169 Ramapo Valley Rd., LL104, Oakland, NJ

Clinical Research Study

Do You Have Crow’s Feet?
We are looking for volunteers to participate in a study.

We are inviting adults between the ages of 35 and 75 who show visible signs of aging around the eyes (commonly known as crow’s feet) to participate in a clinical research study.

If you are interested in participating, please read the information below, as well as the
Consent document below, for more detailed information about criteria for qualifying and
the study itself.

After reviewing these materials, if you believe you are a good candidate for the study and want to participate, call us at 201-368-3800 to schedule your first visit so we can evaluate you and enroll you in the study if we agree that you qualify. If so, please also complete out Client Information & Medical History and HIPAA Forms and bring them to your first appointment. Please do not sign the Consent; we will discuss that at the first visit.

Why we are conducting the research?

As we age our skin shows visible signs of the aging process such as lines and wrinkles. Many treatments are available to help slow down this process. Some take the form of over the counter creams while others require treatments from a physician using strong cosmeceuticals or specialist treatments with devices. The reason we are doing this study is to see how effective a medical device and procedure is in treating these visible signs of aging, particularly around the eye area. The medical device we are testing is a microneedling device called NXT. The NXT is made by RefineUSA a company based in Florida. NXT is an advanced design of an existing product that has been approved for use in Europe for several years.

We want to confirm that the improvements made to the device give better results. We are also carrying out a study to be able to correctly register the device for use in Europe.

Duration of the study

You will be involved in the study for 16 weeks. It will be necessary for you to come to the clinic on 5 separate occasions. The first 4 visits will include a treatment and you will be in the clinic for between 1 and 1 ½ hours. On the fifth and final visit, you will be in the clinic for 30‐45 minutes.

What will happen during the study?

Everyone in the study receives the actual treatment; there is no control or placebo group. If you qualify for the study you will receive 4 microneedling treatments to your face, one treatment every 4 weeks. During the research, you will make 5 visits to the clinic. For all visits to the clinic we will ask you to remove your make‐up entirely before you arrive, Men must be freshly shaved.

During the study;

  • You will be asked some general questions about your current medical history – you will have a brief medical examination
  • You will have standard photographs called “VISIA” and 3D photographs called “PRIMOS” taken of your face. VISIA, is a standard photographic procedure; PRIMOS takes a very detailed picture of your skin. Both procedures are painless and non‐invasive.
  • You will have your skin visually assessed by the research staff.
  • You will complete a general questionnaire about your skin
  • You will undergo the treatment. The treatment involves applying a numbing cream to the area around your eyes (crowsfeet). The numbing cream takes up to 30 minutes to numb the treatment area. After 30 minutes the cream is removed and your face will be cleansed again.
  • You will then undergo the treatment. The treatment involves making many, very tiny, microscopic punctures into the epidermis of the skin using very fine sterile needles. To do this the device is moved over your skin repeatedly to puncture the epidermis. People who experience the treatment say that it feels like their skin is being rubbed with fine sandpaper while others describe the feeling of an electronic toothbrush being moved across your skin.
  • Afterwards your skin will be cleansed and research staff will apply a moisturizer and sun block. You will be given moisturizer and sunblock to take home with you.
  • You will be asked to complete a diary for 7 days recording how your skin feels after the treatment.

To Be in this Study

  • You will need to be between 35 and 75 years of age.
  • In general ‐ good health.
  • Have visible signs of aging to your face, particularly around the eyes (crowsfeet).
  • Willing to not use anti‐aging products that contain active ingredients such as retinol and glycolic acid on your face or undergo any other aesthetic procedures such as (Botox, Fillers, peels, laser treatment) for the duration of the study.
  • Willing to attend the study center on 5 occasions, four of which will be to undergo the treatment.
  • Willing to record your experiences of the treatment procedure and how your skin looks and feels for 7 days after the procedure.
  • Willing to have your face photographed for purposes of clinical evaluation at each visit.
  • Willing to not undergo any other facial treatments during the study period.

You will NOT qualify for this study if;

  • You have a known history of hemophilia or other clotting bleeding disorders.
  • You are taking anticoagulant therapies such as warfarin or heparin or low dose aspirin as prescribed by your physician.
  • You are allergic to Lidocaine.
  • You are suffering from an active skin infection or eczema or skin rashes of the face.
  • You have keloid scars, HPV or birthmarks in the treatment area.
  • You are suffering from a known malignancy or are undergoing or about to undergo treatments using chemotherapy, radiotherapy or high dose corticosteroids.
  • You have undergone Botox injections around the eyes within the last 6 months.
  • You have undergone filler injections around the eyes within the last 2 years.
  • You have undergone plastic surgery of the face in the last 6 months.
  • You suffer from systemic infections such as hepatitis.
  • If you are pregnant or plan to become pregnant during the study period or are currently breastfeeding.
  • You are enrolled in another clinical study.
  • If you have a planned hospital admission and/or surgical procedure for an illness or disease which existed before enrollment.

The study is being carried out by Dr H. William Song, MD Omni Aesthetics, 169 Ramapo Valley Rd STE LL104. Oakland, NJ 07436 on behalf of the study sponsor, Refine USA, 340 3rd Avenue South Ste #C, Jacksonville Beach, FL 32250. The title of this study is an; “Open label, single center, evaluating the effectiveness of an automated microneedling device in improving periorbital wrinkles.

For further information call 201-368-3800

This information has been reviewed and approved by IRB Company, Inc. which is a committee whose task it is to make sure that research participants are protected from harm. If you wish to find more about the IRB or if you have concerns or complaints about the research, or wish to ask questions about your rights as a study subject as provided in the Subject’s Bill of Rights you may contact:

IRB Company, Inc.
Phone: 1‐877‐680‐4138
E‐Mail: irb@irbco.com
Website: www.irbco.com

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