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Device

BCT-HA Kit for Wrinkles

Phase < 1
Waitlist Available
Led By Maria Hordinsky, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy men and women, ages 30 - 65 years of age
Subjects with Fitzpatrick photo skin type I-VI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after treatment 1st, 2nd and 3rd treatments and 32 weeks after enrollment
Awards & highlights

Study Summary

This trial will test a new treatment for skin revitalization and compare it to a placebo. Safety and efficacy will be measured.

Who is the study for?
This trial is for healthy men and women aged 30-65 with moderate to severe facial wrinkles, who can consent to study procedures and attend required visits. They must not have had aesthetic treatments in the past 6 months or plan any during the study. Exclusions include recent COVID vaccine recipients, allergy to hyaluronic acid, certain contraception non-users, pregnant/breastfeeding individuals, those with diabetes or immunosuppression, active skin infections/inflammations in the treatment area, severe bee allergies, recent dental procedures or HIV+/VHB+/VHC+.Check my eligibility
What is being tested?
The trial tests Cellular MatrixTM BCT-HA Kit's effectiveness on midface rejuvenation versus PRP Only and a placebo. It focuses on safety and histological changes (skin tissue alterations) due to treatment. Participants will be randomly assigned to receive one of these interventions.See study design
What are the potential side effects?
Potential side effects may include allergic reactions specific to hyaluronic acid components used in the kit such as redness or swelling at injection sites; however detailed side effect profiles will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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People who are in good health and are between 30 and 65 years old.
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People with any skin type from very fair to very dark can participate.
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You have moderate to severe wrinkles on your face, especially around the nose and mouth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after treatment 1st, 2nd and 3rd treatments and 32 weeks after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after treatment 1st, 2nd and 3rd treatments and 32 weeks after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in FACE-Q Score
Change in Global Aesthetic Improvement Scale
Change in Skin Quality Rating Scale
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: combined HA with PRPExperimental Treatment1 Intervention
Hyaluronic acid and PRP combination treatment
Group II: PRPActive Control1 Intervention
Platelet rich plasma without hyaluronic acid
Group III: PlaceboPlacebo Group1 Intervention
saline solution

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,355 Previous Clinical Trials
1,585,972 Total Patients Enrolled
Maria Hordinsky, MDPrincipal InvestigatorUniversity of Minnesota
15 Previous Clinical Trials
353 Total Patients Enrolled

Media Library

Wrinkles Clinical Trial 2023: Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3) Highlights & Side Effects. Trial Name: NCT05514834 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research explore the effects in individuals aged 45 or above?

"This particular medical trial is recruiting adults between the ages of 30 and 65. There are 4 other trials targeting minors under 18, while 23 clinical studies have been created with elderly patients aged over 65 in mind."

Answered by AI

What characteristics make certain individuals suitable candidates for this research?

"To partake in the study, volunteers must demonstrate wrinkles and be aged between 30 to 65 years old. The trial will include a total of 65 participants."

Answered by AI

How extensive is the patient sample for this experiment?

"Affirmative. Clinicaltrials.gov outlines that this medical trial is currently welcoming participants, which were first posted on June 10th 2022 and last updated September 19th of the same year. Approximately 65 volunteers are needed from a single site."

Answered by AI

Are there any open enrolment opportunities for this research trial?

"Based on the information available, this medical trial is actively recruiting participants. It was initially posted to clinicaltrials.gov on June 10th 2022 and has been updated as recently as September 19th of that same year."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
University of Minnesota

Why did patients apply to this trial?

I'm almost 40 and I'm very interested in anything I can do to help to help people stay looking young.
PatientReceived no prior treatments
~24 spots leftby Feb 2025