BCT-HA Kit for Dehydrated and Wrinkled Skin

Sponsor

University of Minnesota (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05514834

Collaborator

(none)

Enrollment

Location

Arms

4.9

Anticipated Duration (Months)

13.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhytides Wrinkle	Device: Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3) Other: PRP Only Other: Placebo	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Blinded, randomized control trialBlinded, randomized control trial

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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)

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jan 28, 2023

Anticipated Study Completion Date :

Jan 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: Placebo saline solution	Other: Placebo Neither PRP nor hyaluronic acid
Active Comparator: PRP Platelet rich plasma without hyaluronic acid	Other: PRP Only platelet rich plasma without hyaluronic acid

Arm

Intervention/Treatment

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

Placebo Comparator: Placebo

saline solution

Other: Placebo

Neither PRP nor hyaluronic acid

Active Comparator: PRP

Platelet rich plasma without hyaluronic acid

Other: PRP Only

platelet rich plasma without hyaluronic acid

Outcome Measures

Primary Outcome Measures

Change in Skin Quality Rating Scale [Week 32]
Skin Quality Rating Scale is a 10 point scales used to assess skin quality, including radiance, smoothness, pigmentation, erythema, and pore size.
Change in Global Aesthetic Improvement Scale [Week 32]
This is a 7 point scale to assess degree of improvement of facial skin after treatment.
Change in FACE-Q Score [Week 32]
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
Physician's Global assessment to measure quality of life [4 weeks after treatment 1st, 2nd and 3rd treatments and 32 weeks after enrollment]
Patient rating of improvement in treated area ranging from 1 to 5, with 5 being worse.
Visual Analog Score for patients [Immediately after 1st, 2nd and 3rd treatments]
Visual analog rating of pain associated with treatment administration ranging between 0 and 10, pain scale.
Wrinkle assessment [Week 32]
Wrinkle Assessment Score is a 9 point scale to asses severity of wrinkles.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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