Back to resultsBCT-HA Kit for Dehydrated and Wrinkled Skin
Primary Purpose
Rhytides, Wrinkle
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3)
PRP Only
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rhytides focused on measuring rhytides, wrinkles, facial aging, PRP, hyaluronic acid
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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
combined HA with PRP
Placebo
PRP
Arm Description
Hyaluronic acid and PRP combination treatment
saline solution
Platelet rich plasma without hyaluronic acid
Outcomes
Primary Outcome Measures
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.
Change in Global Aesthetic Improvement Scale
This is a 7 point scale to assess degree of improvement of facial skin after treatment.
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
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.
Visual Analog Score for patients
Visual analog rating of pain associated with treatment administration ranging between 0 and 10, pain scale.
Wrinkle assessment
Wrinkle Assessment Score is a 9 point scale to asses severity of wrinkles.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05514834
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhytides, Wrinkle
Keywords
rhytides, wrinkles, facial aging, PRP, hyaluronic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Blinded, randomized control trial
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
combined HA with PRP
Arm Type
Experimental
Arm Description
Hyaluronic acid and PRP combination treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
saline solution
Arm Title
PRP
Arm Type
Active Comparator
Arm Description
Platelet rich plasma without hyaluronic acid
Intervention Type
Device
Intervention Name(s)
Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3)
Intervention Description
Injections with platelet-rich plasma and hyaluronic acid
Intervention Type
Other
Intervention Name(s)
PRP Only
Intervention Description
platelet rich plasma without hyaluronic acid
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Neither PRP nor hyaluronic acid
Primary Outcome Measure Information:
Title
Change in Skin Quality Rating Scale
Description
Skin Quality Rating Scale is a 10 point scales used to assess skin quality, including radiance, smoothness, pigmentation, erythema, and pore size.
Time Frame
Week 32
Title
Change in Global Aesthetic Improvement Scale
Description
This is a 7 point scale to assess degree of improvement of facial skin after treatment.
Time Frame
Week 32
Title
Change in FACE-Q Score
Description
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
Time Frame
Week 32
Title
Physician's Global assessment to measure quality of life
Description
Patient rating of improvement in treated area ranging from 1 to 5, with 5 being worse.
Time Frame
4 weeks after treatment 1st, 2nd and 3rd treatments and 32 weeks after enrollment
Title
Visual Analog Score for patients
Description
Visual analog rating of pain associated with treatment administration ranging between 0 and 10, pain scale.
Time Frame
Immediately after 1st, 2nd and 3rd treatments
Title
Wrinkle assessment
Description
Wrinkle Assessment Score is a 9 point scale to asses severity of wrinkles.
Time Frame
Week 32
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Hordinsky, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
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BCT-HA Kit for Dehydrated and Wrinkled Skin
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