Effectiveness of Sequential Monopolar and Bipolar Radiofrequency Device for Facial Rejuvenation in Female Participants
NCT07919990, Not applicable, Completed, Cutis Medical Laser Clinics Pte Ltd
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effectiveness of Sequential Monopolar and Bipolar Radiofrequency Device for Facial Rejuvenation in Female Participants | ClinicalTrials.gov |
| NCT number | NCT07919990 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 14 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Cutis Medical Laser Clinics Pte Ltd | ClinicalTrials.gov |
| Conditions | Skin Laxity | ClinicalTrials.gov |
| Interventions | DENSITY sequential monopolar and bipolar radiofrequency device | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from baseline in facial skin texture measured by AURA 3D imaging | 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. | ClinicalTrials.gov |
| Primary | Change from baseline in facial pore appearance measured by AURA 3D imaging | 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in facial contour measured by AURA 3D imaging | Baseline, Day 30, and Day 90 | Facial contour assessed from standardized three-dimensional (3D) facial images captured with the AURA 3D Imaging System (Hexagon Aura Reality AG) under standardized lighting and positioning. | ClinicalTrials.gov |
| Secondary | Change from baseline in investigator-assessed skin laxity grade | Baseline, Day 30, and Day 90 | Facial skin laxity graded by the investigator using the Skin Laxity Scale. A lower grade indicates less skin laxity. | ClinicalTrials.gov |
| Secondary | Change from baseline in FACE-Q satisfaction scores | Baseline, Day 30, and Day 90 | Participant-reported satisfaction with facial appearance and with skin, measured with FACE-Q patient-reported outcome scales. Scale scores range from 0 to 100; higher scores indicate greater satisfaction. | ClinicalTrials.gov |
| Secondary | Investigator-rated Global Aesthetic Improvement Scale (GAIS) score | Day 30 and Day 90 | Overall aesthetic improvement compared with baseline, rated by the investigator on the 5-point GAIS (very much improved, much improved, improved, no change, worse). | ClinicalTrials.gov |
| Secondary | Participant-rated Global Aesthetic Improvement Scale (GAIS) score | Day 30 and Day 90 | Overall aesthetic improvement compared with baseline, rated by the participant on the 5-point GAIS (very much improved, much improved, improved, no change, worse). | ClinicalTrials.gov |
| Secondary | Number of participants with adverse events and local skin reactions | Day 1 (immediately after treatment) through Day 90 | Safety and tolerability, assessed as the number of participants with adverse events and with local skin reactions (such as erythema, edema, or discomfort) recorded immediately after treatment and at each follow-up visit. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)