BCT-HA Kit for Dehydrated and Wrinkled Skin

Feasibility Study to Evaluate the Safety and Efficacy of Cellular MAtrix™ BCT-HA Kit as a New Treatment Option for Dehydrated and Wrinkled Skin (A Clinical and Histological Evaluation)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Wrinkle; Rhytides
• Intervention / Treatment: Device: Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3); Other: Placebo; Other: PRP Only

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Irmina Wallander; Phone Number: 612-624-5721; Email: dermresearch@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained including HIPPA Authorization
• Healthy men and women, ages 30 - 65 years of age
• Subjects with Fitzpatrick photo skin type I-VI
• Subjects with moderate to severe nasolabial folds contour deficiencies or other facial wrinkles. Degree of nasolabial folds or other facial wrinkles will be determined on the basis of the Wrinkles Severity Rating Scale
• 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 able to follow study instructions 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.

Exclusion Criteria:

• Subjects who have had any kind of aesthetic therapy (peeling, laser, ultrasound, toxins, fillers) in the facial area during the last 6 months
• Presence of implant in the facial area to treat
• Contraindications to the use of antiseptics (Biseptine, Amukine)
• Subjects who have an active or known skin inflammation or infection within the treatment area.
• Subjects who have an active or known acute skin allergies
• Subjects who have a known allergy to hyaluronic acid
• Subjects who have any other dermatologic conditions including acne, rosacea, eczema, psoriasis, actinic keratosis, severe sun damage, infection, or scars within the treatment area.
• Subjects of child-bearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy, or bilateral oophorectomy.
• Subjects who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy.
• Subjects who have been diagnosed with diabetes
• Subjects who are Immunosuppressed
• Subjects who are HIV+ / VHB+ / VHC+
• Subjects who have had/will have a COVID vaccine within 2 weeks of study participation
• Subjects who have had/will have a dental procedure within 4 weeks of study participation
• Subjects with a history of severe bee allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; saline solution	Other: Placebo; Neither PRP nor hyaluronic acid
Experimental: combined HA with PRP; Hyaluronic acid and PRP combination treatment	Device: Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3); Injections with platelet-rich plasma and hyaluronic acid
Active Comparator: PRP; Platelet rich plasma without hyaluronic acid	Other: PRP Only; platelet rich plasma without hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Skin Quality Rating Scale	Skin Quality Rating Scale is a 10 point scales used to assess skin quality, including radiance, smoothness, pigmentation, erythema, and pore size.	Week 32
Change in Global Aesthetic Improvement Scale	This is a 7 point scale to assess degree of improvement of facial skin after treatment.	Week 32
Change in FACE-Q Score	The following eight FACE-Q scales: (1) satisfaction with overall facial appearance (measures patient satisfaction with the overall appearance of their face); (2) satisfaction with decision (measures patient satisfaction with their decision to undergo the procedure;(3) cheekbones; (4) chin; (5) cheeks; (6) lower face; (7) jawline; and (8) nasolabial folds (items 3 through 8 measure overall and area-specific appearance appraisal to evaluate satisfaction with specific facial areas). Higher FACE-Q scores indicate superior satisfaction	Week 32
Physician's Global assessment to measure quality of life	Patient rating of improvement in treated area ranging from 1 to 5, with 5 being worse.	4 weeks after treatment 1st, 2nd and 3rd treatments and 32 weeks after enrollment
Visual Analog Score for patients	Visual analog rating of pain associated with treatment administration ranging between 0 and 10, pain scale.	Immediately after 1st, 2nd and 3rd treatments
Wrinkle assessment	Wrinkle Assessment Score is a 9 point scale to asses severity of wrinkles.	Week 32

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Maria Hordinsky, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: wrinkles; hyaluronic acid; PRP; rhytides; facial aging
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: DERM-2021-30292

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes