Histology of SMA-001 in the Abdomen

A Histologic Study of Silk Medical Aesthetics Device in the Abdomen of Patients Undergoing Abdominoplasty

Silk Medical Aesthetics' Inc. device, SMA-001, is currently under development as a dermal filler to fill wrinkles and folds. This study is designed to collect short-term visual, photographic, and histological and safety data on small aliquots of the product as part of device development. It is an open label study involving up to three investigational sites and a maximum enrollment of 10 subjects. Juvéderm Ultra Plus XC, an FDA-approved dermal filler will serve as a control device. Briefly, the investigational product and the control device will be injected into the abdomen of patients intending to undergo abdominoplasty at a later date. The patients will be followed for 30 days post injection through visual observation. At 30 days post injection, the injected gel and associated tissue will be removed via biopsy during the abdominoplasty surgery and histology slides created for analysis.

Study Overview

• Status: Completed
• Conditions: Abdominoplasty; Medical Aesthetics
• Intervention / Treatment: Device: SMA-001

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Skincare Physicians, Inc
  • Minnesota
    • Burnsville, Minnesota, United States, 55337
      • Gryskiewicz Twin Cities Cosmetic Surgery
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Jewell Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Female, 25-65 years of age
2. Abdominoplasty patients with sufficient skin quality (dermal thickness & integrity, limited stretch marks/attenuated skin)
3. Able to follow study instructions and likely to complete all required visits, as assessed by the PI
4. Signed the IRB-approved Informed Consent form and the HIPAA form prior to performance of any study-related procedures

Exclusion Criteria:

1. Subjects with intrinsic skin disease or documented dermatologic conditions
2. Subjects with known bleeding disorders or on medications that may interfere with bleeding
3. Subjects currently taking immunosuppressive drugs, steroids, or anti-inflammatories
4. Subjects receiving injection of lipolytic drugs
5. Subjects with a history of keloid formation or hypertrophic scarring
6. Subjects with documented Type I or II Diabetes Mellitus.
7. Inability or unwillingness of the subject to complete the clinical protocol as described in the protocol and allow access to clinical records.
8. Subjects who are known to be pregnant at the time of enrollment or plan to become pregnant in the coming 30 days.
9. Subjects with documented active drug or alcohol abuse within the last 12 months prior to the study.
10. Subjects with systemic collagen disorders, such as Ehlers Danlos.
11. Subjects with known allergies to hyaluronic acid, silk, lidocaine, and/or Polyethylene Glycol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multiple Abdominal Injections; Ten injections per patient: 7 of SMA-001 and 3 of control device.	Device: SMA-001; Intra-dermal injection of SMA-001 and control device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological performance	Four week histology data	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Safety of the device through Adverse Event tracking	4 weeks

Collaborators and Investigators

• Sponsor: Silk Medical Aesthetics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2019
• Primary Completion (Actual): December 23, 2019
• Study Completion (Actual): January 17, 2020

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CLN-DF-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No