Clinical trial NCT05514834: BCT-HA Kit for Dehydrated and Wrinkled Skin
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Rhytides
Wrinkle
Keywords: rhytides
wrinkles
facial aging
PRP
hyaluronic acid
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blinded, randomized control trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Skin Quality Rating Scale
timeFrame: Week 32
measure: Change in Global Aesthetic Improvement Scale
timeFrame: Week 32
measure: Change in FACE-Q Score
timeFrame: Week 32
measure: Physician's Global assessment to measure quality of life
timeFrame: 4 weeks after treatment 1st, 2nd and 3rd treatments and 32 weeks after enrollment
measure: Visual Analog Score for patients
timeFrame: Immediately after 1st, 2nd and 3rd treatments
measure: Wrinkle assessment
timeFrame: Week 32
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Maria Hordinsky, MD
role: PRINCIPAL_INVESTIGATOR
References: