BCT-HA Kit for Dehydrated and Wrinkled Skin
NCT05514834 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2024-04-29
Summary
This study will assess the efficacy of Cellular MatrixTM BCT-HA Kit treatment compared to placebo condition on revitalization and skin rejuvenation on the midface. Particular attention will be made to the safety aspects, as well as the histological consequences of treatment.
Conditions
- Rhytides
- Wrinkle
Interventions
- DEVICE
-
Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3)
Injections with platelet-rich plasma and hyaluronic acid
- OTHER
-
PRP Only
platelet rich plasma without hyaluronic acid
- OTHER
-
Placebo
Neither PRP nor hyaluronic acid
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Maria Hordinsky, MD · University of Minnesota
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-06-10
- Primary Completion
- 2023-10-01
- Completion
- 2024-02-29
- FDA Device
- Yes
Countries
- United States
Study Locations
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