Skin LaxityNCT07919990
Effectiveness of Sequential Monopolar and Bipolar Radiofrequency Device for Facial Rejuvenation in Female Participants
A study testing DENSITY sequential monopolar and bipolar radiofrequency device in people with Skin Laxity, run by Cutis Medical Laser Clinics Pte Ltd at 1 site in Singapore.
Trial summary
The purpose of this study is to find out whether a single treatment with the DENSITY radiofrequency device improves facial skin laxity (sagging), skin texture, and pore appearance in adult women, and whether the treatment is safe and well tolerated. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Skin Laxity
- What is being tested?
- DENSITY sequential monopolar and bipolar radiofrequency device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jan 2026to 30 Sep 2026
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female, aged 25 to 60 years (both ages inclusive)
- Fitzpatrick skin type I to III
- Skin laxity Grade 1 or 2 as evaluated by the Skin Laxity Scale
- Agrees to maintain existing skincare routine throughout the study
- Able to read, speak, write, and understand the informed consent form
- Willing to have standardized clinical photographs of the treatment areas taken at all study visits
- Willing to comply with the protocol and attend all follow-up visits
- Willing to give voluntary written informed consent and photography release
Who cannot join
- Active skin infections, open wounds, dermatitis, eczema, hypertrophic scarring, keloids, or connective tissue disorders (self-declared)
- Bleeding or clotting disorders (self-declared)
- Surgical or non-surgical procedures, including skin-tightening procedures, in the treatment area within the last 6 months
- Any implant or device near the treatment area
- Current medication that, in the investigator's opinion, may influence interpretation of the data
- Clinically significant systemic or facial cutaneous disease, chronic illness, or major surgery within the last year
Show all 11Show fewer
- Participation in a similar clinical study within the 4 weeks before this study
- Pregnant or nursing (self-declared)
- Known history or present condition of allergic response to skincare or cosmetic procedures
- Uncontrolled medical illness, including diabetes mellitus, hypertension, liver disease, history of alcoholism, HIV, hepatitis, or other serious medical illness
- Employee of the sponsor or the contract research organization
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to find out whether a single treatment with the DENSITY radiofrequency device improves facial skin laxity (sagging), skin texture, and pore appearance in adult women, and whether the treatment is safe and well tolerated.
The DENSITY device delivers radiofrequency energy to the skin in two modes, one after the other: monopolar mode, which heats deeper layers of the skin, and bipolar mode, which heats more superficial layers. Heating the skin in this controlled way is intended to stimulate the body to produce new collagen, which may firm and smooth the skin over time.
Read more
Women aged 25 to 60 with mild to moderate facial skin laxity receive one treatment session to the face and neck at the first visit. They return for follow-up visits about 30 days and 90 days after treatment. At each visit, researchers take standardized 3D facial images, grade skin laxity and overall aesthetic improvement, and ask participants to complete questionnaires about how satisfied they are with their face and skin. Side effects such as redness, swelling, or discomfort are recorded throughout the study.
The main questions this study aims to answer are:
- Does one DENSITY treatment improve skin texture, pore appearance, and facial contour, as measured by 3D imaging?
- Do participants report greater satisfaction with their facial appearance and skin after treatment?
- Is the treatment safe and well tolerated?
Read the detailed description
Background and rationale Facial aging involves changes across several skin layers, including loss and disorganization of collagen and elastin, thinning of the dermis, and changes in deeper soft tissue. These changes appear as skin laxity, wrinkles, enlarged pores, and uneven texture. Radiofrequency (RF) devices deliver controlled thermal energy to the dermis, causing immediate collagen contraction followed by new collagen formation and tissue remodeling. Conventional RF systems typically use a single mode and treat a single tissue depth, which may not address changes occurring in both superficial and deeper layers at the same time.
Monopolar RF produces broader, deeper volumetric heating, while bipolar RF produces more localized heating in superficial tissue. Delivering both modes sequentially in one session may stimulate remodeling across multiple tissue depths. Prospective clinical evidence for this sequential approach is limited, and few RF studies combine quantitative 3D imaging with validated patient-reported outcome measures.
Study device and procedure The study device is the DENSITY RF system (Jeisys Medical Inc., Seoul, South Korea), operating at 6.78 MHz with sequential monopolar and bipolar delivery using Classic-F and High-F tips. A neutral grounding electrode is used during monopolar delivery. Each participant receives a single treatment session to the face and neck, administered by trained clinic personnel at an energy setting of approximately 3.0 to 3.5 over two passes (approximately 300 shots). The clinical endpoint is uniform mild erythema with a comfortable warming sensation. Topical anesthetic is applied where needed, and participants are observed for 15 to 30 minutes after treatment.
Study design and visit schedule
This is a prospective, single-center, single-arm, baseline-controlled pilot study conducted at Cutis Medical Laser Clinics, Singapore. Each participant takes part for approximately 3 months:
- Visit 1 (Day 1): screening, baseline assessments, treatment, and immediate post-treatment tolerability assessment
- Visit 2 (Day 30 +/- 5 days): follow-up assessments
- Visit 3 (Day 90 +/- 5 days): final follow-up assessments
Assessments include standardized 3D facial imaging (AURA 3D Imaging System), FACE-Q patient-reported outcome scales, investigator-assessed skin laxity grading, investigator- and participant-rated Global Aesthetic Improvement Scale (GAIS), local skin tolerability, and adverse event monitoring. Participants are asked to maintain their usual skincare routine and avoid other aesthetic treatments or new topical products during the study.
Statistical considerations As a pilot study, analyses are primarily descriptive. Changes from baseline are evaluated using paired t-tests or Wilcoxon signed-rank tests as appropriate, with two-sided significance set at p<0.05.
Ethics and conduct The study is conducted in accordance with ICH-GCP, ISO 14155:2020, the Declaration of Helsinki, and the Singapore Human Biomedical Research Act. The protocol was approved by the Parkway Independent Ethics Committee (PIEC reference 2025-047). Written informed consent is obtained from all participants before any study procedure.
- Conditions
- Skin Laxity
- Being tested
- DENSITY sequential monopolar and bipolar radiofrequency device
- Keywords
- Radiofrequency Monopolar radiofrequency Bipolar radiofrequency
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DENSITY sequential monopolar and bipolar radiofrequency deviceDevice
Single treatment session to the face and neck using the DENSITY radiofrequency system (Jeisys Medical Inc.), operating at 6.78 MHz and delivering monopolar and bipolar radiofrequency energy sequentially with Classic-F and High-F tips. Monopolar mode targets deeper tissue with a neutral grounding electrode in place; bipolar mode targets more superficial dermis. Energy setting approximately 3.0 to 3.5, two passes, approximately 300 shots, with a treatment endpoint of uniform mild erythema and a comfortable warming sensation. Topical anesthetic applied where required.
| Study group | Role | What they receive |
|---|---|---|
| DENSITY RF treatment | Experimental | Female participants aged 25 to 60 with facial skin laxity receive a single sequential monopolar and bipolar radiofrequency treatment to the face and neck on Day 1, with follow-up assessments at Day 30 and Day 90. Receives: Device: DENSITY sequential monopolar and bipolar radiofrequency device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in facial skin texture measured by AURA 3D imaging
Facial skin texture assessed from standardized three-dimensional facial images captured with the AURA 3D Imaging System (Hexagon Aura Reality AG) under standardized lighting and positioning.
Measured: Baseline, Day 30, and Day 90
Change from baseline in facial pore appearance measured by AURA 3D imaging
Facial pore size and appearance assessed from standardized three-dimensional facial images captured with the AURA 3D Imaging System under standardized lighting and positioning.
Measured: Baseline, Day 30, and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2026
- Study completion30 Sep 2026
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutis Medical Laser Clinics Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919990
- Sponsor's protocol ID
- PIEC/2025/047
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The informed consent approved by the Parkway Independent Ethics Committee did not include consent for sharing individual-level data with third parties, the dataset includes identifiable facial photographs and 3D images, and data ownership is governed by the clinical trial agreement with the sponsor. Aggregate results will be reported in the peer-reviewed publication.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sequential Monopolar and Bipolar Radiofrequency Device for Facial Rejuvenation in Female Participants
- ClinicalTrials.gov ID
- NCT07919990
- Acronym / sponsor ID
- PIEC/2025/047
- Conditions
- Skin Laxity
- Keywords
- Radiofrequency Monopolar radiofrequency Bipolar radiofrequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Cutis Medical Laser Clinics Pte LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 5 Nov 2026 (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.
The purpose of this study is to find out whether a single treatment with the DENSITY radiofrequency device improves facial skin laxity (sagging), skin texture, and pore appearance in adult women, and whether the treatment is safe and well tolerated.
The DENSITY device delivers radiofrequency energy to the skin in two modes, one after the other: monopolar mode, which heats deeper layers of the skin, and bipolar mode, which heats more superficial layers. Heating the skin in this controlled way is intended to stimulate the body to produce new collagen, which may firm and smooth the skin over time.
Women aged 25 to 60 with mild to moderate facial skin laxity receive one treatment session to the face and neck at the first visit. They return for follow-up visits about 30 days and 90 days after treatment. At each visit, researchers take standardized 3D facial images, grade skin laxity and overall aesthetic improvement, and ask participants to complete questionnaires about how satisfied they are with their face and skin. Side effects such as redness, swelling, or discomfort are recorded throughout the study.
The main questions this study aims to answer are:
- Does one DENSITY treatment improve skin texture, pore appearance, and facial contour, as measured by 3D imaging?
- Do participants report greater satisfaction with their facial appearance and skin after treatment?
- Is the treatment safe and well tolerated?
Detailed description
Background and rationale Facial aging involves changes across several skin layers, including loss and disorganization of collagen and elastin, thinning of the dermis, and changes in deeper soft tissue. These changes appear as skin laxity, wrinkles, enlarged pores, and uneven texture. Radiofrequency (RF) devices deliver controlled thermal energy to the dermis, causing immediate collagen contraction followed by new collagen formation and tissue remodeling. Conventional RF systems typically use a single mode and treat a single tissue depth, which may not address changes occurring in both superficial and deeper layers at the same time.
Monopolar RF produces broader, deeper volumetric heating, while bipolar RF produces more localized heating in superficial tissue. Delivering both modes sequentially in one session may stimulate remodeling across multiple tissue depths. Prospective clinical evidence for this sequential approach is limited, and few RF studies combine quantitative 3D imaging with validated patient-reported outcome measures.
Study device and procedure The study device is the DENSITY RF system (Jeisys Medical Inc., Seoul, South Korea), operating at 6.78 MHz with sequential monopolar and bipolar delivery using Classic-F and High-F tips. A neutral grounding electrode is used during monopolar delivery. Each participant receives a single treatment session to the face and neck, administered by trained clinic personnel at an energy setting of approximately 3.0 to 3.5 over two passes (approximately 300 shots). The clinical endpoint is uniform mild erythema with a comfortable warming sensation. Topical anesthetic is applied where needed, and participants are observed for 15 to 30 minutes after treatment.
Study design and visit schedule
This is a prospective, single-center, single-arm, baseline-controlled pilot study conducted at Cutis Medical Laser Clinics, Singapore. Each participant takes part for approximately 3 months:
- Visit 1 (Day 1): screening, baseline assessments, treatment, and immediate post-treatment tolerability assessment
- Visit 2 (Day 30 +/- 5 days): follow-up assessments
- Visit 3 (Day 90 +/- 5 days): final follow-up assessments
Assessments include standardized 3D facial imaging (AURA 3D Imaging System), FACE-Q patient-reported outcome scales, investigator-assessed skin laxity grading, investigator- and participant-rated Global Aesthetic Improvement Scale (GAIS), local skin tolerability, and adverse event monitoring. Participants are asked to maintain their usual skincare routine and avoid other aesthetic treatments or new topical products during the study.
Statistical considerations As a pilot study, analyses are primarily descriptive. Changes from baseline are evaluated using paired t-tests or Wilcoxon signed-rank tests as appropriate, with two-sided significance set at p<0.05.
Ethics and conduct The study is conducted in accordance with ICH-GCP, ISO 14155:2020, the Declaration of Helsinki, and the Singapore Human Biomedical Research Act. The protocol was approved by the Parkway Independent Ethics Committee (PIEC reference 2025-047). Written informed consent is obtained from all participants before any study procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DENSITY RF treatment | Experimental | Device: DENSITY sequential monopolar and bipolar radiofrequency deviceFemale participants aged 25 to 60 with facial skin laxity receive a single sequential monopolar and bipolar radiofrequency treatment to the face and neck on Day 1, with follow-up assessments at Day 30 and Day 90. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female, aged 25 to 60 years (both ages inclusive)
- Fitzpatrick skin type I to III
- Skin laxity Grade 1 or 2 as evaluated by the Skin Laxity Scale
- Agrees to maintain existing skincare routine throughout the study
- Able to read, speak, write, and understand the informed consent form
Key exclusion criteria (11 listed)
- Active skin infections, open wounds, dermatitis, eczema, hypertrophic scarring, keloids, or connective tissue disorders (self-declared)
- Bleeding or clotting disorders (self-declared)
- Surgical or non-surgical procedures, including skin-tightening procedures, in the treatment area within the last 6 months
- Any implant or device near the treatment area
- Current medication that, in the investigator's opinion, may influence interpretation of the data
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 |
|---|---|---|
| DENSITY sequential monopolar and bipolar radiofrequency deviceSingle treatment session to the face and neck using the DENSITY radiofrequency system (Jeisys Medical Inc.), operating at 6.78 MHz and delivering monopolar and bipolar radiofrequency energy sequentially with Classic-F and High-F tips. Monopolar mode targets deeper tissue with a neutral grounding electrode in place; bipolar mode targets more superficial dermis. Energy setting approximately 3.0 to 3.5, two passes, approximately 300 shots, with a treatment endpoint of uniform mild erythema and a comfortable warming sensation. Topical anesthetic applied where required. | Device | DENSITY RF treatment |
Primary outcome
Change from baseline in facial skin texture measured by AURA 3D imaging
Time frame: Baseline, Day 30, and Day 90
Facial skin texture assessed from standardized three-dimensional facial images captured with the AURA 3D Imaging System (Hexagon Aura Reality AG) under standardized lighting and positioning.
Change from baseline in facial pore appearance measured by AURA 3D imaging
Time frame: Baseline, Day 30, and Day 90
Facial pore size and appearance assessed from standardized three-dimensional facial images captured with the AURA 3D Imaging System under standardized lighting and positioning.
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 5 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The informed consent approved by the Parkway Independent Ethics Committee did not include consent for sharing individual-level data with third parties, the dataset includes identifiable facial photographs and 3D images, and data ownership is governed by the clinical trial agreement with the sponsor. Aggregate results will be reported in the peer-reviewed publication.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DENSITY sequential monopolar and bipolar radiofrequency device in people with Skin Laxity, run by Cutis Medical Laser Clinics Pte Ltd at 1 site in Singapore.
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 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 5 Nov 2026. 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 Singapore. 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?
Change from baseline in facial skin texture measured by AURA 3D imaging (time frame: Baseline, Day 30, and Day 90). 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 5 Nov 2026.