BCT-HA Kit for Dehydrated and Wrinkled Skin

NCT05514834 | Completed Early Phase 1 FDA Device

• 1 other identifier: DERM-2021-30292
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rhytides; Wrinkle

Keywords

rhytides; wrinkles; facial aging; PRP; hyaluronic acid

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (3)

combined HA with PRP

EXPERIMENTAL

Hyaluronic acid and PRP combination treatment

Device: Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3)

Placebo

PLACEBO COMPARATOR

saline solution

Other: Placebo

PRP

ACTIVE COMPARATOR

Platelet rich plasma without hyaluronic acid

Other: PRP Only

Interventions

Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3) DEVICE

Injections with platelet-rich plasma and hyaluronic acid

combined HA with PRP

PRP Only OTHER

platelet rich plasma without hyaluronic acid

PRP

Placebo OTHER

Neither PRP nor hyaluronic acid

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

• Maria Hordinsky, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant, investigator, and dermatopathologist (outcomes assessor) will all be blinded to which group the participant belongs too. Given the color difference of the injected solutions, the syringes with the injection material (HA with PRP or saline) will be masked to prevent the patient or investigator from knowing which material they are injecting.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Blinded, randomized control trial

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 24, 2022
• Study Start: June 10, 2022
• Primary Completion: October 1, 2023
• Study Completion: February 29, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

US (1)