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BCT-HA Kit for Dehydrated and Wrinkled Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05514834
Recruitment Status : Recruiting
First Posted : August 24, 2022
Last Update Posted : March 7, 2023
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rhytides Wrinkle Device: Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3) Other: PRP Only Other: Placebo Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blinded, randomized control trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The participant, investigator, and dermatopathologist (outcomes assessor) will all be blinded to which group the participant belongs too. Given the color difference of the injected solutions, the syringes with the injection material (HA with PRP or saline) will be masked to prevent the patient or investigator from knowing which material they are injecting.
Primary Purpose: Treatment
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)
Actual Study Start Date : June 10, 2022
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dehydration

Arms and Interventions
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Arm Intervention/treatment
Experimental: combined HA with PRP
Hyaluronic acid and PRP combination treatment
 Device: Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3)
Injections with platelet-rich plasma and hyaluronic acid
Placebo Comparator: Placebo
saline solution
 Other: Placebo
Neither PRP nor hyaluronic acid
Active Comparator: PRP
Platelet rich plasma without hyaluronic acid
 Other: PRP Only
platelet rich plasma without hyaluronic acid


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05514834


Contacts
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Contact: Irmina Wallander 612-624-5721 dermresearch@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Irmina Wallander    612-624-5721    dermresearch@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Maria Hordinsky, MD University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT05514834    
Other Study ID Numbers: DERM-2021-30292
First Posted: August 24, 2022    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by University of Minnesota:
rhytides
wrinkles
facial aging
PRP
hyaluronic acid
Additional relevant MeSH terms:
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Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes