Histology of SMA-001 in the Abdomen

NCT ID: NCT04085822

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-29
• Study Completion Date: 2020-01-17

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Multiple Abdominal Injections

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

Group Type: EXPERIMENTAL

SMA-001

Intervention Type: DEVICE

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

Interventions

SMA-001

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Silk Medical Aesthetics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Skincare Physicians, Inc

Chestnut Hill, Massachusetts, United States

Gryskiewicz Twin Cities Cosmetic Surgery

Burnsville, Minnesota, United States

Jewell Plastic Surgery

Eugene, Oregon, United States

Countries

United States

Other Identifiers

CLN-DF-001

Identifier Type: -

Identifier Source: org_study_id