Status:
COMPLETED
Histology of SMA-001 in the Abdomen
Lead Sponsor:
Silk Medical Aesthetics, Inc.
Conditions:
Abdominoplasty
Medical Aesthetics
Eligibility:
FEMALE
25-65 years
Phase:
NA
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 hist...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04085822
Start Date
August 29 2019
End Date
January 17 2020
Last Update
March 19 2020
Active Locations (3)
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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