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MiraDry® for Excessive Underarm Sweating (MiraDry Tx Trial)
N/A
Waitlist Available
Led By Malcolm Brock, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
This study will recruit patients diagnosed with focal hyperhidrosis with a known diagnosis of primarily axillary localization.
Patients diagnosed with focal hyperhidrosis with primarily axillary localization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
MiraDry Tx Trial Summary
This trial is testing a new treatment for primary hyperhidrosis, which is a condition characterized by excessive sweating. Patients often experience anxiety, social phobia, and depression as a result of the condition. The new treatment being tested is designed to address the psychological symptoms associated with the condition.
Who is the study for?
This trial is for individuals aged 18-29 with severe underarm sweating, rated 3 or higher on the Hyperhidrosis Disease Severity Scale. It's open to those who've tried non-invasive treatments before. Excluded are pregnant individuals, those unable to take oral antibiotics or use antiseptic washes, patients needing supplemental oxygen, with pacemakers/electronic implants, or allergies to lidocaine/hibiclens/epinephrine.Check my eligibility
What is being tested?
The Miradry Treatment is being tested in this study. This treatment targets excessive underarm sweating (axillary hyperhidrosis). The goal is to understand how effectively it reduces sweat and improves related psychosocial issues like anxiety and social avoidance.See study design
What are the potential side effects?
Potential side effects of the Miradry Treatment may include temporary swelling, pain at the treatment site, numbness in the underarm or upper arm skin which typically resolves over time.
MiraDry Tx Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with excessive sweating, mainly under my arms.
Select...
I have excessive sweating mainly under my arms.
Select...
I rate my condition as severe or very severe on the HDSS scale.
MiraDry Tx Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary effectiveness of the MiraDry treatment system (Hyperhidrosis Disease Severity Scale (HDSS)
MiraDry Tx Trial Design
1Treatment groups
Experimental Treatment
Group I: MiraDry ® treatmentExperimental Treatment1 Intervention
MiraDry ® is the trademarked name of a non-invasive thermolytic technology which utilizes a microwave energy-based mechanism targeted for eccrine gland reduction at the dermal-fat interface.
Each participant will be scheduled two MiraDry ® treatment appointments approximately three months apart.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,256 Previous Clinical Trials
14,820,047 Total Patients Enrolled
Malcolm Brock, MDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
200 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with excessive sweating, mainly under my arms.I need extra oxygen.I am unable to understand and give consent for treatment.I cannot take oral antibiotics or use antiseptic washes.I have excessive sweating mainly under my arms.Everyone will be evaluated using a scale to measure how severe their hyperhidrosis is.I am 29 years old or younger.I rate my sweating as severe or very severe.You are allergic to lidocaine, hibiclens with 4% chlorhexidine, or epinephrine.My past use of psychiatric meds or skin treatments won't exclude me from this study.I rate my condition as severe or very severe on the HDSS scale.I am between 18 and 29 years old.Everyone will be checked using a scale to measure how severe their hyperhidrosis (excessive sweating) is.We will only enroll patients available for both treatment visitsI have had non-invasive treatments before, but I can still join this study.
Research Study Groups:
This trial has the following groups:- Group 1: MiraDry ® treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
May I participate in this clinical investigation?
"The clinical trial is enrolling 24 adults (18-29 years) with axillary hyperhidrosis. To be considered, applicants must satisfy the following criteria: exhibiting a Hyperhidrosis Disease Severity Scale score of 3/4 or higher; no prior non-invasive treatment course involving psychiatric medication and topical therapies; available for both treatment visits. Upper age limit was established due to psychopathology often present in patients over 29 that may impede successful correction of sweating severity."
Answered by AI
Does the research team have any age restrictions for participation?
"Participants in this clinical trial must be between the ages of 18 and 29. For those younger than 18 or older than 65, there are separate studies available to them."
Answered by AI
Are there available slots for participants in this study?
"Citing information hosted on clinicaltrials.gov, the trial is not accepting participants at this time as it was originally opened in November 2014 and most recently updated August 2022. However, 8 other trials are currently open for enrolment."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
Minnesota
California
Other
How old are they?
18 - 65
What site did they apply to?
Johns Hopkins University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I have spoken with Dr. Brock about my hyperhydrosis and how I’ve tried several prescription strength deodorants but never seen satisfactory results. I’m uncomfortable daily as I feel the sweating occur in my underarms and struggle with shopping, for the thought of how my hyperhydrosis will ruin my shirts constantly lingers in the back of my mind. I’ve long considered getting this treatment, but insurance and finances were an issue. I greatly desire a better quality of life, and this trial will hopefully lead me towards it.
PatientReceived 1 prior treatment
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