Preliminary Safety and Effectiveness of SMI-01 as a Tissue Filler

NCT04534660 | Completed FDA Device

• 1 other identifier: SOF-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Nasolabial Fold; Cheek Augmentation

Outcome Measures

Primary Outcomes (9)

• 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)

  The Investigator will assess overall ease of use by the device by circling the appropriate number on the Numerical Rating Scale (NRS) from 0 being not easy to 10 being most easy.

  Initial Treatment, Day 1

• Patient reported incidence of CTR's and any treatment emergent adverse events

  Subject self-evaluation of Common treatment site responses (CTR's) and any treatment emergent adverse events as recorded in the Subject's 30-day diary. A diary will be dispensed to record CTR's responses such as erythema, tenderness, moderate swelling, pruritus or any allergic symptoms or possible systemic reaction such as a rash, arthralgia, myalgia that occurs at any time during the observation period.

  Day 30

• Patient reported severity (mild, moderate or severe) of CTR's and any treatment emergent adverse events

  Subject self-evaluation of Common treatment site responses (CTR's) and any treatment emergent adverse events as recorded in the Subject's 30-day diary. A diary will be dispensed to record CTR's responses such as erythema, tenderness, moderate swelling, pruritus or any allergic symptoms or possible systemic reaction such as a rash, arthralgia, myalgia that occurs at any time during the observation period.

  Day 30

• Patient reported duration of CTR's and any treatment emergent adverse events

  Subject self-evaluation of Common treatment site responses (CTR's) and any treatment emergent adverse events as recorded in the Subject's 30-day diary. A diary will be dispensed to record CTR's responses such as erythema, tenderness, moderate swelling, pruritus or any allergic symptoms or possible systemic reaction such as a rash, arthralgia, myalgia that occurs at any time during the observation period.

  Day 30

• Investigator reported incidence of CTR's and any treatment-emergent adverse events

  The Treating Investigator will evaluate Common treatment site responses (CTR's) and any treatment emergent adverse events at the in-clinic visit.

  Month 2 after the last treatment

• Investigator reported duration of Common treatment site responses (CTR's) and any treatment-emergent adverse events

  The Treating Investigator will evaluate and document the subject's safety response to the Silk Restore treatment.

  Month 2 after the last treatment

• Investigator reported severity (mild, moderate or severe) of Common treatment site responses (CTR's) and any treatment-emergent adverse events

  The Treating Investigator will evaluate and document the subject's safety response to the Silk Restore treatment.

  Month 2 after the last treatment

• Change in midface volume retention measured by Sofregen's Midface Volume Scale (MFVS) for Cheek Augmentation subjects only

  Preliminary evaluation of the effectiveness of SMI-01 will be determined by the Treating Investigator's score of the subject's treatment using Sofregen's proprietary MFVS scale. The MFVS measures midface volume loss on a scale of 0 (none to minimal) to 3 (severe).

  Month 2 after the last treatment

• Change in wrinkle severity measured by Wrinkle Severity Rating Scale (WSRS) for Nasolabial fold correction subjects only

  Preliminary evaluation of the effectiveness of SMI-01 will be determined by the Treating Investigator's score of the subject's treatment using the WSRS. The WSRS measures wrinkle severity on a scale of 1 (absent) to 5 (extreme).

  Month 2 after the last treatment

Study Arms (2)

Nasolabial Fold

EXPERIMENTAL

SMI-01 is an injectable device comprising silk particles distributed in a hydrogel carrier. The intervention will be administed once, at the Day 1 visit. An optional touch-up treatment is allowed at the Day 30 visit. The study treatment facial areas are the Right and Left nasolabial fold. The Treating Investigator will inject SMI-01 into the mid to deep dermis for correction of moderate to severe wrinkle and folds. The Treating Investigator will determine the appropriate volume of SMI-01 to be injected during initial and touch-up treatment(s).

Device: SMI-01

Cheek Augmentation

EXPERIMENTAL

SMI-01 is an injectable device comprising silk particles distributed in a hydrogel carrier. The intervention will be administed once, at the Day 1 visit. An optional touch-up treatment is allowed at the Day 30 visit. The midface constitutes the area of the face below the eyes and between the nose and the left or right ear. The study treatment facial areas are the Right and Left cheeks. The Treating Investigator will inject SMI-01 deeply (subcutaneous and/or supraperiosteal plane) for cheek augmentation to correct age-related volume deficiency in the midface, i.e., zygomaticomalar region, anteromedial cheek, and/or submalar region

Device: SMI-01

Interventions

SMI-01 DEVICE

SMI-01 is a device consisting of silk particles in a hydrogel carrier.

Cheek Augmentation; Nasolabial Fold

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Cheek Augmentation:
• \. Seeking augmentation therapy for the midface with a Midface Volume Scale (MFVS) score of a 1 (mild loss midface volume loss and or presence of mild concavity) or 2 (moderate midface volume loss and/or presence of moderate concavity) on each side of the face as assessed by the Treating Investigator.
• \. Accept the obligation not to receive any other facial procedures or treatments affecting facial volume deficit at any time during the study.
• Nasolabial Fold Correction:
• \. Seeking augmentation therapy for the nasolabial folds with two fully visible nasolabial folds with Wrinkle Severity Rating Scale score of 3 or 4 (moderate or severe).
• \. Accepts the obligation not to receive any other facial procedures or treatments affecting facial nasolabial fold deficit at any time during the study.

You may not qualify if:

• 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.
• Subjects who used deoxycholic acid treatment or other fat-reducing agents within 12 months prior to study treatment and throughout the study.
• Subjects who have undergone mesotherapy, highintensity focused ultrasound (HIFU), high-intensity focused electromagnetic energy (HIFEM), or any other Energy Based Devices on the face within 12 months of the study and throughout the study. This also includes all intense pulsed light treatments, lasers (all), and RF treatments of any kind, photodynamic therapy, photomodulation with low level light sources (including laser light).
• Subjects who have undergone facial treatment with a non-HA tissue filler (e.g., collagen, calcium hydroxylapatite, Poly-L-lactic Acid) within 18 months prior to study treatment and throughout the study.
• Subjects who have ever undergone facial plastic surgery, tissue grafting, or received permanent facial implants (e.g., polymethyl methacrylate, polyacrylamide, silicone, fat transfer procedures or adipose matrix products, polytetrafluoroethylene, lifting threads, absorbable sutures) anywhere in the face or neck, or is planning to be implanted with any of these products during the course of the study.
• Evidence of scar-related disease or delayed healing activity within the past 12 months.
• Evidence of scar at the intended treatment region on the face.
• History of keloid formation or hypertrophic scars.

Sponsors & Collaborators

• Sofregen Medical, Inc.: lead
• Symbio, LLC: collaborator

Study Sites (2)

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Baumann Cosmetic & Research Institute

Miami, Florida, 33137, United States

Location

Study Officials

• Leslie S. Baumann, MD

  Baumann Cosmetic & Research Institute

  PRINCIPAL INVESTIGATOR

• Stacy Smith, MD

  California Dermatology & Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This FDA approved feasibility study model includes 2 single groups, one for each indication (Cheek augmentation N=15; Nasolabial Fold Correction N=15). Both will receive the same treatment (SMI-01). Findings from the feasibility study will be used to inform study design for the Pivotal study.

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: September 1, 2020
• Study Start: November 10, 2020
• Primary Completion: August 24, 2021
• Study Completion: June 23, 2023
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)