Skin Laxity Clinical Trial
Official title:
Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions
NCT number | NCT05847530 |
Other study ID # | MD-PL01-2022 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2024 |
Est. completion date | January 2025 |
The primary objective of this pilot study is exploratory investigation evaluating the Potenza microneedle fractional radiofrequency (RF) device and may be used in combination with the Icon intense pulsed light (IPL) device.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | January 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Healthy male or female 18 years of age or older. - Presence of unwanted dermatologic condition suitable for treatment such as facial and/or neck wrinkles, skin laxity of face, neck or body, scars, acne scars or striae, or Vascular and/or pigment dyschromia - Ability to read, understand, and sign the Informed Consent Form - Understands and accepts the obligation not to undergo any other procedures in the areas to be treated and/or weight loss through the follow-up period. - Willing and able to comply with all study participation requirements including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study Exclusion Criteria: - Is pregnant or of childbearing potential and not using (or willing to use) medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study. - Presence of an active systemic or local skin disease or condition that may affect wound healing or interfere with participation. - History of keloids or poor wound healing - Taking medication which is known to increase sensitivity to sunlight - Has a seizure disorders triggered by light - Cancer, malignant disease, skin pathology, condition or allergic reactions that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments - History of collagen, vascular or immunosuppressive or deficiency disorders - History of coagulative disorder or use of anticoagulant drugs within 2 weeks of study treatment - Use of steroids within 2 weeks of study treatments - Use of Accutane (isotretinoin) in the past 12 months - Previous surgical or cosmetic procedure to the target area in the last 6 to 12 months that could interfere with the treatment procedure and affect treatment outcome - Has an implanted pacemaker or defibrillator, metal pins or prosthetic joints - Allergic reaction to gold metal - Receiving or have received gold therapy - Photo-sensitive skin - Psycho-neurotic condition including alcohol or drug abuse - Unwilling or unable to adhere to all study requirements for treatment and follow-up - Has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation. |
Country | Name | City | State |
---|---|---|---|
United States | Scripps Clinic | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Cynosure, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Grading of Skin Aging and Photodamage | At the 90 day follow up, subjects will be graded on a scale of 0-4 (0 being none and 4 being severe) for the presence of skin aging and photodamage. The # of subjects with improvement will be reported. | 90 days post last treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06140628 -
A 28-day Clinical Study on Facial Skin Rejuvenation
|
N/A | |
Completed |
NCT01971736 -
Efficacy of Long Pulsed 1064nm Laser for Facial Skin Tightening
|
N/A | |
Completed |
NCT01713985 -
Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck
|
N/A | |
Completed |
NCT01713998 -
Treatment of the Face and Neck With Lower Ulthera System Energy Settings
|
N/A | |
Completed |
NCT01708252 -
Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment
|
N/A | |
Completed |
NCT01708382 -
Feasibility Study: Lifting and Tightening of the Elbows
|
N/A | |
Completed |
NCT04296201 -
Evaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology
|
N/A | |
Completed |
NCT06000839 -
A Safety and Effectiveness Study of CELLBOOSTER® Lift (Stabilized Booster Complex Using CHAC Technology)
|
N/A | |
Completed |
NCT06366503 -
Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation
|
N/A | |
Completed |
NCT05929625 -
Radiofrequency and Ultrasound for Improvement of Skin Laxity and Wrinkles: Efficacy and Safety Evaluation
|
N/A | |
Terminated |
NCT01713569 -
Feasibility Study: Histological Characterization After Treatment With the Ulthera® System
|
N/A | |
Completed |
NCT01519934 -
A Retrospective Study to Evaluate the Effectiveness of the Ulthera System
|
N/A | |
Completed |
NCT05605691 -
Post-Market Lower Eyelid Treatment With Renuvion in Greece
|
N/A | |
Completed |
NCT04477187 -
Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling
|
N/A | |
Completed |
NCT05590364 -
Aesthetic Performance and Tolerance of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Back of the Hands
|
N/A | |
Active, not recruiting |
NCT06243744 -
Histological Evaluation of Human Skin Bx to Assess the Effects of APR Tx as an Adjunct Procedure in Facelift Surgery
|
N/A | |
Completed |
NCT04146584 -
Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
|
Phase 2 | |
Recruiting |
NCT05750901 -
Evaluation of Fractional Ablative Laser Treatment for Skin Conditions
|
N/A | |
Completed |
NCT04721600 -
Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance
|
N/A | |
Recruiting |
NCT06157567 -
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
|
N/A |