Evaluation of the Potenza System for treating skin conditions
Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions
NA · Cynosure, Inc. · NCT05847530
This study is testing a new skin treatment using a special device to see if it can help improve wrinkles, scars, stretch marks, and other skin issues.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cynosure, Inc. (industry) |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT05847530 on ClinicalTrials.gov |
What this trial studies
This pilot study explores the effectiveness of the Potenza microneedle fractional radiofrequency device, potentially in combination with the Icon intense pulsed light device, for treating various cosmetic dermatologic conditions. The study aims to assess its impact on issues such as wrinkles, scars, stretch marks, pigmentation, and skin laxity. Participants will be monitored for their response to the treatment over a specified follow-up period.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 and older with specific dermatologic conditions like wrinkles, scars, or skin laxity.
Not a fit: Patients with active skin diseases or those who are pregnant or planning to become pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the appearance of various skin conditions, enhancing patients' quality of life.
How similar studies have performed: While this approach is innovative, similar studies using microneedling and radiofrequency have shown promising results in treating skin conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Diego, California
- Scripps Clinic — San Diego, California, United States (RECRUITING)
Study contacts
- Study coordinator: Jamie Trimper
- Email: jamie.trimper@cynosure.com
- Phone: (978) 256-4200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Wrinkles, Scars, Stretch Marks, Pigmentation, Skin Laxity