(245 days)
Not Found
No
The description focuses on the mechanical aspects of a microneedling device and does not mention any AI or ML components.
Yes.
The device is intended to improve the appearance of periorbital wrinkles, which constitutes a therapeutic effect.
No
The device is a microneedling device intended for treatment to improve the appearance of periorbital wrinkles, not for diagnosis.
No
The device description clearly states it is a handheld instrument with physical components like needles, a motor, and a power supply, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Rejuvapen NXT Function: The Rejuvapen NXT is a microneedling device that physically punctures the skin to improve the appearance of wrinkles. It does not examine specimens from the body to provide diagnostic information.
- Intended Use: The intended use clearly states it's a "treatment to improve the appearance of periorbital wrinkles." This is a therapeutic or cosmetic application, not a diagnostic one.
The information provided describes a device used for a physical treatment on the body, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The Rejuvapen NXT is a microneedling device and accessories intended to be used as a treatment to improve the appearance of periorbital wrinkles in Fitzpatrick skin types I-IV. The Rejuvapen NXT is intended for use on adults at least 22 years of age.
Product codes (comma separated list FDA assigned to the subject device)
QAI
Device Description
The Rejuvapen is a handheld instrument that contains a Single Use micro needle cartridge containing 12 stainless steel microneedles in a circular arrangement with an adjustable microneedle depth of up to 2.5 mm. The needles create very small punctures in the epidermal and dermal layers of the skin. The device is powered by a medical grade wall plug-in supply. An adjustment is provided for a variable speed motor that controls the frequency of the puncture process with a maximum puncture frequency of 110 Hz + 2 %.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital region
Indicated Patient Age Range
adults at least 22 years of age
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D) / Physician's office
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A clinical study was conducted at a single center with 52 healthy volunteers with facial ageing. Subjects were assessed at baseline and 30 days after the last treatment, on Day 120. At each visit digital photographs (VISIA) were taken of the subject's face. At the end of the study the digital images of the subject's face were masked and randomized independently by 2 physicians using the Lemperle grading scale (periorbital region).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical performance testing: A clinical study was conducted at a single center. 52 healthy volunteers with facial ageing were recruited. After informed consent, subjects underwent 4 micro needling sessions 4 weeks apart. Subjects were assessed at baseline and 30 days after the last treatment, on Day 120. Forty-six subjects (88%) completed all treatment visits and attended follow up.
Physician Measurements of safety: There were 20 adverse events during the study, that occurred in 12/52 subjects (23%) The adverse events were judged to be mild by the principle investigator. Erythema immediately after treatment was graded by the physician as predominantly minor or mild in subjects, and no subjects were graded as severe.
Subject measurement of safety: Subject evaluation of pain and discomfort during treatment indicated a mean pain score of 2.1 over the four treatments (based on a 0-10 scale) and a mean discomfort score of = 1 grade: 19/45, 42% (95% CI: 35.2%, 67.5%).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4430 Microneedling device for aesthetic use.
(a)
Identification. A microneedling device for aesthetic use is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical specifications and needle characteristics must be identified, including needle length, geometry, maximum penetration depth, and puncture rate.
(2) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Accuracy of needle penetration depth and puncture rate;
(ii) Safety features built into the device to protect against cross-contamination, including fluid ingress protection; and
(iii) Identification of the maximum safe needle penetration depth for the device for the labeled indications for use.
(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life.
(5) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of all electrical components of the device.
(6) Software verification, validation, and hazard analysis must be performed for all software components of the device.
(7) The patient-contacting components of the device must be demonstrated to be biocompatible.
(8) Performance data must validate the cleaning and disinfection instructions for reusable components of the device.
(9) Labeling must include the following:
(i) Information on how to operate the device and its components and the typical course of treatment;
(ii) A summary of the device technical parameters, including needle length, needle geometry, maximum penetration depth, and puncture rate;
(iii) Validated methods and instructions for reprocessing of any reusable components;
(iv) Disposal instructions; and
(v) A shelf life.
(10) Patient labeling must be provided and must include:
(i) Information on how the device operates and the typical course of treatment;
(ii) The probable risks and benefits associated with use of the device; and
(iii) Postoperative care instructions.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 9, 2020
Refine USA LLC % Wayne Glover President TechniReg, Inc 19404 Pine Valley Drive Odessa, Florida 33556-3955
Re: K192138
Trade/Device Name: Rejuvapen NXT Regulation Number: 21 CFR 878.4430 Regulation Name: Microneedling device for aesthetic use Regulatory Class: Class II Product Code: QAI Dated: February 28, 2020 Received: March 6, 2020
Dear Wayne Glover:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kimberly M. Ferlin, Ph.D. Assistant Director (Acting) DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192138
Device Name Rejuvapen NXT
Indications for Use (Describe)
The Rejuvapen NXT is a microneedling device and accessories intended to be used as a treatment to improve the appearance of periorbital wrinkles in Fitzpatrick skin types I-IV. The Rejuvapen NXT is intended for use on adults at least 22 years of age.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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a
Image /page/3/Picture/1 description: The image shows the RefineUSA logo on the left and the text "510(k) Summary" on the right. The RefineUSA logo consists of a stylized letter R in blue, with the company name written in gray next to it. The text "510(k) Summary" is written in a bold, sans-serif font. The image is likely a document header or title page for a medical device submission.
This 510(k) Summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| Summary Date: | April 8, 2020 | ||
|---|---|---|---|
| Manufacturer: | Refine USA LLC | ||
| Telephone: | 866-590-5533 | ||
| Establishment | |||
| Registration No.: | 3006033709 | ||
| Contact Person: | Mr. Brian Smith | ||
| President | |||
| Phone: (904) 629-0100 | |||
| Fax: (888) 842-0395 | |||
| Trade Name: | Rejuvapen™ NXT | ||
| Common Name: | Powered Microneedle Device | ||
| Classification Name: | Microneedling device for aesthetic use (21 CFR 878.4430) | ||
| Product Code: | QAI | ||
| Equivalence / | |||
| Predicate Device: | Substantial equivalence to the following legally marketed predicate devices is | ||
| claimed: | |||
| Device Name: | 510(k) No.: | Date: | |
| SkinPen® Precision System | DEN160029 | 03/01/2018 | |
| Description: | The Rejuvapen is a handheld instrument that contains a Single Use micro needle | ||
| cartridge containing 12 stainless steel microneedles in a circular arrangement | |||
| with an adjustable microneedle depth of up to 2.5 mm. The needles create very | |||
| small punctures in the epidermal and dermal layers of the skin. The device is | |||
| powered by a medical grade wall plug-in supply. An adjustment is provided for a | |||
| variable speed motor that controls the frequency of the puncture process with a |
The Rejuvapen may be used with the operator and/or patient in any position that is comfortable. There are no restrictions for other nearby persons.
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| Caution: Federal law restricts this device to sale by or on the order of a physician. This is a Class II device (USA). | |
|---|---|
| Intended Use: | The Rejuvapen NXT is a microneedling device and accessories intended to be used as a treatment to improve the appearance of periorbital wrinkles in Fitzpatrick skin types I-IV. The Rejuvapen NXT is intended for use on adults at least 22 years of age. |
| Predicate Device: | The Rejuvapen NXT characteristics with its included accessories and intended use are compared to the following predicate device: |
| SkinPen® Precision System (DEN160029) manufactured by Bellus Medical, LLC. | |
| Please refer to data in the comparison chart for comparison of the design, materials, chemical composition, packaging, intended use, mechanical performance and other characteristics of the subject device to those of the predicate devices. | |
| Biocompatibility: | The biocompatibility endpoints were evaluated to the following standards: |
| Cytotoxicity - ISO 10993-5 Skin irritation – ISO 10993-10 Skin sensitization - ISO 10993-10 Pyrogenicity - USP Acute Systemic Toxicity - ISO 10993-11 | |
| EMC: | Electromagnetic Compatibility testing was performed on the device and its power supply adapter by an NRTL and complies with IEC 60601-1-2 Medical Electrical Equipment, Electromagnetic Compatibility. |
| Essential Performance: | The Rejuvapen NXT has been tested for electromagnetic immunity and emissions. The basic safety and essential performance of the device is maintained if the user follows the rules, distances and exclusions described in the information and tables that follow. |
| The essential performance of Rejuvapen NXT microneedling device is defined as: | |
| a) Needle protrusion: Maximum needle protrusion is a needle protrusion setting of 2.5 + 0.25 mm. | |
| Note: As the dial for the needle protrusion setting is mechanical, this needle protrusion cannot be influenced by EMC, electronic or electric phenomena. | |
| b) Puncture frequency: Maximum puncture frequency of 110 Hz + 2 % | |
| Electrical Safety: | Electrical Safety testing was performed on the device and its power adapter by |
| an NRTL and fulfil the requirements of ANSI AAMI ES60601-1:2005/(R)2012 + | |
| A1:2012 + C1:2009(R)2012 + A2:2010(R)2012 (Consolidated Text) Medical | |
| Electrical Equipment - Part 1: General Requirements for Basic Safety and | |
| Essential Performance (IEC 60601-1:2005, MOD). | |
| Shelf Life and | |
| Sterilization | |
| Validation: | The shelf life of the handheld unit and microneedle cartridge is 2 years and was |
| verified by testing in accordance with the shelf life and sterilization validation | |
| test report. References include ISO 11607 and FDA guidance document | |
| 'Submission and Review of Sterility Information in Premarket Notification | |
| (510(k)) Submissions for Devices Labeled as Sterile', March 2016. | |
| Technical | |
| Specifications: | Needle Length: 3.0mm - includes length inside molded housing |
| Geometry: 12 needles in a circular arrangement outer circle of 8, inner circle of 4 | |
| Maximum Penetration Depth Setting: 2.5mm | |
| It is not recommended to use the device at depths greater than 1.3mm | |
| Puncture Rate Frequency: User adjustable in 9 steps from 80 to 110 Hz | |
| (4800 to 6600 RPM) | |
| Needle Penetration Depth Accuracy: ±0.25mm. | |
| Puncture Rate Accuracy: ±2% |
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General controls and mitigation measures
To support substantial equivalence of the Rejuvapen NXT Microneedling device system, it has undergone non-clinical performance tests in line with recognized standards in terms of general requirements, biocompatibility, electrical safety and software.
The following non-clinical performance data is provided in support of the substantial equivalence determination
| Identified Risk to Health | Mitigation Measures | Substantiation |
|---|---|---|
| Safety profile | Biocompatibility | |
| evaluation | ISO 10993-5, ISO 10993-7, ISO 10993- | |
| 10, ISO 10993-11, USP 40 part 151, and | ||
| ISO 10993-12 | ||
| Labeling | ISO 15223-1:2012, EN 1041:2008, | |
| IEC 82079-1:2012, IEC 62366:2007 | ||
| Cross contamination | ||
| and infection | Sterilization validation | ISO11135-1:2007 |
| ISO/TS11135-2:2008 | ||
| ISO11737-1:2006 | ||
| Reprocessing validation | A cleaning validation and a low-level | |
| disinfection validation was performed | ||
| (Reprocessing Medical Devices in Health | ||
| Care Settings: Validation Methods and | ||
| Labeling). In addition, the use of a | ||
| protective sleeve is required. | ||
| Non-clinical performance | ||
| testing | Non-clinical performance data | |
| demonstrates that the device performs as | ||
| intended under anticipated conditions of | ||
| use. | ||
| The following performance characteristics | ||
| were tested: | ||
| i. Accuracy of needle penetration depth | ||
| and puncture rate in pig skin | ||
| ii. Safety features built into the device to | ||
| protect against cross-contamination, | ||
| including fluid ingress protection due to a | ||
| safety membrane; and | ||
| iii. Identification of the maximum needle | ||
| penetration depth for the device in pig | ||
| skin | ||
| Shelf life testing | Performance data supports the shelf life | |
| of the device by demonstrating continued | ||
| sterility, package integrity, and device | ||
| functionality over the intended shelf life | ||
| according to ISO 11607-1, ISO11607-2 | ||
| and ISO 11737-2 | ||
| Labeling | ISO 15223-1 | |
| EN 1041 | ||
| IEC 82079-1 | ||
| IEC62366 | ||
| Electrical shock or | ||
| Electromagnetic | ||
| interference with other | ||
| devices | EMC testing and electrical | |
| safety testing | IEC / ES60601-1 | |
| IEC60601-1-2 | ||
| IEC60601-1-6 | ||
| Labeling | ISO 15223-1 | |
| EN 1041 | ||
| IEC 82079-1 | ||
| IEC62366 | ||
| Non-clinical performance | ||
| testing | Non-clinical performance data | |
| demonstrates that the device performs as | ||
| intended under anticipated conditions of | ||
| use. | ||
| The following performance characteristics | ||
| were tested: | ||
| i. Accuracy of needle penetration depth | ||
| and puncture rate in pig skin | ||
| ii. Safety features built into the device to | ||
| protect against cross-contamination, | ||
| including fluid ingress protection due to a | ||
| safety membrane; and | ||
| iii. Identification of the maximum safe | ||
| needle penetration depth for the device in | ||
| pig skin | ||
| Exceeding safe penetration | ||
| depth | ||
| Mechanical failure | ||
| Software malfunction | Technological | |
| characteristics | Non-clinical performance data | |
| demonstrates that the device performs as | ||
| intended under anticipated conditions of | ||
| use. | ||
| The manufacturer has set tolerances for | ||
| maximum needle depth penetration and | ||
| puncture rate and has performed bench | ||
| testing to demonstrate the efficacy of | ||
| fluid ingress protection. | ||
| The following performance characteristics | ||
| are tested: | ||
| i. Accuracy of needle penetration depth, | ||
| maximum needle depth penetration and | ||
| puncture rate was tested in a clinically | ||
| suitable substrate porcine skin. Two | ||
| penetration depths of 0.5mm and 2.5mm | ||
| were tested at frequencies (puncture | ||
| rate) of 80 and 110Hz using aged | ||
| cartridges and aged devices to verify the | ||
| accuracy of the penetration depth, | ||
| maximum permissible depth and puncture | ||
| rate. | ||
| A tolerance was set of ± 0.25mm for | ||
| needle penetration and a 2% tolerance of | ||
| puncture rate. In all tests and in all | ||
| variations the accuracy of needle | ||
| penetration depth and puncture rate were | ||
| within the expected tolerances. The | ||
| maximum needle depth penetration of the | ||
| exceed the tolerances set by the | ||
| manufacturer. | ||
| ii. Safety features built into the device to | ||
| protect against cross-contamination, | ||
| including fluid ingress protection. The | ||
| micro needling cartridge contains a safety | ||
| membrane (seal) that was tested under | ||
| laboratory conditions. Testing of the seal | ||
| under a worst-case scenario (maximum | ||
| puncture rate and needle penetration | ||
| depth) did not result in the penetration of | ||
| viral particles, protein or hemoglobin | ||
| markers through the seal to the chamber | ||
| of the device. | ||
| iii. Identification of the maximum needle | ||
| penetration depth for the device in pig | ||
| skin. | ||
| Shelf life testing | ISO 11607-1 | |
| ISO 11607-2 | ||
| Labeling | ISO 15223-1 | |
| EN 1041 | ||
| Software verification, | ||
| validation and hazard | ||
| analysis | IEC 62304 | |
Summary of Risk and mitigation measures
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Technological Characteristics
| Property: | Rejuvapen NXT | SkinPen® Precision
System | Significant differences |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Manufacturer | Refine USA, LLC
340 3rd Avenue South
Suite C
Jacksonville Beach, FL
32250 | Bellus Medical, LLC
4505 Excel Parkway
Suite 100
Addison, TX 75001 | Not Applicable |
| Device Tradename | Rejuvapen NXT | SkinPen® Precision
System | Not Applicable |
| 510(k) Number | K192138 | DEN160029 | Not Applicable |
| Device
Classification
Name | Microneedling device
for aesthetic use | Microneedling device for
aesthetic use | Identical |
| Device
Product Code | QAI | QAI | Identical |
| Device
Classification | Class II | Class II | Identical |
| Regulation Number | 21CFR 878.4430 | 21CFR 878.4430 | Identical |
| Use | Prescription Only | Prescription Only | Identical |
| Intended Location
of Use | Face | Face | Identical |
| Indications for Use
and Intended Use | The Rejuvapen NXT is
a microneedling device
and accessories
intended to be used as
a treatment to improve
the appearance of
periorbital wrinkles in
Fitzpatrick skin types I-
IV. The Rejuvapen
NXT is intended for use
on adults at least 22
years of age. | SkinPen® Precision
System is a microneedling
device and accessories
intended to be used as a
treatment to improve the
appearance of facial acne
scars in adults aged 22
years or older | Dissimilar - clinical data was
provided to support the
indication |
| Geometry | 12 needles in a circular
arrangement:
outer circle of 8, inner
circle of 4 | 14 needles in a circular
arrangement:
outer circle of 7, inner
circle of 6, middle has 1 | Dissimilar - Non clinical
performance testing using pig
skin demonstrates that the
needle geometry of the
proposed device is uniform
and does not raise any
different questions in relation
to safety, compared to the
predicate device. |
| Property: | Rejuvapen NXT | SkinPen® Precision System | Significant differences |
| Needle protrusion settings | 0 – 2.5mm | 0 – 2.5mm | Identical |
| Max. Penetration Depth | 2.5mm | 2.5mm | Identical |
| Puncture Rate Frequency | 80Hz to 110Hz user adjustable, 9 regulated speeds | 105Hz to 136Hz unregulated | Dissimilar - Proposed device does not exceed the frequency of the predicate device. Bench testing was provided to support the difference in technology. |
| Treatment Protocol | 4 treatments spaced 4 weeks apart | 3 treatments spaced 4 weeks apart | Identical |
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Substantial Equivalency and Comparison of Technological Similarities and Differences:
Key Similarities:
-
- The device classification (generic description) and basic technologies are equivalent in that both devices are micro needling devices containing more than 1 needle that mechanically punctures and injures the skin for aesthetic use.
-
- Both devices are by prescription use only.
-
- Both use a circular arrangement for the micro-needles.
- Both have a maximum penetration depth of 2.5mm. 4.
-
- Both use treatment tips that are disposable and for single use only.
Differences:
Althouqh the devices share the basic generic description and technologies they do differ in several areas.
- a. Indication
- b. Geometry and needle count
- c. Puncture rate frequency
These differences have been addressed by the manufacturer through the applicable safety standards, general controls, non-clinical, and clinical testing.
Clinical performance testing
A clinical study was conducted to support the safe and effective use of the Rejuvapen NXT Microneedling device for the treatment of Periorbital wrinkles.
The study was conducted at a single center. 52 healthy volunteers with facial ageing were recruited. After informed consent, subjects underwent 4 micro needling sessions 4 weeks apart. Subjects were assessed at baseline and 30 days after the last treatment, on Day 120.
11
The subject's face was cleansed with cleanser to remove all traces of make-up. A topical anesthetic (Numbmaster; 5% Lidocaine) was applied to the periorbital region for 30 minutes, as per the manufacturer's instructions. After 30 minutes the topical anesthetic was removed.
A standard microneedle cartridge containing 12 stainless steel microneedles (maximum 2.5 mm length, 32 gauge) was used to achieve pinpoint bleeding over the periorbital treatment area. The operator was instructed to start at a needle protrusion setting of 0.5 mm and gradually increase the depth until pinpoint bleeding was observed, with a maximum depth of 1.3 mm. After treatment the skin was cleansed with warm water and sterile gauze. A physical sunblock cream with SPF 40 was applied to the subject's skin.
Forty-six subjects (88%) completed all treatment visits and attended follow up. One subject was withdrawn as they had commenced Apixiban, an anticoagulant, two withdrew for no reason and did not return the research staff calls, one withdrew to undergo additional aesthetic treatments, one withdrew for personal reasons and one subject withdrew because they 'did not like the treatments'.
The mean age of the subject was 57 years (range 37-72 vears). Six males, 46 females, Fitzpatrick phototypes (FP) ranged from 1-4. Six of the subjects identified as Hispanic the remainder were white Caucasian. Five of the subjects were smokers (see table 1).
Table 1 Subject demographics at baseline
| N | Mean age | Age range | M:F | Hispanic | FP I | FP II | FP III | FP IV | FP V | FP VI |
|---|---|---|---|---|---|---|---|---|---|---|
| 52 | 57 | 37-72 | 6:46 | 6 | 3 | 20 | 22 | 7 | - | - |
MEASUREMENT OF SAFETY
Physician measurement of safety
Immediately after each micro needling procedure the research staff graded the amount of visible erythema in the treatment area. Grading was carried out using a 5-point grading scale; whereby none was equivalent to "No erythema or redness. Skin is normal color" to Severe; "Bright or dark red color to the skin. Skin is severely red."
Subjects measurement of safety
Subjects also graded erythema, pain and discomfort experienced during the treatment. A descriptive grading scale was used for subjects to evaluate their erythema with the addition of photography. This scale was also used for subjects to record their erythema at home. Pain and discomfort were recorded using a visual analoque scale (0-10) where 0 was equivalent to "no discomfort" to 10, "most intense pain ever" and "most discomfort ever". This grading structure was also used to record changes to pain and discomfort at home. In addition, skin peeling was assessed by the subject from day 3 to day 8 using a visual analogue scale.
From commencement of the study to study close out adverse events were recorded and monitored by the research staff.
MEASUREMENT OF EFFECTIVENESS
Physician measurement of effectiveness
At each visit digital photographs (VISIA) were taken of the subject's face. At the end of the study the digital images of the subject's face were masked and randomized independently by 2
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physicians using the Lemperle grading scale (periorbital region). *Lemperle G, Holmes RE, Lemperle SS. A Classification of Facial Wrinkles. Plastic and reconstructive surgery. 2001 Nov 1;108(6):1735-50.
Subject measurement of effectiveness
Subjects were asked to grade their skin at baseline in respect to periorbital lines and wrinkles, and pigmentation. Thirty days after the last treatment, subjects were asked to grade their treatment response.
RESULTS
Physician Measurements of safety
There were 20 adverse events during the study, that occurred in 12/52 subjects (23%) The adverse events were judged to be mild by the principle investigator.
Fourteen (14/20, 70%) of the 20 AEs were reports of bruising in the treatment area lasting between 1-7 days. Only one event (1/20, 5%) reported bruising under both eyes and the remainder were singular occurrences, either left or right eye areas. Swelling in the treatment area was reported in two (2/20, 10%) of subjects and blotchy skin and bruising were reported in one subject (1/20(5%)). One subject (1/20(5%)) reported 'watery eyes' and a post-treatment allergic response after three treatment visits. There were no unrelated adverse events.
All the incidents were self-limiting and required no intervention from study staff.
Erythema immediately after treatment was graded by the physician as predominantly minor or mild (see table 2) in subjects (with the remainder of subjects graded as moderate. No subjects were graded as severe.
| Physician Erythema grading - Immediately post treatment | ||||||
|---|---|---|---|---|---|---|
| None | Minor | Mild | Moderate | Severe | Number of | |
| subjects | ||||||
| Treatment 1 | 0 | 25 (48%) | 22 (42%) | 5 (10%) | 0 | 52 |
| Treatment 2 | 0 | 30 (61%) | 17 (35%) | 2 (4%) | 0 | 49 |
| Treatment 3 | 0 | 29 (63%) | 15 (33%) | 2 (4%) | 0 | 46 |
| Treatment 4 | 0 | 32 (70%) | 13 (28%) | 1 (2%) | 0 | 46 |
| Table 2 Physician Erythema grading - Immediately post treatment | |||
|---|---|---|---|
| ----------------------------------------------------------------- | -- | -- | -- |
Subject evaluation of pain and discomfort during treatment indicated a mean pain score of 2.1 over the four treatments (based on a 0-10 scale) with a range from 0-7, and a mean discomfort score of