BCT-HA Kit for Dehydrated and Wrinkled Skin

University of Minnesota (UMN)

Status and phase: Completed; Early Phase 1

Conditions: Wrinkle; Rhytides

Treatments: Device: Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3); Other: Placebo; Other: PRP Only

Study type: Interventional

Funder types: Other

Identifiers

NCT05514834

DERM-2021-30292

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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15 participants in 3 patient groups, including a placebo group

combined HA with PRP

Experimental group

Description:

Hyaluronic acid and PRP combination treatment

Treatment:

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

Placebo

Placebo Comparator group

Description:

saline solution

Treatment:

Other: Placebo

PRP

Active Comparator group

Description:

Platelet rich plasma without hyaluronic acid

Treatment:

Other: PRP Only