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NCT03738800 · ClinicalTrials.gov registry record · Phase 2
A Safety, Efficacy and Systemic Exposure Study of CD5789 Cream in Adults and Adolescents With Lamellar Ichthyosis
A Phase 2 study, sponsored by Mayne Pharma International Pty.
- Terminated
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
NCT03738800: Clinical Trial Phase 2 study, sponsored by Mayne Pharma International Pty.
NCT03738800 is a Phase 2 study that was terminated before completion, run by Mayne Pharma International Pty. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03738800, a Phase 2 study, was terminated before completion, sponsored by Mayne Pharma International Pty.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
Study Summary
This is a phase 2 randomized, multi-center, double-blind, vehicle controlled, 90 day, safety, efficacy, and systemic exposure study followed by a 90 day open-label extension of trifarotene cream in adults and adolescents with autosomal recessive ichthyosis with lamellar scale.
Primary Outcome
The percentage of subjects in each treatment group who experienced successful resolution of LI where "success" is defined as clear/almost clear on treated areas and at least a 2-grade change from Baseline at Day 90/end-of-treatment (EOT) in the Double-blind Period on the 5-point IGA full body scale.
Interventions
- DRUG CD5789 Cream 200 µg/g
- DRUG CD5789 Cream 100 µg/g
- DRUG CD5789 Cream Vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2019-05-01 |
| Est. Completion | 2021-09-03 |
| Phase | Phase 2 |
Why NCT03738800 stopped before completion
NCT03738800 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 3 interventions - of which CD5789 Cream 200 µg/g is the first listed.
NCT03738800 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03738800 about?
NCT03738800 is a clinical study titled "A Safety, Efficacy and Systemic Exposure Study of CD5789 Cream in Adults and Adolescents With Lamellar Ichthyosis". This is a phase 2 randomized, multi-center, double-blind, vehicle controlled, 90 day, safety, efficacy, and systemic exposure study followed by a 90 day open-label extension of trifarotene cream in adults and adolescents with autosomal recessive ichthyosis with lamellar scale.
What is the current status of trial NCT03738800?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2019-05-01. Estimated completion is 2021-09-03.
What interventions are being tested in trial NCT03738800?
The interventions under investigation include: CD5789 Cream 200 µg/g (DRUG), CD5789 Cream 100 µg/g (DRUG), CD5789 Cream Vehicle (DRUG).
Who is sponsoring clinical trial NCT03738800?
This trial is sponsored by Mayne Pharma International Pty, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03738800's enrollment target sits among peer trials
65 987th of 2000 higher than 1,005 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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