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Microneedling Device
SkinPen Precision System for Skin Aging
N/A
Waitlist Available
Research Sponsored by Crown Laboratories, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-month post treatment
Awards & highlights
Study Summary
This trial is testing a new device to treat aging hands. Results will be based on before and after photos, patient satisfaction, and a clinician assessment scale.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-month post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-month post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinician's global aesthetic improvement assessment (CGAIS)
Secondary outcome measures
Subject's global aesthetic improvement assessment (SGAIS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: SkinPen Precision SystemExperimental Treatment1 Intervention
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 assessment will be characterized using a clinician assessment scale at the 3 month post-treatment visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SkinPen Precision System
2021
N/A
~20
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Who is running the clinical trial?
Crown Laboratories, Inc.Lead Sponsor
3 Previous Clinical Trials
124 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
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