Palmar Hyperhidrosis
Conditions
Keywords
Sweaty Hands
Brief summary
This is a pilot exploratory study to evaluate the safety and efficacy of TC-5214 in subjects with palmar hyperhidrosis.
Interventions
Investigational drug
OTHERPlacebo
Oral tablet containing no active drug.
Sponsors
Atacama Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study drug will be provided as oral tablets with active and placebo indistinguishable in product and packing characteristics.
Intervention model description
Subjects will be randomized (1:1:1) to one of three Treatment Arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has a clinical diagnosis of primary hyperhidrosis of the palms * Subject is currently drug-naïve for hyperhidrosis medications * Females must be post-menopausal, surgically sterile, or use an effective method of birth control.
Exclusion criteria
* Subject is pregnant, lactating, is planning to become pregnant during the study, or is less than one year postpartum. * Subject is a smoker within one year prior to Visit 1/Screening. * Subject has known history of secondary hyperhidrosis. * Subject has existence of neurological, psychiatric, endocrine, or other disease that can cause secondary hyperhidrosis or affect sweating. * Subject has known history of Sjögren's syndrome or Sicca syndrome. * Subject has used any of the following hyperhidrosis medications or therapies within the specified timeframe: 1. Iontophoresis to the palms within four weeks prior to baseline visit; 2. Botulinum toxin to the palms within one year prior to baseline visit; 3. Prior surgical procedures to the palms (e.g., sympathectomy, debulking of sweat glands); 4. Prior medical device treatment to the palms (approved or investigational); 5. Any treatments for hyperhidrosis within four weeks prior to baseline visit. * Subject is currently enrolled in an investigational drug or device study. * Subject has previously participated in a clinical study of dexmecamylamine or TC-5214. * Subject has used an investigational drug or investigational device treatment within 30 days prior to baseline. * Subject has a history of sensitivity to any of the ingredients in the study drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HDSS Success | Day 14 (End of Treatment) | Proportion of subjects with at least a 1, 2, or 3 point reduction in Hyperhidrosis Disease Severity Scale (HDSS) score from Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Sweat Production | Day 14 (End of Treatment) | Proportion of subjects with a ≥50% reduction in gravimetrically measured sweat production |
| Absolute change of Sweat Production | Day 14 (End of Treatment) | Absolute change from Baseline in gravimetrically measured sweat production. |
Other
| Measure | Time frame |
|---|---|
| Number of Subjects with Adverse Events (AEs) | From Baseline (Day 1) to End of Study (Day 22) |
Countries
United States
Outcome results
None listed