Skin LaxityNCT04245696
Bipolar RF Microneedling for Improved Laxity and Lift of the Submental and Neck Tissue and Effect on Elastin
A study testing Dermal Handpiece / SubQ Handpiece in people with Skin Laxity, run by Candela Corporation at 1 site in United States.
Trial summary
This study is being conducted to evaluate the safety and efficacy of bipolar fractional radiofrequency treatment via use of the Profound System to achieve lift in lax submental (beneath the chin) and neck tissue Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- Dermal Handpiece / SubQ Handpiece
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2020to 5 Aug 2021
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female adults between ages 21-70 years of age.
- Desire skin laxity lift of submental and neck regions.
- Confirmed BMI ≤ 35.
- Subjects who can read, understand, and sign the Informed Consent Form.
- Subjects willing and able to comply with all study requirements.
- Fitzpatrick skin type I-VI.
- Submental fat graded by the Investigator as ≥ 1 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS, 0=Absent (No localized submental fat evidence), 4=Extreme (Extreme submental convexity)
Who cannot join
- Active localized or systemic infections, that may alter wound healing.
- Immunocompromised subjects.
- Subjects with coagulation disorder.
- History of skin photosensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
- Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
- Excessive skin laxity on the submental and neck (Submental Skin Laxity Grade: SMSLG 4=Severe, superficial wrinkling present), or other anatomical feature for which reduction in submental fat (SMF) which may, in the judgment of the investigator, result in an aesthetically unacceptable outcome.
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- Scarring in areas to be treated.
- Tattoos in the treatment areas to be treated.
- Significant open facial wounds or lesions.
- Severe or cystic acne in treatment areas.
- Current active smoker.
- Use of Accutane (Isotretinoin) within the past 6 months.
- Use of topical retinoids within 48 hours.
- Use of prescription anticoagulants.
- Pacemaker or internal defibrillator.
- History of skin disorders resulting in abnormal wound healing (i.e. keloids, extreme dry and fragile skin).
- Subjects on current oral corticosteroid therapy or within the past 6 months
- Metal implants in the treatment area.
- In the opinion of the investigator, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
- Subjects with a history of radiation therapy to the treatment area.
- Subject has a history of allergy to lidocaine or ester-based local anesthetics.
- Subjects with significant cardiac history or rhythm disturbance who may be unable to tolerate lidocaine with epinephrine.
- Subjects with any skin pathology or condition in the treatment area that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments (e.g. psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, hyper or hypo-skin pigmentation conditions such as post inflammatory hyperpigmentation).
- Subjects who are unwilling to shave excessive hair in the treatment area that might influence or impair evaluation in the opinion of the Investigator.
- Subjects have undergone skin resurfacing or tightening treatments in the treatment area over the past year.
- Subjects have undergone dermatological treatments such as fillers and neurotoxins for the past 6 months in the treatment area.
- Subjects have undergone laser and light treatments in the treatment area over the past 3 months.
- Subjects have undergone superficial peel or microdermabrasion within 4 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Candela Institute of Excellence
Marlborough, Massachusetts, 01752
About this study
Official title: Clinical Assessment of Bipolar Radiofrequency Microneedling for Improved Laxity and Lift of the Submental and Neck Tissue
This study is being conducted to evaluate the safety and efficacy of bipolar fractional radiofrequency treatment via use of the Profound System to achieve lift in lax submental (beneath the chin) and neck tissue
Read the detailed description
A multi-center, blinded, non-randomized, non-controlled study
Up to 60 eligible participants will be enrolled at up to three (3) sites. Participants will receive one (1) treatment in the submental/neck area. Participants will complete follow-up visits for clinical evaluation at Day 14, 1 Month, 3 Month, and 6 Months after the study treatment. Standard photography will be obtained at Screening to the 6 Month follow-up, and 3D photography will be obtained at Screening, Month 3, and Month 6 visit.
- Conditions
- Skin Laxity
- Being tested
- Dermal Handpiece / SubQ Handpiece
- Keywords
- RF, Micro-needling, Submental Skin 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.
Dermal Handpiece / SubQ HandpieceDevice
Bipolar radiofrequency (RF) travels from the RF generator, through the electrodes and into the dermal layers beneath the surface of the skin. The microneedles of the Dermal and SubQ cartridges coupled with thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity.
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Experimental | Single Arm: All subjects will undergo treatment for skin laxity in the submentum with a Dermal and SubQ handpiece Receives: Device: Dermal Handpiece / SubQ Handpiece |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in submental skin laxity
Improvement in overall lifting of treated tissue in the submental/neck region via blinded evaluation of Baseline (pre-procedure) and Day 180 (post-procedure) photographs
Measured: Baseline - Day 180 (6 months post-treatment)
Occurrence, severity, and relatedness of adverse events
The number and level of severity of adverse events after device treatment. An assessment will also be made to determine if the adverse event is related to the study devices and/or procedure
Measured: Baseline - Day 180 (6 months post-treatment)
Secondary outcomes (5)
Change in submental skin laxity
Improvement in overall lifting of treated tissue in the submental/neck region via blinded evaluation of Baseline (pre-procedure) and Day 90 (post-procedure) photographs
Measured: Baseline - Day 90 (3 months post-treatment)
Surface Area Assessment to demonstrate percentage of participants having improvement in tissue lift (> 20mm2 in submental and neck skin laxity)
Change in submental and neck skin laxity via 3D photo-analysis
Measured: Baseline vs. Day 180
Subject assessment of improvement in skin laxity
Improvement in skin laxity scored by subject using a 5-point Global Aesthetic Improvement Score (1=Very Much Improved, 5=Worse)
Measured: 3 Month Follow-Up and 6 Month Follow-Up
Subject satisfaction of treatment results: Subject Satisfaction scale
Using a Subject Satisfaction scale, subjects will score satisfaction of treatment results (1=Not Satisfied, 5=Very Satisfied). Lower scores will show worse outcomes and higher scores will show better outcomes.
Measured: Day 14 - 6 Month Follow-Up
Subject assessment of pain: Numerical Pain Rating Scale
The subjects' assessment of pain will be completed using an 11-point Numerical Pain Rating Scale (0=No pain, 10=extreme pain)
Measured: Treatment Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start9 Mar 2020
- Primary completion5 Aug 2021
- Study completion5 Aug 2021
Why it stopped: Business decision, no serious AEs.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Candela Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Konika Patel Schallen, MD, Principal investigator, Candela Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245696
- Sponsor's protocol ID
- PFD19002
- Status last verified
- Aug 2021
- First submitted
- 27 Jan 2020
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Bipolar Radiofrequency Microneedling for Improved Laxity and Lift of the Submental and Neck Tissue
- ClinicalTrials.gov ID
- NCT04245696
- Acronym / sponsor ID
- PFD19002
- Conditions
- Skin Laxity
- Keywords
- RF, Micro-needling, Submental Skin Laxity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision, no serious AEs.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Candela CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 29 Jan 2020 (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.
This study is being conducted to evaluate the safety and efficacy of bipolar fractional radiofrequency treatment via use of the Profound System to achieve lift in lax submental (beneath the chin) and neck tissue
Detailed description
A multi-center, blinded, non-randomized, non-controlled study
Up to 60 eligible participants will be enrolled at up to three (3) sites. Participants will receive one (1) treatment in the submental/neck area. Participants will complete follow-up visits for clinical evaluation at Day 14, 1 Month, 3 Month, and 6 Months after the study treatment. Standard photography will be obtained at Screening to the 6 Month follow-up, and 3D photography will be obtained at Screening, Month 3, and Month 6 visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Device: Dermal Handpiece / SubQ HandpieceSingle Arm: All subjects will undergo treatment for skin laxity in the submentum with a Dermal and SubQ handpiece |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy male and female adults between ages 21-70 years of age.
- Desire skin laxity lift of submental and neck regions.
- Confirmed BMI ≤ 35.
- Subjects who can read, understand, and sign the Informed Consent Form.
- Subjects willing and able to comply with all study requirements.
Key exclusion criteria (28 listed)
- Active localized or systemic infections, that may alter wound healing.
- Immunocompromised subjects.
- Subjects with coagulation disorder.
- History of skin photosensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
- Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
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 |
|---|---|---|
| Dermal Handpiece / SubQ HandpieceBipolar radiofrequency (RF) travels from the RF generator, through the electrodes and into the dermal layers beneath the surface of the skin. The microneedles of the Dermal and SubQ cartridges coupled with thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity. | Device | Single Group |
Primary outcome
Change in submental skin laxity
Time frame: Baseline - Day 180 (6 months post-treatment)
Improvement in overall lifting of treated tissue in the submental/neck region via blinded evaluation of Baseline (pre-procedure) and Day 180 (post-procedure) photographs
Occurrence, severity, and relatedness of adverse events
Time frame: Baseline - Day 180 (6 months post-treatment)
The number and level of severity of adverse events after device treatment. An assessment will also be made to determine if the adverse event is related to the study devices and/or procedure
5 secondary outcomes
Change in submental skin laxity
Time frame: Baseline - Day 90 (3 months post-treatment)
Surface Area Assessment to demonstrate percentage of participants having improvement in tissue lift (> 20mm2 in submental and neck skin laxity)
Time frame: Baseline vs. Day 180
Subject assessment of improvement in skin laxity
Time frame: 3 Month Follow-Up and 6 Month Follow-Up
Subject satisfaction of treatment results: Subject Satisfaction scale
Time frame: Day 14 - 6 Month Follow-Up
Subject assessment of pain: Numerical Pain Rating Scale
Time frame: Treatment Visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
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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.
Konika Patel Schallen, MD principal investigator
Candela Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermal Handpiece / SubQ Handpiece in people with Skin Laxity, run by Candela Corporation at 1 site 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 7 inclusion and 28 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: withdrawn, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in submental skin laxity (time frame: Baseline - Day 180 (6 months post-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 Aug 2021.