A Proof of Concept Study to Evaluate the Efficacy and Tolerability of Microneedling With SkinPen in Female and Male Subjects With Facial Acne Vulgaris, Ages 18 Through 45
NCT05071274 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2022-03-28
Summary
This single-center, proof of concept trial is being conducted over the course of 42 days followed by a 2-month post-last treatment visit in order to assess the efficacy and tolerability of the Sponsor's SkinPen device in treating Acne Vulgaris on the face.
Conditions
- Acne Vulgaris
Interventions
- DEVICE
-
Skinpen Prescision System
Skinpen Precision is an automated nonsurgical micro needling device designed for use by licensed health care practitioners or individuals directed by practitioners. The device incorporates a sterile Microneedle cartridge and Biosheath for single use only.
Sponsors & Collaborators
-
Crown Laboratories, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-15
- Primary Completion
- 2022-03-18
- Completion
- 2022-03-18
- FDA Device
- Yes
Countries
- United States
Study Locations
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