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NCT04359823 · ClinicalTrials.gov registry record · Phase 1
DSAP Treatment Comparison: 2% Lovastatin/ 2% Cholesterol vs 2% Lovastatin Alone
A Phase 1 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT04359823: Completed Phase 1 study, sponsored by Medical University of South Carolina.
NCT04359823 is a Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04359823, a Phase 1 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This study will analyze the effects of topical lovastatin/cholesterol vs topical lovastatin alone in patients with disseminated superficial actinic porokeratosis. Patients will be divided into two groups, topical lovastatin/cholesterol and topical lovastatin alone. Patients will apply topical treatment twice daily to lesions over the course of 12 weeks. Follow up will occur in the virtual setting and photographs will be used to document progress.
Primary Outcome
The primary endpoint was the percentage of lesion clearance after 12 weeks of therapy using an exploratory clinical measure modified from a validated psoriasis index. The Disseminated Actinic Porokeratosis General Assessment Severity Index (DSAP-GASI) included plaque/rim elevation, scaling, and color (0= clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). Lesions of each patient were graded by 2 blinded physicians before and after treatment.
Interventions
- DRUG Lovastatin 2%, 2% Cholesterol Cream
- DRUG Lovastatin 2% Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2020-08-24 |
| Est. Completion | 2021-04-23 |
| Phase | Phase 1 |
What the finished NCT04359823 record still lists
NCT04359823 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Lovastatin 2%, 2% Cholesterol Cream is the first listed.
NCT04359823 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04359823 about?
NCT04359823 is a clinical study titled "DSAP Treatment Comparison: 2% Lovastatin/ 2% Cholesterol vs 2% Lovastatin Alone". This study will analyze the effects of topical lovastatin/cholesterol vs topical lovastatin alone in patients with disseminated superficial actinic porokeratosis. Patients will be divided into two groups, topical lovastatin/cholesterol and topical lovastatin alone. Patients will apply topical treatm...
What is the current status of trial NCT04359823?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2020-08-24. Estimated completion is 2021-04-23.
What interventions are being tested in trial NCT04359823?
The interventions under investigation include: Lovastatin 2%, 2% Cholesterol Cream (DRUG), Lovastatin 2% Cream (DRUG).
Who is sponsoring clinical trial NCT04359823?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04359823's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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