BCT-HA Kit for Dehydrated and Wrinkled Skin

NCT ID: NCT05514834

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-10
• Study Completion Date: 2024-02-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

combined HA with PRP

Hyaluronic acid and PRP combination treatment

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Injections with platelet-rich plasma and hyaluronic acid

Placebo

saline solution

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Neither PRP nor hyaluronic acid

PRP

Platelet rich plasma without hyaluronic acid

Group Type: ACTIVE_COMPARATOR

PRP Only

Intervention Type: OTHER

platelet rich plasma without hyaluronic acid

Interventions

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

Injections with platelet-rich plasma and hyaluronic acid

Intervention Type: DEVICE

PRP Only

platelet rich plasma without hyaluronic acid

Intervention Type: OTHER

Placebo

Neither PRP nor hyaluronic acid

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Hordinsky, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

DERM-2021-30292

Identifier Type: -

Identifier Source: org_study_id