BCT-HA Kit for Wrinkles

Recruiting at -1 trial locations

Overseen By Irmina Wallander

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Minnesota

Disqualifiers: Diabetes, Immunosuppressed, HIV+, others

Compensation: Varies

Number of Visits: 4

Duration: 32 weeks

65 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test a new skin treatment called Cellular MatrixTM BCT-HA Kit to see if it can make the midface look younger and healthier. It will also check for any safety issues.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not have had certain aesthetic treatments recently and should not have certain skin conditions or allergies.

What data supports the effectiveness of the BCT-HA Kit treatment for wrinkles?

Research shows that hyaluronic acid (a component of the BCT-HA Kit) is effective in improving skin quality and reducing facial lines, as seen in studies where it was used for facial revitalization and treating facial wrinkles. ^{1 2 3 4 5}

How is the BCT-HA Kit for Wrinkles different from other treatments?

The BCT-HA Kit for Wrinkles is unique because it combines hyaluronic acid (a substance that helps keep skin hydrated) with other components in a specific formulation designed to improve skin quality and reduce wrinkles. This combination is different from standard treatments, which may not use this specific blend or method of application. ^{1 2 3 4 6}

Research Team

Maria Hordinsky, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

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+.

Inclusion Criteria

People who are in good health and are between 30 and 65 years old.

People with any skin type from very fair to very dark can participate.

You have moderate to severe wrinkles on your face, especially around the nose and mouth.

Exclusion Criteria

You have received or will receive a COVID vaccine within 2 weeks of the study.

You had any cosmetic treatments on your face in the last 6 months, like peeling, laser, ultrasound, toxins, or fillers.

You cannot use certain antiseptic medications like Biseptine or Amukine for medical reasons.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cellular MatrixTM BCT-HA Kit treatment or placebo for skin rejuvenation

32 weeks

3 treatments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3)
• Placebo
• PRP Only

Trial Overview 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.

Participant Groups

Group I: combined HA with PRP Experimental Treatment 1 Intervention

Hyaluronic acid and PRP combination treatment

Group II: PRP Active Control 1 Intervention

Platelet rich plasma without hyaluronic acid

Group III: Placebo Placebo Group 1 Intervention

saline solution

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Consensus on the Use of Hyaluronic Acid Fillers from the Cohesive Polydensified Matrix Range: Best Practice in Specific Facial Indications. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Facial Skin Revitalization with Cohesive Polydensified Matrix-HA20G: Results from a Randomized Multicenter Clinical Study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Evaluating an incobotulinumtoxinA and Cohesive Polydensified Matrix&#174; hyaluronic acid filler combination to treat moderate-to-severe periorbital and perioral rhytids. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Microinjections with hyaluronic acid in combination with glycerol: How do they influence biophysical viscoelastic skin properties? [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Cohesive Polydensified Matrix&#174; hyaluronic acid volumizer injected for cheek augmentation has additional positive effect on nasolabial folds. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Ingestion of BioCell Collagen(®), a novel hydrolyzed chicken sternal cartilage extract; enhanced blood microcirculation and reduced facial aging signs. [2021]