AgingNCT03426098
Secret Micro-Needle Fractional RF System® for the Treatment of Facial Wrinkles
A study testing Secret RF in people with Aging and Wrinkle, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- What is being tested?
- Secret RF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Dermatology Research Center
San Diego, California, 92121
About this study
Official title: A Prospective, Single-center, Investigator-blinded Trial to Evaluate the Safety and Efficacy of Secret Micro-Needle Fractional RF System® for the Treatment of Facial Wrinkles
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).
Read the 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-Needle Fractional RF System® at 4 week intervals.
Blinded-investigator and subject self-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. Safety will be evaluated by subject diaries, as well as investigator- and subject-rated evaluations of adverse events at all follow-up visits. Mandatory standard 2D digital photography, Canfield VISIA and VECTRA 3D digital photography will be performed at baseline and at each office visit.
- Being tested
- Secret RF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secret RFDevice
A series of 3 facial treatments with the Secret Micro-Needle Fractional RF System® at 4 week intervals.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Secret RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrinkles
Improvement in Wrinkles Based on the Fitzpatrick Wrinkle Scale
Measured: Baseline to Day 146
Secondary outcomes (3)
Rating of Non-Sequential Images
Ratings of non-sequential images of subjects at baseline, Day 28, and Day 56. Improvement is defined as a minimum improvement by a score of 1 on the Fitzpatrick Wrinkle Scale or Modified Fitzpatrick Wrinkle Scale as graded by two out of three blinded evaluators, who will be blinded to treatment settings and technique, and number of treatments
Measured: Baseline, Day 28, and Day 56.
Global Aesthetic Improvement Score
Investigator Assessed Global Aesthetic Improvement Score
Measured: Baseline to Day 28, 56, and 146
Subject Satisfaction
Subject-assessed Satisfaction with Facial Appearance scale (FACE-Q)
Measured: Baseline to Day 28, 56, and 146
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start10 Feb 2018
- Primary completion30 May 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will receive up to three treatments at four week intervals to their full faces with the Secret RF device.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- Ilooda Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Mitchel P Goldman, MD, Principal investigator, Cosmetic Laser Dermatology and West Dermatology Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426098
- Sponsor's protocol ID
- 0922-1228
- Status last verified
- May 2019
- First submitted
- 2 Feb 2018
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Investigator-blinded Trial to Evaluate the Safety and Efficacy of Secret Micro-Needle Fractional RF System® for the Treatment of Facial Wrinkles
- ClinicalTrials.gov ID
- NCT03426098
- Acronym / sponsor ID
- 0922-1228
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- Ilooda Co., Ltd.
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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-Needle Fractional RF System® at 4 week intervals.
Blinded-investigator and subject self-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. Safety will be evaluated by subject diaries, as well as investigator- and subject-rated evaluations of adverse events at all follow-up visits. Mandatory standard 2D digital photography, Canfield VISIA and VECTRA 3D digital photography will be performed at baseline and at each office visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will receive up to three treatments at four week intervals to their full faces with the Secret RF device.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Secret RFAfter baseline evaluation, all subjects will undergo a series of 3 facial treatments with the Secret Micro-Needle Fractional RF System® at 4 week intervals. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secret RFA series of 3 facial treatments with the Secret Micro-Needle Fractional RF System® at 4 week intervals. | Device | Treatment |
Primary outcome
Wrinkles
Time frame: Baseline to Day 146
Improvement in Wrinkles Based on the Fitzpatrick Wrinkle Scale
3 secondary outcomes
Rating of Non-Sequential Images
Time frame: Baseline, Day 28, and Day 56.
Global Aesthetic Improvement Score
Time frame: Baseline to Day 28, 56, and 146
Subject Satisfaction
Time frame: Baseline to Day 28, 56, and 146
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchel P Goldman, MD principal investigator
Cosmetic Laser Dermatology and West Dermatology Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Secret RF in people with Aging and Wrinkle, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrinkles (time frame: Baseline to Day 146). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.