BCT-HA Kit for Dehydrated and Wrinkled Skin

NCT05514834 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-04-29

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05514834 on ClinicalTrials.gov