RhytidesEarly Phase 1NCT05514834
BCT-HA Kit for Dehydrated and Wrinkled Skin
A Early Phase 1 study testing Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3) and PRP Only in people with Rhytides and Wrinkle, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3) and PRP Only
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2022to 29 Feb 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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)
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.
- Being tested
- Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3), PRP Only, Placebo
- Keywords
- rhytides, wrinkles, facial aging, PRP, hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3)Device
Injections with platelet-rich plasma and hyaluronic acid
PRP OnlyOther
platelet rich plasma without hyaluronic acid
PlaceboOther
Neither PRP nor hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| combined HA with PRP | Experimental | Hyaluronic acid and PRP combination treatment Receives: Device: Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3) |
| Placebo | Placebo comparator | saline solution Receives: Other: Placebo |
| PRP | Active comparator | Platelet rich plasma without hyaluronic acid Receives: Other: PRP Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 32
Change in Global Aesthetic Improvement Scale
This is a 7 point scale to assess degree of improvement of facial skin after treatment.
Measured: Week 32
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
Measured: Week 32
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.
Measured: 4 weeks after treatment 1st, 2nd and 3rd treatments and 32 weeks after enrollment
Visual Analog Score for patients
Visual analog rating of pain associated with treatment administration ranging between 0 and 10, pain scale.
Measured: Immediately after 1st, 2nd and 3rd treatments
Wrinkle assessment
Wrinkle Assessment Score is a 9 point scale to asses severity of wrinkles.
Measured: Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start10 Jun 2022
- Primary completion1 Oct 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhytidesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blinded, randomized control trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Hordinsky, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514834
- Sponsor's protocol ID
- DERM-2021-30292
- Status last verified
- Apr 2024
- First submitted
- 25 Jul 2022
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05514834
- Acronym / sponsor ID
- DERM-2021-30292
- Keywords
- rhytides, wrinkles, facial aging, PRP, hyaluronic acid
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Blinded, randomized control trial
| Arm | Type | Receives |
|---|---|---|
| combined HA with PRP | Experimental | Device: Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3)Hyaluronic acid and PRP combination treatment |
| Placebo | Placebo comparator | Other: Placebosaline solution |
| PRP | Active comparator | Other: PRP OnlyPlatelet rich plasma without hyaluronic acid |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3)Injections with platelet-rich plasma and hyaluronic acid | Device | combined HA with PRP |
| PRP Onlyplatelet rich plasma without hyaluronic acid | Other | PRP |
| PlaceboNeither PRP nor hyaluronic acid | Other | Placebo |
Primary outcome
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.
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.
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
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.
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.
Wrinkle assessment
Time frame: Week 32
Wrinkle Assessment Score is a 9 point scale to asses severity of wrinkles.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Hordinsky, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3) and PRP Only in people with Rhytides and Wrinkle, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skin Quality Rating Scale (time frame: Week 32). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.