase 2 |
What the finished NCT04154293 record still lists
NCT04154293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Isotretinoin is the first listed.
NCT04154293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04154293 about?
NCT04154293 is a clinical study titled "A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis". 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...
What is the current status of trial NCT04154293?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2019-12-03. Estimated completion is 2021-08-30.
What interventions are being tested in trial NCT04154293?
The interventions under investigation include: Isotretinoin (DRUG), Vehicle (OTHER).
Who is sponsoring clinical trial NCT04154293?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04154293's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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