BCT-HA Kit for Wrinkles

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the Cellular Matrix BCT-HA Kit to evaluate its effectiveness in reducing wrinkles and rejuvenating skin, particularly in the midface area. The study compares this treatment to a placebo (a harmless saline solution) and another option called PRP (platelet-rich plasma, which uses components of the participant's own blood). Participants should have noticeable midface wrinkles, such as deep smile lines, and must not be undergoing any other skin treatments. The trial will also monitor for any side effects and changes in skin tissue. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Cellular Matrix TM BCT-HA Kit, which combines hyaluronic acid (a substance that helps keep skin moist) with platelet-rich plasma (PRP), is generally safe. One study used this combination for facial treatments without major safety issues. The body absorbs the hyaluronic acid in the kit in about 30 days, reducing long-term risks.

For PRP treatment alone, studies indicate it is usually safe, with minor side effects like pain, redness, and swelling at the injection site. These effects are common and typically resolve quickly. However, some reports suggest that the safety of PRP is still under investigation, so it's important to keep this in mind.

Overall, both the combined treatment and PRP alone have demonstrated good safety in research, but individual reactions can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Cellular Matrix TM BCT-HA Kit for wrinkles because it combines hyaluronic acid (HA) with platelet-rich plasma (PRP), offering a dual-action approach. Unlike traditional fillers that only provide volume, this combination not only plumps the skin but also stimulates natural healing processes to rejuvenate the skin from within. The addition of PRP is believed to enhance collagen production, potentially delivering longer-lasting and more natural-looking results compared to standard treatments. This innovative blend aims to achieve smoother, firmer skin with fewer treatments and less downtime.

What evidence suggests that this trial's treatments could be effective for wrinkles?

Research has shown that the Cellular MatrixTM BCT-HA Kit, which combines hyaluronic acid and platelet-rich plasma (PRP), effectively improves skin quality and reduces wrinkles. Participants in this trial may receive this combination treatment, which studies have found significantly enhances overall facial appearance compared to using PRP or hyaluronic acid alone. In one study, more than 50% of participants saw skin improvement just four weeks after treatment.

Another group in this trial will receive PRP alone. Research indicates that PRP can noticeably enhance facial features after just one to three sessions. Improvements often appear in areas like dark circles, wrinkles around the eyes, and smile lines. Specifically, about 56% of patients experienced better midface volume after PRP treatment. ^{1 2 3 5 6}

Who Is on the Research Team?

Maria Hordinsky, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05514834

BCT-HA Kit for Dehydrated and Wrinkled Skin This study will assess the efficacy of Cellular MatrixTM BCT-HA Kit treatment compared to placebo condition on revitalization and skin rejuvenation on the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05514834?tab=table

BCT-HA Kit for Dehydrated and Wrinkled Skin | ... This study will assess the efficacy of Cellular MatrixTM BCT-HA Kit treatment compared to placebo condition on revitalization and skin rejuvenation on the ...

3. withpower.com withpower.com/trial/early-phase-1-wrinkles-8-2022-b8cc3

BCT-HA Kit for Wrinkles · Info for Participants 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 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33534905/

Synergistic Effects of Autologous Platelet-Rich Plasma and ... Treatment with Cellular Matrix led to a very significant improvement in the overall facial appearance compared with treatment with a-PRP or HA ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12179424/

Clinical Analysis of PRP Combined With Hyaluronic Acid ... Results. The effective rate of chloasma treatment in the PRP group and the PRP+HA group was more than 50% at 4 weeks after treatment. The ...

6. regenlab.com regenlab.com/wp-content/uploads/2022/10/Patient-Information-Leaflet-for-Cellular-Matrix-BCT-HA-v.1.0.pdf

Patient Information Leaflet for Cellular Matrix BCT-HA The hyaluronic acid in the PRP/HA combination is a resorbable implant; following injection, the resorption time of hyaluronic acid is less than 30 days. Page 3 ...