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What is the purpose of a clinical study?
The purpose of a clinical study (also called a "clinical trial" or "research trial") is to examine treatment options for specific health conditions. Although there are many types of clinical studies, all must conform to strict rules set by the U.S. Food and Drug Administration (FDA). These rules help protect the rights and safety of those who volunteer to take part in clinical research studies. |
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What will I need to do if I take part in the DRI-UP Clinical Study?
If you choose to take part in the DRI-UP Clinical Study, you will be asked to:
• Read and sign the Informed Consent form
• Schedule and attend follow-up visits
• Complete specific questionnaires and tests to document your progress
• Use only over-the-counter sweat management products, if desired
• Quickly report any problems to your physician |
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How does the Dri-Up Treatment work?
The Dri-Up Treatment does not involve any incisions. Prior to treatment, the underarm is numbed using a local anesthetic. Then, the Dri-Up Applicator is pressed against the underarm and electromagnetic energy is transmitted through the skin down to the precise area where sweat glands reside. This energy targets and deactivates glands in the underarm, which may result in long-term reduction in underarm sweat. |
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Are both underarms treated on the same day?
The Dri-Up Treatment is performed over the course of two to three separate treatment sessions, with each session scheduled at least 7 days apart. Both underarms are treated at each visit. |
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Can I have the Dri-Up Treatment without joining in the DRI-UP Clinical Study?
No, the Dri-Up Treatment is an investigational treatment and is currently only available through the DRI-UP Clinical Study. |
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Why will some patients initially undergo a simulated or "control" procedure?
The purpose of the DRI-UP Clinical Study is to determine whether patients undergoing the Dri-Up Treatment will experience a greater reduction in underarm sweating than patients undergoing a simulated (control) treatment. However, after the 6-month visit, patients who underwent the control treatment, and are still eligible, will have the opportunity to undergo the Dri-Up Treatment at no cost to them. |
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Do I need medical insurance to participate in the DRI-UP Clinical Study?
No, you do not need medical insurance to participate in the DRI-UP Clinical Study. If you qualify and choose to join the DRI-UP Clinical Study, you will receive all study-related care at no cost. This includes the Dri-Up Treatment, as well as all post-treatment care and follow-up. |
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How long will the DRI-UP Clinical Study last?
The study will last approximately 13 months. After the 6-month visit, patients who underwent the control treatment may exit the study and undergo the Dri-Up Treatment at no cost to them. |
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Where is the DRI-UP Clinical Study being conducted?
The DRI-UP Clinical Study is being conducted at several specialized dermatology centers throughout the U.S. Click here to see a list of current study locations. You can also visit the pre-screening questionnaire. The questionnaire will ask for your zip code and then search for DRI-UP study locations in your area. |
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Who is the company responsible for the DRI-UP Clinical Study?
The company sponsoring this study is Miramar Labs, Inc, headquartered in Sunnyvale, CA. Miramar Labs is a medical device company developing technologies for the treatment of dermatologic conditions. |
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What if I join the study and decide I do not want to participate anymore?
As with all clinical trials, your participation is completely voluntary and you may leave the study at any time. This will not affect your medical care or relationship with any of your doctors. |
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When will I know if I am eligible?
If you pass the initial pre-screening questionnaire, you will be able to enter your name and contact information, which will be sent to the local DRI-UP study location in your area. The Study Coordinator at your local site will then contact you within a couple of days to review your responses and help determine your eligibility. |
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What if I have other questions about the DRI-UP Clinical Study that are not
addressed on this website?
To see if you might qualify for the DRI-UP Clinical Study, and to be referred to a treatment center in your area, please take a moment to complete the pre-screening questionnaire. If you pass the pre-screening questionnaire, you will be able to enter your name and contact information, which will be sent to the local DRI-UP study location in your area. The Study Coordinator at your local site will then contact you within a couple of days to answer any additional questions you might have about the DRI-UP Clinical Study. |
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