Histology of SMA-001 in the Abdomen

Abdominoplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085822
• Other study ID #: CLN-DF-001
• Status: Completed
• Phase: N/A
• Start date: August 29, 2019
• Est. completion date: January 17, 2020

Study information

• Verified date: March 2020
• Source: Silk Medical Aesthetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 17, 2020
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominoplasty
• Medical Aesthetics

Intervention

Device:
• SMA-001
Intra-dermal injection of SMA-001 and control device.

Locations

Country	Name	City	State
United States	Gryskiewicz Twin Cities Cosmetic Surgery	Burnsville	Minnesota
United States	Skincare Physicians, Inc	Chestnut Hill	Massachusetts
United States	Jewell Plastic Surgery	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Silk Medical Aesthetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological performance	Four week histology data	4 weeks
Secondary	Safety	Safety of the device through Adverse Event tracking	4 weeks