Skin LaxityNCT03853980
The INFORM Study: Rotational Fractional Resection for Submental Contouring
A study testing Focal Contouring System in people with Skin Laxity, run by Recros Medica, Inc. at 14 sites in United States.
Trial summary
Efficacy and safety of Rotational Fractional Resection (skin resection) in patients with moderate to severe submental skin laxity. 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
- What is being tested?
- Focal Contouring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 14 sitesUnited States
- Study dates
- 18 Mar 2019to 31 Oct 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 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 to severe submental laxity
- Agree to maintain weight (±5%) for the duration of the study
Who cannot join
- Greater than mild submental fat
- Previous intervention to treat submental fat or skin laxity
- Use of aspirin, ibuprofen, naproxen, or Vitamin E within 14 days of the procedure
- Severe acne, cystic acne or acne scars on neck
- Trauma of chin or neck area
- Skin infection or rash on neck
Show all 11Show fewer
- Psoriasis, hyperpigmentation, eczema, rosacea or vitiligo
- History of scarring
- Body mass index (BMI) >30
- Clinically significant bleeding disorder
- Anemia, kidney disease, or liver disease
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Bellaire Dermatology Associates
Bellaire, Texas, 77401
Aesthetx
Campbell, California, 95008
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
DeNova Research
Chicago, Illinois, 60611
Clinical Testing of Beverly Hills
Encino, California, 91436
Sundaram Dermatology, Cosmetic & Laser Surgery Center
Fairfax, Virginia, 22031
AboutSkin Research
Greenwood Village, Colorado, 80111
Westside Aesthetics
Los Angeles, California, 90025
Brian Biesman, MD
Nashville, Tennessee, 37203
Juva Skin and Laser Center
New York, New York, 10022
ATS Clinical Research
Santa Monica, California, 90404
Premier Clinical Research
Spokane, Washington, 99202
Moradi MD
Vista, California, 92083
Washington Institute of Dermatologic Laser Surgery
Washington D.C., District of Columbia, 20005
About this study
Official title: The INFORM Study: A Multi-Center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring With an Optimized Post-Procedure Treatment Plan
Efficacy and safety of Rotational Fractional Resection (skin resection) in patients with moderate to severe submental skin laxity.
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) in patients with moderate to severe submental skin laxity. The total duration of study participation for each subject is approximately up to 4 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 3 months after the procedure. Eligible subjects will complete a total of 11 study visits: screening, procedure, and follow-up visits at 1, 2-4, 7, 14, 21, 30, 45, 60, and 90 days post-procedure.
- Conditions
- Skin Laxity
- Being tested
- Focal Contouring System
- Keywords
- submental, laxity
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal Contouring SystemDevice
Single treatment of skin resection (removal of loose skin)
| Study group | Role | What they receive |
|---|---|---|
| Rotational fractional resection (RFR) | Experimental | Single treatment of skin resection (removal of loose skin) Receives: Device: Focal Contouring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Skin Laxity
Comparison of the submentum before and after procedure using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)
Measured: Pre-treatment and 90 days after treatment
Subject Satisfaction: Subject Satisfaction Questionnaire
Comparison of Subject satisfaction of the procedure as assessed using the Subject Satisfaction Questionnaire
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.
- First posted26 Feb 2019
- Study start18 Mar 2019
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recros Medica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robin McIntosh, Study director, Recros Medica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853980
- Sponsor's protocol ID
- CLP-0006
- Status last verified
- Mar 2020
- First submitted
- 21 Feb 2019
- Last updated
- 6 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 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The INFORM Study: A Multi-Center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring With an Optimized Post-Procedure Treatment Plan
- ClinicalTrials.gov ID
- NCT03853980
- Acronym / sponsor ID
- CLP-0006
- Conditions
- Skin Laxity
- Keywords
- submental, laxity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Recros Medica, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 26 Feb 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.
Efficacy and safety of Rotational Fractional Resection (skin resection) in patients with moderate to severe submental skin laxity.
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) in patients with moderate to severe submental skin laxity. The total duration of study participation for each subject is approximately up to 4 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 3 months after the procedure. Eligible subjects will complete a total of 11 study visits: screening, procedure, and follow-up visits at 1, 2-4, 7, 14, 21, 30, 45, 60, and 90 days post-procedure.
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 (RFR) | Experimental | Device: Focal Contouring SystemSingle treatment of skin resection (removal of loose skin) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male or female
- At least 30 years old
- Moderate to severe submental laxity
- Agree to maintain weight (±5%) for the duration of the study
Key exclusion criteria (11 listed)
- Greater than mild submental fat
- Previous intervention to treat submental fat or skin laxity
- Use of aspirin, ibuprofen, naproxen, or Vitamin E within 14 days of the procedure
- 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 |
|---|---|---|
| Focal Contouring SystemSingle treatment of skin resection (removal of loose skin) | Device | Rotational fractional resection (RFR) |
Primary outcome
Improved Skin Laxity
Time frame: Pre-treatment and 90 days after treatment
Comparison of the submentum before and after procedure using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)
Subject Satisfaction: Subject Satisfaction Questionnaire
Time frame: Pre-treatment and 90 days after treatment
Comparison of Subject satisfaction of the procedure as assessed using the Subject Satisfaction Questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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.
Robin McIntosh study director
Recros Medica
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal Contouring System in people with Skin Laxity, run by Recros Medica, Inc. at 14 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: status not confirmed, as of the sponsor's last update on 6 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 14 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?
Results are not available in the source record.
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?
Improved Skin Laxity (time frame: Pre-treatment and 90 days after treatment). The study lists 2 primary outcomes in all. 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 6 Mar 2020.