Secret Micro-Needle Fractional RF System® for the Treatment of Facial Wrinkles

Status unconfirmed · Not applicable

Conditions studied: Aging, Wrinkle

In brief

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).

Key facts

Study ID

NCT03426098

Run by

Goldman, Butterwick, Fitzpatrick and Groff

People needed

40

Starts

2018-02-10

Expected to finish

2019-06-30

Last updated by the study team

2019-05-10

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• 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).

You may not qualify if…

• 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.

Where it is running

• West Dermatology Research Center — San Diego, California, United States

Full record on ClinicalTrials.gov

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