Status:
UNKNOWN
Secret Micro-Needle Fractional RF System® for the Treatment of Facial Wrinkles
Lead Sponsor:
Goldman, Butterwick, Fitzpatrick and Groff
Collaborating Sponsors:
Ilooda Co., Ltd.
Conditions:
Aging
Wrinkle
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
To assess the safety, efficacy and patient satisfaction associated with the treatment of facial wrinkles using the Secret Micro-Needle Fractional RF System® (Ilooda Co., Ltd., Suwon, South Korea).
Detailed Description
Subjects satisfying all inclusion and exclusion criteria will be enrolled in this trial. After baseline evaluation, all subjects will undergo a series of 3 facial treatments with the Secret Micro-Need...
Eligibility Criteria
Inclusion
- Males or females in good general health who are greater than 22 years of age.
- Subjects may be of Fitzpatrick Skin Types I through VI.
- Subjects must desire improvement of facial skin texture and wrinkling.
- Subjects must have at least a score of 2 on the Fitzpatrick Wrinkle Scale evaluating the forehead, cheeks, and periorbital areas and Modified Fitzpatrick Wrinkle Scale evaluating the nasolabial folds (Appendix A1 and A2).
- Subjects must be willing to provide written informed consent, HIPAA authorization, and photographic release.
- Subjects must be willing to follow study instructions and complete all required visits.
- Negative urine pregnancy test results at the time of study entry (if applicable).
- The subject is healthy as judged by medical history and investigator's assessment of current health
- Female subjects will be either of non-childbearing potential defined as:
- 1\. Having no uterus. 2. No menses for at least 12 months. Or; (WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as:
- Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device (systemic birth control must have been started 30 days or more prior to enrolling)
- Intrauterine coil
- Bilateral tubal ligation
- Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
- Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active).
- Vasectomized partner (Must agree to use barrier method described above (4) if becomes sexually active with non-vasectomized).
Exclusion
- A subject who has undergone treatment with any non-ablative laser, including IPL, within the last 3 months and any ablative laser within the last 6 months.
- A subject who has undergone any microneedling treatment within the last 3 months
- A subject with a history of previous fat transfer, injectable calcium hydroxylapatite or poly-l-lactic acid to the study area within the past 6 months.
- A subject with a history of injection of hyaluronic acid dermal fillers in the study area within the past six months.
- Retinoid, hydroquinone, microdermabrasion, or chemical peel treatments to the face within one month prior to study participation or during the study.
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research studies.
- Presence of an active systemic or local skin disease that may affect wound healing.
- Presence of scarring, sunburn, tattoos, open wounds or other skin condition in area to be treated that would interfere with the assessments of this study.
- Individuals who have current skin cancers or suspicious lesions in the treatment area per Investigator.
- Individuals who are nursing, pregnant, or planning to become pregnant during the study.
- Patients who have a history with keloid formation or hypertrophic scarring.
- Inability to understand the protocol or to give informed consent.
- Subjects with deep dermal scarring or thick sebaceous skin of the treatment area.
- History of impaired immune system, including but not limited to HIV, current malignancy.
- History of chronic drug or alcohol abuse.
- Current smoker or history of smoking in the last one year.
- Subjects with known bleeding disorder or is receiving medication that will likely increase the risk of bleeding as the result of injection per investigator discretion.
- Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
- Subjects who anticipate the need for surgery or overnight hospitalization during the study.
- Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
- History of using the following prescription medications:
- Current use of psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
- Immunosuppressive medications.
- Subjects with implantable cardiac devices, such as pacemakers or implantable cardioverter-defibrillators.
Key Trial Info
Start Date :
February 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03426098
Start Date
February 10 2018
End Date
June 30 2019
Last Update
May 10 2019
Active Locations (1)
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1
West Dermatology Research Center
San Diego, California, United States, 92121