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NCT05807412 · ClinicalTrials.gov registry record · Early Phase 1
Spread of PrabotulinumtoxinA-xvfs Versus OnabotulinumtoxinA in the Treatment of Forehead Rhytides
A Early Phase 1 study of Rhytides, sponsored by Lupo Center for Aesthetic and General Dermatology.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05807412: Completed Early Phase 1 study of Rhytides, sponsored by Lupo Center for Aesthetic and General Dermatology.
NCT05807412 is a Early Phase 1 study of Rhytides that has completed, run by Lupo Center for Aesthetic and General Dermatology. The registered enrollment target is 10 participants, below the 21-participant average among 5 other Rhytides trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05807412, a Early Phase 1 study of Rhytides, has completed, sponsored by Lupo Center for Aesthetic and General Dermatology.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Ten subjects will be enrolled in the study. Each subject will have their left and right forehead randomly assigned to receive 4 units of PrabotulinumtoxinA-xvfs or OnabotulinumtoxinA. Subjects will be reassessed at 2 weeks for evaluation of rhytide diminution around each injection point to assess relative diffusion of each drug in the forehead.
Primary Outcome
Primary endpoint is surface area of rhytid diminution. Surface area of rhytid reduction will be measured in centimeters squared (incorporating length and width measurements) two-weeks post-injection to assess differences, if any, in rhytid reduction on each side of the forehead by the blinded investigator.
Conditions Studied
Interventions
- DRUG OnabotulinumtoxinA
- DRUG PrabotulinumtoxinA-Xvfs
Study Locations (1)
Louisiana
- Lupo Center for Aesthetic and General Dermatology - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-05-01 |
| Est. Completion | 2024-02-26 |
| Phase | Early Phase 1 |
What the finished NCT05807412 record still lists
NCT05807412 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 21-participant average among 5 other Rhytides trials with a reported enrollment target (52% lower).
The record links to 1 condition, with Rhytides appearing as the primary indexed condition, and to 2 interventions - of which OnabotulinumtoxinA is the first listed.
NCT05807412 reports a single indexed study location in Louisiana.
Frequently Asked Questions
What is clinical trial NCT05807412 about?
NCT05807412 is a clinical study titled "Spread of PrabotulinumtoxinA-xvfs Versus OnabotulinumtoxinA in the Treatment of Forehead Rhytides". Ten subjects will be enrolled in the study. Each subject will have their left and right forehead randomly assigned to receive 4 units of PrabotulinumtoxinA-xvfs or OnabotulinumtoxinA. Subjects will be reassessed at 2 weeks for evaluation of rhytide diminution around each injection point to assess re...
What is the current status of trial NCT05807412?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2023-05-01. Estimated completion is 2024-02-26.
What conditions does trial NCT05807412 study?
This clinical trial studies the following conditions: Rhytides.
What interventions are being tested in trial NCT05807412?
The interventions under investigation include: OnabotulinumtoxinA (DRUG), PrabotulinumtoxinA-Xvfs (DRUG).
Who is sponsoring clinical trial NCT05807412?
This trial is sponsored by Lupo Center for Aesthetic and General Dermatology, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05807412 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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