An interventional study of DENSITY sequential monopolar and bipolar radiofrequency device in Skin Laxity, sponsored by Cutis Medical Laser Clinics Pte Ltd. Completed at 1 site in Singapore. Open to female participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Cutis Medical Laser Clinics Pte Ltd · Not applicable, Interventional, and Treatment
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:
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:
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.
Cutis Medical Laser Clinics Pte Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: DENSITY sequential monopolar and bipolar radiofrequency device
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.
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.
Time frame: 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.
Time frame: Baseline, Day 30, and Day 90
Plan to share: 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.
Ran from Jan 2026 to primary completion in Jun 2026, 5 months.
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This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Cutis Laxa
Cutis Medical Laser Clinics Pte Ltd