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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05514834
Other study ID # DERM-2021-30292
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date June 10, 2022
Est. completion date February 29, 2024

Study information

Verified date April 2024
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date February 29, 2024
Est. primary completion date October 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3)
Injections with platelet-rich plasma and hyaluronic acid
Other:
PRP Only
platelet rich plasma without hyaluronic acid
Placebo
Neither PRP nor hyaluronic acid

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Change in Global Aesthetic Improvement Scale This is a 7 point scale to assess degree of improvement of facial skin after treatment. Week 32
Primary 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
Primary 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
Primary 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
Primary Wrinkle assessment Wrinkle Assessment Score is a 9 point scale to asses severity of wrinkles. Week 32
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