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NCT05030051 · ClinicalTrials.gov registry record · NA
A Proof of Concept Study to Evaluate the Efficacy and Tolerability of Skinpen on Male and Female Subjects' Dorsal Hands as a Treatment of Hand Aging
A NA study of Skin Aging, sponsored by Crown Laboratories.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT05030051: Completed NA study of Skin Aging, sponsored by Crown Laboratories.
NCT05030051 is a NA study of Skin Aging that has completed, run by Crown Laboratories. The registered enrollment target is 18 participants, below the 73-participant average among 9 other Skin Aging trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05030051, a NA study of Skin Aging, has completed, sponsored by Crown Laboratories.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This proof of concept study is being conducted over the course of 60 days followed by a 3-month post-treatment visit to assess the efficacy and tolerability of the Sponsor's SkinPen device when used to treat men and women with signs of aging on the dorsum of the hands. Overall assessment of clinical outcome and safety will be based on the evaluation of pre-and post-treatment photos comparing baseline to final visit. The subject's assessment of satisfaction will also be evaluated at Visit 3 and Visit 4. Finally, both the clinician's and subject's assessments will be characterized using a clinician assessment scale at the 3-month post-treatment visit.
Primary Outcome
This scale should be completed: • Based on a live assessment of the subject while referring to the subject's pre-treatment photographs of the dorsal hand and final visit Rating Description 1. Very Much Improved: Optimal cosmetic result in this subject. 2. Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject. 3. Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated. 4. No Change: Th
Conditions Studied
Interventions
- DEVICE SkinPen Precision System
Study Locations (1)
Texas
- Crown Laboratories - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-03-12 |
| Est. Completion | 2022-11-30 |
| Phase | NA |
What the finished NCT05030051 record still lists
NCT05030051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 73-participant average among 9 other Skin Aging trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Skin Aging appearing as the primary indexed condition, and to 1 intervention - of which SkinPen Precision System is the first listed.
NCT05030051 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05030051 about?
NCT05030051 is a clinical study titled "A Proof of Concept Study to Evaluate the Efficacy and Tolerability of Skinpen on Male and Female Subjects' Dorsal Hands as a Treatment of Hand Aging". This proof of concept study is being conducted over the course of 60 days followed by a 3-month post-treatment visit to assess the efficacy and tolerability of the Sponsor's SkinPen device when used to treat men and women with signs of aging on the dorsum of the hands. Overall assessment of clinical...
What is the current status of trial NCT05030051?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2021-03-12. Estimated completion is 2022-11-30.
What conditions does trial NCT05030051 study?
This clinical trial studies the following conditions: Skin Aging.
What interventions are being tested in trial NCT05030051?
The interventions under investigation include: SkinPen Precision System (DEVICE).
Who is sponsoring clinical trial NCT05030051?
This trial is sponsored by Crown Laboratories, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05030051 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05030051's enrollment target sits among peer trials
18 8th of 9 higher than 2 of 9 other Skin Aging trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Skin Aging 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.
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