Hyperhidrosis
Conditions
Brief summary
Hyperhidrosis is a condition in which sweating is in excess of that required for normal regulation of body temperature. Commonly affected areas in primary hyperhidrosis include axillae, palms and soles. Secondary hyperhidrosis can affect scalp, face, neck, back, groin and legs. Hyperhidrosis can negatively impact, employment, relationships, or other aspects of quality of life. The investigators propose to investigate the use of a unique image-guided laser to specifically ablate eccrine sweat glands.
Interventions
DEVICELaser treatment
Iontophoresis of methylene blue is used to identify the sweat glands. An image guided fractional erbium laser is used to specifically target these glands for ablation.
Sponsors
Massachusetts General Hospital
Sciton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study involves a single group of patients with Hyperhidrosis. Left and right palms are randomized for treatment versus control (untreated).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects of ages between 18 and 65 years. 2. Subjects with any Fitzpatrick skin type. 3. Subjects who are proficient in the English language. 4. Willingness to participate in the study. 5. Willingness to undergo experimental procedure. 6. Informed consent agreement signed by the subject. 7. Willingness to follow the follow-up schedule. 8. Willingness not to use any other hyperhidrosis treatment to the tests sites during the study period (i.e. deodorant, at-home iontophoresis, Botox, MiraDry). 9. Patient rates symptoms at level "3" or "4" on the hyperhidrosis disease severity scale (HDSS, see below). 10. Subject in appropriate physical health to ride a stationary bicycle to the point of eliciting sweat. 11. No known allergy to iodine or potato starch
Exclusion criteria
1. Pregnancy 2. Subjects on systemic treatment for hyperhidrosis, such as anticholinergic drugs (e.g. glycopyrrolate), sedatives or tranquilizers, within the past 8 weeks. 3. Subjects who have undergone surgical excision of sweat glands or sympathectomy for hyperhidrosis. 4. Subjects with an underlying disorder, such as neurologic injury or disease affecting the autonomic system, vascular disorders and metabolic disorders (e.g. hyperthyroidism, diabetes mellitus) that can produce hyperhidrosis 5. Subjects with a history of coronary artery disease. 6. Subjects with a history of poor compliance or psychosis 7. Subjects taking SSRIs, SNRIs, TCAs, or MAOIs 8. Subjects with known hypersensitivity to methylene blue 9. Subjects with cardiac pacemaker or any other electrically powered implantable device. 10. Subjects not proficient in the English language. 11. Subject not in appropriate physical health to ride a stationary bicycle to the point of eliciting sweat. 12. Known allergy to iodine or potato starch.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gravimetric Measurements of Changes in Sweat Production | Assessed at baseline, week 1, week 2, week 4, month 3, and month 6 | Subjects will be asked to exercise using a stationary bike until sweating is observable. After drying the surface, a pre-weighted filter paper under occlusive dressing (Tegaderm) is applied to the test site for a period of five minutes, measured by a stopwatch. After five minutes, the Tegaderm and absorptive pad are removed. The absorptive pad and Tegaderm are weighed before and after sweating, and rate of sweat production is calculated. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 43.5 years STANDARD_DEVIATION 26.2 |
| Gravimetric measurements of changes in sweat production | 0.1275 grams STANDARD_DEVIATION 0.0028 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
None listed