Histology of SMA-001 in the Abdomen

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.

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Key information

Conditions

Abdominoplasty Medical Aesthetics

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Skincare Physicians, Inc, Chestnut Hill, Massachusetts, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

SMA-001

Device

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

Primary outcomes

Histological performance

Time frame: 4 weeks

Four week histology data

Secondary outcomes

Safety

Time frame: 4 weeks

Safety of the device through Adverse Event tracking

Sponsors and collaborators

Lead sponsor

Silk Medical Aesthetics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2020
First posted: Sep 11, 2019
Registry last updated: Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed