AbdominoplastyNCT04085822
Histology of SMA-001 in the Abdomen
A study testing SMA-001 in people with Abdominoplasty and Medical Aesthetics, run by Silk Medical Aesthetics, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abdominoplasty, Medical Aesthetics
- What is being tested?
- SMA-001
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Aug 2019to 17 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Gryskiewicz Twin Cities Cosmetic Surgery
Burnsville, Minnesota, 55337
Skincare Physicians, Inc
Chestnut Hill, Massachusetts, 02467
Jewell Plastic Surgery
Eugene, Oregon, 97401
About this study
Official title: A Histologic Study of Silk Medical Aesthetics Device in the Abdomen of Patients Undergoing Abdominoplasty
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
- Being tested
- SMA-001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMA-001Device
Intra-dermal injection of SMA-001 and control device.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Abdominal Injections | Experimental | Ten injections per patient: 7 of SMA-001 and 3 of control device. Receives: Device: SMA-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological performance
Four week histology data
Measured: 4 weeks
Secondary outcomes (1)
Safety
Safety of the device through Adverse Event tracking
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start29 Aug 2019
- Primary completion23 Dec 2019
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbdominoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silk Medical Aesthetics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085822
- Sponsor's protocol ID
- CLN-DF-001
- Status last verified
- Mar 2020
- First submitted
- 9 Sep 2019
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Histologic Study of Silk Medical Aesthetics Device in the Abdomen of Patients Undergoing Abdominoplasty
- ClinicalTrials.gov ID
- NCT04085822
- Acronym / sponsor ID
- CLN-DF-001
- Conditions
- Abdominoplasty, Medical Aesthetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Silk Medical Aesthetics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Abdominal Injections | Experimental | Device: SMA-001Ten injections per patient: 7 of SMA-001 and 3 of control device. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMA-001Intra-dermal injection of SMA-001 and control device. | Device | Multiple Abdominal Injections |
Primary outcome
Histological performance
Time frame: 4 weeks
Four week histology data
1 secondary outcome
Safety
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMA-001 in people with Abdominoplasty and Medical Aesthetics, run by Silk Medical Aesthetics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological performance (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.