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Completed

NCT Number: NCT05514834

BCT-HA Kit for Dehydrated and Wrinkled Skin

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.

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Key information

Conditions

Rhytides Wrinkle

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Injections with platelet-rich plasma and hyaluronic acid

PRP Only

Other

platelet rich plasma without hyaluronic acid

Placebo

Other

Neither PRP nor hyaluronic acid

Primary outcomes

  1. Change in Skin Quality Rating Scale

    Time frame: Week 32

    Skin Quality Rating Scale is a 10 point scales used to assess skin quality, including radiance, smoothness, pigmentation, erythema, and pore size.

  2. Change in Global Aesthetic Improvement Scale

    Time frame: Week 32

    This is a 7 point scale to assess degree of improvement of facial skin after treatment.

  3. Change in FACE-Q Score

    Time frame: 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

  4. Physician's Global assessment to measure quality of life

    Time frame: 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.

  5. Visual Analog Score for patients

    Time frame: Immediately after 1st, 2nd and 3rd treatments

    Visual analog rating of pain associated with treatment administration ranging between 0 and 10, pain scale.

  6. Wrinkle assessment

    Time frame: Week 32

    Wrinkle Assessment Score is a 9 point scale to asses severity of wrinkles.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 24, 2022
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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