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

NCT03426098 | Unknown FDA Device

• 1 other identifier: 0922-1228
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Aging; Wrinkle

Outcome Measures

Primary Outcomes (1)

• Wrinkles

  Improvement in Wrinkles Based on the Fitzpatrick Wrinkle Scale

  Baseline to Day 146

Secondary Outcomes (3)

• Rating of Non-Sequential Images

  Baseline, Day 28, and Day 56.

• Global Aesthetic Improvement Score

  Baseline to Day 28, 56, and 146

• Subject Satisfaction

  Baseline to Day 28, 56, and 146

Study Arms (1)

Treatment

EXPERIMENTAL

After baseline evaluation, all subjects will undergo a series of 3 facial treatments with the Secret Micro-Needle Fractional RF System® at 4 week intervals.

Device: Secret RF

Interventions

Secret RF DEVICE

A series of 3 facial treatments with the Secret Micro-Needle Fractional RF System® at 4 week intervals.

Treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

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.

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead
• Ilooda Co., Ltd.: collaborator

Study Sites (1)

West Dermatology Research Center

San Diego, California, 92121, United States

Location

Study Officials

• Mitchel P Goldman, MD

  Cosmetic Laser Dermatology and West Dermatology Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blinded-investigator assessments will be performed at Baseline and Days 28, 56, 146, and 180 to evaluate treatment efficacy for facial wrinkling. Of note, the blinded-investigators will be blinded to treatment settings and technique, and number of treatments.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects will receive up to three treatments at four week intervals to their full faces with the Secret RF device.

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 8, 2018
• Study Start: February 10, 2018
• Primary Completion: May 30, 2019
• Study Completion: June 30, 2019
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)