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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 is a Phase 2 study that has completed, run by LEO Pharma. The registered enrollment target is 34 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04154293
The ClinicalTrials.gov registry entry for NCT04154293 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LEO Pharma, which has 65 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Isotretinoin is the first listed.
NCT04154293 reports 0 study locations.
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.
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