Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3) for Wrinkles

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Minnesota, Minneapolis, MN
Wrinkles+1 More
Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3) - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Wrinkles

Treatment Effectiveness

Study Objectives

6 Primary · 0 Secondary · Reporting Duration: 4 weeks after treatment 1st, 2nd and 3rd treatments and 32 weeks after enrollment

Week 32
Physician's Global assessment to measure quality of life
Immediately after 1st, 2nd and 3rd treatments
Visual Analog Score for patients
Week 32
Change in FACE-Q Score
Change in Global Aesthetic Improvement Scale
Change in Skin Quality Rating Scale
Wrinkle assessment

Trial Safety

Trial Design

3 Treatment Groups

PRP
1 of 3
combined HA with PRP
1 of 3
Placebo
1 of 3
Active Control
Experimental Treatment
Non-Treatment Group

65 Total Participants · 3 Treatment Groups

Primary Treatment: Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3) · Has Placebo Group · Phase < 1

combined HA with PRP
Device
Experimental Group · 1 Intervention: Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3) · Intervention Types: Device
PRP
Other
ActiveComparator Group · 1 Intervention: PRP Only · Intervention Types: Other
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks after treatment 1st, 2nd and 3rd treatments and 32 weeks after enrollment
Closest Location: University of Minnesota · Minneapolis, MN
Photo of University of Minnesota  1Photo of University of Minnesota  2Photo of University of Minnesota 3
1993First Recorded Clinical Trial
1 TrialsResearching Wrinkles
830 CompletedClinical Trials

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,227 Previous Clinical Trials
1,454,338 Total Patients Enrolled
Maria Hordinsky, MDPrincipal InvestigatorUniversity of Minnesota
15 Previous Clinical Trials
353 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 30 to 65 years old.
Subjects with moderate to severe nasolabial folds contour deficiencies or other facial wrinkles
Subjects who agree not to have any other procedures of affecting skin quality (microdermabrasion, peels, acne treatments, toxin, fillers etc.) for the duration of the study.
Subjects who understand the study and are willing to attend the required study visits.
Subjects who agree to be photographed for research purposes and their identity may not be concealed in these photographs.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.