Histology of SMA-001 in the Abdomen

NCT04085822 | Completed FDA Device

• 1 other identifier: CLN-DF-001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Abdominoplasty; Medical Aesthetics

Outcome Measures

Primary Outcomes (1)

• Histological performance

  Four week histology data

  4 weeks

Secondary Outcomes (1)

• Safety

  4 weeks

Study Arms (1)

Multiple Abdominal Injections

EXPERIMENTAL

Ten injections per patient: 7 of SMA-001 and 3 of control device.

Device: SMA-001

Interventions

SMA-001 DEVICE

Intra-dermal injection of SMA-001 and control device.

Multiple Abdominal Injections

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Silk Medical Aesthetics, Inc.: lead

Study Sites (3)

Skincare Physicians, Inc

Chestnut Hill, Massachusetts, 02467, United States

Location

Gryskiewicz Twin Cities Cosmetic Surgery

Burnsville, Minnesota, 55337, United States

Location

Jewell Plastic Surgery

Eugene, Oregon, 97401, United States

Location

Study Design

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

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 11, 2019
• Study Start: August 29, 2019
• Primary Completion: December 23, 2019
• Study Completion: January 17, 2020
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)