Preliminary Safety and Effectiveness of SMI-01 as a Tissue Filler (NCT04534660) | Clinical Trial Compass
CompletedNot Applicable
Preliminary Safety and Effectiveness of SMI-01 as a Tissue Filler
United States21 participantsStarted 2020-11-10
Plain-language summary
Multicenter (two clinical sites), unblinded, no control group, prospective feasibility study. Subject participation may last up to 24 months after enrollment. Treatment will be performed at Day 1 and optionally at Day 30, with the primary safety and effectiveness evaluation at 2 months. Subjects will continue extended follow-up evaluations at 4, 6, 12, 18 and 24 months after the final injection.
The duration and follow-up schedule will be identical, independent of treatment performed.
Who can participate
Age range22 Years – 65 Years
SexALL
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Inclusion criteria
✓. Males or non-pregnant, non-breastfeeding females, 22 to 65 years old.
✓. Sign the Informed Consent form and the Authorization for Use and Release HIPAA form prior to any study-related procedures being performed.
✓. Willing to comply with the requirements of the study, including sequential photography or imaging; willing to abstain from any plastic surgical or cosmetic procedures of the head or neck for the 24 months of the study (including but not limited to laser or chemical resurfacing, facelift, and other filler treatments).
✓. Willing to avoid any intentional changes in weight, and avoid initiating any strict weight loss or weight gain programs.
✓. Agrees to refrain from seeking other treatment for the treated condition during thestudy.
✓. If the subject is a female of childbearing potential (sexually active and not sterile nor postmenopausal for at least 1 year), she must have a negative urine pregnancy test have used an acceptable contraception method for at least 30 days prior to enrollment, and agree to use an acceptable method of contraception for the duration of the study. The following are considered acceptable methods of birth control for the purpose of this study: oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive (NuvaRing®), double barrier methods (e.g., condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD (Mirena®), and abstinence with a documented second acceptable method of birth control if the subject becomes sexually active.
Exclusion criteria
✕. Female subjects who are pregnant, breastfeeding, intending to become pregnant during the study, or who do not agree to use an acceptable form of birth control during the study.
What they're measuring
1
To obtain clinician feedback on overall ease of use of device on a scale of 0 -10 (0 being not easy and 10 being most easy)
Timeframe: Initial Treatment, Day 1
2
Patient reported incidence of CTR's and any treatment emergent adverse events
Timeframe: Day 30
3
Patient reported severity (mild, moderate or severe) of CTR's and any treatment emergent adverse events
Timeframe: Day 30
4
Patient reported duration of CTR's and any treatment emergent adverse events
Timeframe: Day 30
5
Investigator reported incidence of CTR's and any treatment-emergent adverse events
Timeframe: Month 2 after the last treatment
6
Investigator reported duration of Common treatment site responses (CTR's) and any treatment-emergent adverse events
Timeframe: Month 2 after the last treatment
7
Investigator reported severity (mild, moderate or severe) of Common treatment site responses (CTR's) and any treatment-emergent adverse events
✕. Subjects who have a body mass index (BMI) of ≥ 30.
✕. A history of allergy or hypersensitivity to injectable hyaluronic acid gel.
✕. A history of allergy or hypersensitivity to silk.
✕. Presentation on the face of any of the following: cysts, acne, rosacea, rashes or hives, infection, psoriasis, herpes zoster, actinic keratosis or any other disease that , in the opinion of the investigator, may result in changes in facial contour, edema of the face or otherwise interfere with study assessments.
✕. Subjects who have undergone the following: 1) chemical peels, 2) microdermabrasion, 3) dermabrasion, or 4) needling procedures anywhere on the face or neck within 6 months prior to study treatment and throughout the study.
✕. Subjects who received injectable neurotoxins on the face or neck area within 6 months prior to study treatment and throughout the study.
✕. Subjects who have undergone facial treatment with a hyaluronic acid (HA) tissue filler within 12 months prior to study treatment and throughout the study.
Change in midface volume retention measured by Sofregen's Midface Volume Scale (MFVS) for Cheek Augmentation subjects only
Timeframe: Month 2 after the last treatment
9
Change in wrinkle severity measured by Wrinkle Severity Rating Scale (WSRS) for Nasolabial fold correction subjects only