Skin LaxityNCT03407313

CONFORM: Rotational Fractional Resection for Submental Contouring

A study testing Rotational fractional resection (1.5mm diameter device) in people with Skin Laxity and Lipodystrophy, run by Recros Medica, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. RFR is used to remove loose skin and fat. Read more about this study

Who is it for?: Ages 30 years and olderHealthy volunteers can take part
Conditions the study is for: Skin Laxity, Lipodystrophy
What is being tested?: Rotational fractional resection (1.5mm diameter device)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 6 sitesUnited States
Study dates: 8 Jan 2018to 23 Apr 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 30 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy male or female, at least 30 years old
Moderate submental (neck) fat
Mild to moderate submental (neck) skin laxity (loose skin)
Willing and able to provide informed consent
Willing and able to comply with all protocol requirements
Willing to limit direct sun exposure and use sunscreen for duration of the study
Agree to maintain weight for duration of the study
Willing to have photographs taken that could identify the participant

Who cannot join

Previous intervention to treat submental fat or skin laxity
Use of aspirin, ibuprofen, naproxen, or Vitamin E within 14 days of the procedure
Sensitivity to local anesthesia
Severe acne, cystic acne or acne scars on neck
Trauma of chin or neck area
Skin infection or rash on neck

Show all 13Show fewer

Psoriasis, eczema, rosacea, or vitiligo
History of scarring
History or current symptoms of dysphagia
Chronic or persistent coughing
Body mass index (BMI) > 30
Clinically significant bleeding disorder
Anemia, kidney disease, or liver disease

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Aesthetx
Campbell, California, 95008
DeNova Research
Chicago, Illinois, 60611
Sundaram Dermatology, Cosmetic & Laser Surgery Center
Fairfax, Virginia, 22031
Miami Dermatology & Laser Institute
Miami, Florida, 33173
Steve Yoelin, MD Medical Associates, Inc.
Newport Beach, California, 92663
Roseville Facial Plastic Surgery
Roseville, California, 95661

Other trials in United States

About this study

Official title: The CONFORM Study: A Multi-center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring

This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. RFR is used to remove loose skin and fat.

Read the detailed description

This is a prospective, multi-center, single-arm (non-randomized), interventional cohort, non-significant risk (NSR) study designed to investigate the efficacy and safety of Rotational Fractional Resection (skin resection and focal lipectomy) in patients with mild to moderate submental fat and mild to moderate submental skin laxity. The total duration of study participation for each subject is approximately up to 7 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 6 months after the procedure. Eligible subjects will complete a total of 8 study visits: screening, procedure, and follow-up visits at 1, 7, 14, 30, 90 and 180 days post-procedure.

Conditions: Skin Laxity, Lipodystrophy
Being tested: Rotational fractional resection (1.5mm diameter device)
Keywords: Submental fullness, Submental fat, Loose skin
Medical subject headings: Cutis Laxa, Lipodystrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rotational fractional resection (1.5mm diameter device)Device
Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)

Study groups in NCT03407313
Study group	Role	What they receive
Rotational fractional resection (1.5mm diameter device)	Experimental	Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) Receives: Device: Rotational fractional resection (1.5mm diameter device)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2
This endpoint is the difference in the measurement of submental skin area (mm^2) between Baseline and 90 days. A reduction of ≥ 20 mm^2 denotes improvement.
Measured: Baseline and 90 days post treatment

Secondary outcomes (2)

Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline
Subjects rated their satisfaction of the appearance of their neck and jawline on a Subject Satisfaction Questionnaire. Results reflect subjects who were satisfied ("somewhat satisfied", "satisfied", or "very satisfied").
Measured: 90 days after treatment
Number of Participants With Post-treatment Images Correctly Identified
Correct identification of post-treatment images by three blinded independent reviewers in more than 50% of subjects
Measured: Pre-treatment and 90 days after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jan 201823 Apr 2019

First posted23 Jan 2018
Study start8 Jan 2018
Primary completion28 Dec 2018
Study completion23 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Skin LaxityStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03407313
Sponsor's protocol ID: CLP-0002
Status last verified: Jan 2021
First submitted: 16 Jan 2018
Last updated: 3 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The CONFORM Study: A Multi-center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring
ClinicalTrials.gov ID: NCT03407313
Acronym / sponsor ID: CLP-0002
Conditions: Skin Laxity, Lipodystrophy
Keywords: Submental fullness, Submental fat, Loose skin
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Recros Medica, Inc.Industry (pharma, biotech, devices)
Study start: 8 Jan 2018 (actual)
Primary completion: 28 Dec 2018 (actual)
Study completion: 23 Apr 2019 (actual)
First posted: 23 Jan 2018 (actual)
Results: Posted 3 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. RFR is used to remove loose skin and fat.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Rotational fractional resection (1.5mm diameter device)	Experimental	Device: Rotational fractional resection (1.5mm diameter device)Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Healthy male or female, at least 30 years old
Moderate submental (neck) fat
Mild to moderate submental (neck) skin laxity (loose skin)
Willing and able to provide informed consent
Willing and able to comply with all protocol requirements

Key exclusion criteria (13 listed)

Previous intervention to treat submental fat or skin laxity
Use of aspirin, ibuprofen, naproxen, or Vitamin E within 14 days of the procedure
Sensitivity to local anesthesia
Severe acne, cystic acne or acne scars on neck
Trauma of chin or neck area

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
Rotational fractional resection (1.5mm diameter device)Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)	Device	Rotational fractional resection (1.5mm diameter device)

Primary outcome

Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2
Time frame: Baseline and 90 days post treatment
This endpoint is the difference in the measurement of submental skin area (mm^2) between Baseline and 90 days. A reduction of ≥ 20 mm^2 denotes improvement.

2 secondary outcomes

Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline
Time frame: 90 days after treatment
Number of Participants With Post-treatment Images Correctly Identified
Time frame: Pre-treatment and 90 days after treatment

Results and safety

Results posted to the registry on 3 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rotational Fractional Resection (1.5mm Diameter Device)	68	66

Primary outcome: Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2

Time frame: Baseline and 90 days post treatment. Count of participants. Unit: Participants

Measure	Rotational Fractional Resection (1.5mm Diameter Device) n = 68
Value	49

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 180 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rotational Fractional Resection (1.5mm Diameter Device)	0 of 68 (0%)	45 of 68 (66.2%)	0 of 68

Limitations and caveats (from the sponsor): This study evaluated 1.5mm diameter skin resections, our first-generation prototype, in the submentum area.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Recruiting
VISION Study: Visualization-Guided SMAS Treatment to Optimize Nonsurgical Lifting
Facial Skin Laxity
Not yet recruiting
Enhancing the Durability of Thread-Assisted Brow Suspension Through Upper Blepharoplasty-Assisted Ligament Release
Brow Ptosis, Dermatochalasis
Not yet recruitingPhase 4
Randomized Trial of Combination Treatment With Sofwave and Sculptra
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Recruiting
Pre-marketing Trial to Assess Safety and Efficacy of 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'
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Active, not recruiting
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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.

Edward W Knowlton, MD study director

Recros Medica, Inc.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Rotational fractional resection (1.5mm diameter device) in people with Skin Laxity and Lipodystrophy, run by Recros Medica, Inc. at 6 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 8 inclusion and 13 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 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

Yes. Results are posted in the registry (first posted 3 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2 (time frame: Baseline and 90 days post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03407313.

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 3 Feb 2021.