What side effects are associated with this type of intervention?

Common treatments for wrinkles that involve hyaluronic acid and biological components, such as the Cellular MatrixTM BCT-HA Kit, include injectable soft tissue fillers. Known side effects of these treatments can include immediate reactions like redness, swelling, and bruising at the injection site. Late and delayed onset adverse effects may include the formation of nodules, granulomatous or other inflammatory reactions, chronic infections, and filler migration. In rare cases, vascular occlusion can occur, leading to tissue necrosis. Proper patient selection and thorough discussion of risks and expected outcomes with a healthcare provider are essential to minimize these risks.

What prior FDA approvals exist?

The FDA has approved several treatments for wrinkles that involve hyaluronic acid, a key component in skin rejuvenation. Notable examples include Restylane and Juvederm, which are hyaluronic acid-based dermal fillers used to smooth wrinkles and add volume to the skin. These treatments work by injecting hyaluronic acid into the skin, which attracts water and provides a plumping effect, reducing the appearance of wrinkles. Additionally, treatments like Sculptra, which contains poly-L-lactic acid, stimulate collagen production to improve skin texture and firmness over time. These FDA-approved treatments are similar to the Cellular MatrixTM BCT-HA Kit, which combines hyaluronic acid with other biological components for enhanced skin rejuvenation.

What other types of research exist?

Promising alternatives to Cellular MatrixTM BCT-HA Kit for wrinkle treatment include: 1) Calcium hydroxylapatite gel (Radiesse), which has been used for facial contour deficiencies and has shown long-term durability. 2) Poly-L-lactic acid (Sculptra), which has demonstrated long-term safety and efficacy in treating facial lipoatrophy and aging-related lipoatrophy. 3) Polyalkylimide gel (Bio-Alcamid), which has been used for facial augmentation with a good safety profile. 4) Polyacrylamide hydrogel, which has shown efficacy and safety in facial soft-tissue augmentation over a two-year follow-up period.

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Device

BCT-HA Kit for Wrinkles

Q: What is the mechanism of action of this treatment?

The Cellular MatrixTM BCT-HA Kit combines biological components and hyaluronic acid to rejuvenate the skin by enhancing hydration and stimulating collagen production. Hyaluronic acid, a naturally occurring substance in the skin, helps to retain moisture and add volume, thereby reducing the appearance of wrinkles. Other common treatments include injectable soft tissue fillers, which provide immediate volume and support to the skin, and topical retinoic acid, which promotes cell turnover and collagen synthesis. These mechanisms are important for wrinkle patients as they address both the superficial and structural aspects of aging skin, leading to a more youthful and elastic appearance.

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks after treatment 1st, 2nd and 3rd treatments and 32 weeks after enrollment

Summary

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.

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+.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks after treatment 1st, 2nd and 3rd treatments and 32 weeks after enrollment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Cellular MatrixTM BCT-HA Kit combines biological components and hyaluronic acid to rejuvenate the skin by enhancing hydration and stimulating collagen production. Hyaluronic acid, a naturally occurring substance in the skin, helps to retain moisture and add volume, thereby reducing the appearance of wrinkles. Other common treatments include injectable soft tissue fillers, which provide immediate volume and support to the skin, and topical retinoic acid, which promotes cell turnover and collagen synthesis. These mechanisms are important for wrinkle patients as they address both the superficial and structural aspects of aging skin, leading to a more youthful and elastic appearance.

Topical retinoic acid treatment of photoaged skin: its effects on hyaluronan distribution in epidermis and on hyaluronan and retinoic acid in suction blister fluid.A novel, volumizing cosmetic formulation significantly improves the appearance of target Glabellar lines, nasolabial folds, and crow's feet in a double-blind, vehicle-controlled clinical trial.