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Histology of SMA-001 in the Abdomen

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ClinicalTrials.gov Identifier: NCT04085822
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Silk Medical Aesthetics, Inc.

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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 : August 29, 2019
Estimated Primary Completion Date : January 6, 2020
Estimated Study Completion Date : February 6, 2020

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.




Primary Outcome Measures :
  1. Four week histology data [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Safety of the device through Adverse Event tracking [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085822


Contacts
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Contact: Laura Batterman 9498743487 lbatterman@boston-biomedical.com

Locations
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United States, Massachusetts
Skincare Physicians, Inc Not yet recruiting
Chestnut Hill, Massachusetts, United States, 02467
Contact: Kathleen Petrell    617-848-1638    kpetrell@skincarephysicians.net   
Principal Investigator: Brooke Sikora, MD         
United States, Minnesota
Gryskiewicz Twin Cities Cosmetic Surgery Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Pam Meyer    952-435-0177    pam@tcplasticsurgery.com   
Principal Investigator: Joe Gryskiewicz, MD         
United States, Oregon
Jewell Plastic Surgery Not yet recruiting
Eugene, Oregon, United States, 97401
Contact: Mark Jewell       info@markjewellmd.com   
Principal Investigator: Mark Jewell, MD         
Sponsors and Collaborators
Silk Medical Aesthetics, Inc.

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Responsible Party: Silk Medical Aesthetics, Inc.
ClinicalTrials.gov Identifier: NCT04085822     History of Changes
Other Study ID Numbers: CLN-DF-001
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No