Histology of SMA-001 in the Abdomen

• Sponsor: Silk Medical Aesthetics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04085822
• Collaborator: (none)
• Enrollment: 13
• Locations: 3
• Arm: 1
• Actual Duration (Months): 4.6
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominoplasty; Medical Aesthetics	Device: SMA-001	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: A Histologic Study of Silk Medical Aesthetics Device in the Abdomen of Patients Undergoing Abdominoplasty
• Actual Study Start Date: Aug 29, 2019
• Actual Primary Completion Date: Dec 23, 2019
• Actual Study Completion Date: Jan 17, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Histological performance [4 weeks]

   Four week histology data

Secondary Outcome Measures

1. Safety [4 weeks]

   Safety of the device through Adverse Event tracking

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Skincare Physicians, Inc	Chestnut Hill	Massachusetts	United States	02467
2	Gryskiewicz Twin Cities Cosmetic Surgery	Burnsville	Minnesota	United States	55337
3	Jewell Plastic Surgery	Eugene	Oregon	United States	97401

Sponsors and Collaborators

• Silk Medical Aesthetics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Silk Medical Aesthetics, Inc.
• ClinicalTrials.gov Identifier: NCT04085822
• Other Study ID Numbers: CLN-DF-001
• First Posted: Sep 11, 2019
• Last Update Posted: Mar 19, 2020
• Last Verified: Mar 1, 2020

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

Study Results

No Results Posted as of Mar 19, 2020