Clinical trial NCT04085822: Histology of SMA-001 in the Abdomen
Official title: A Histologic Study of Silk Medical Aesthetics Device in the Abdomen of Patients Undergoing Abdominoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominoplasty
Medical Aesthetics
Lead sponsor: Silk Medical Aesthetics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-11
Enrollment: 13
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


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.

Primary outcomes:
measure: Histological performance
timeFrame: 4 weeks
Secondary outcomes:
measure: Safety
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Skincare Physicians, Inc
state: Massachusetts
city: Burnsville
country: United States
facility: Gryskiewicz Twin Cities Cosmetic Surgery
state: Minnesota
city: Eugene
country: United States
facility: Jewell Plastic Surgery
state: Oregon
Study officials:
References: