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 range
22 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. 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.
Timeframe: Month 2 after the last treatment
8
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