Clinical trial NCT03404570: Exploratory Study to Assess the Efficacy and Safety of TC-5214 in the Treatment of Subjects With Palmar Hyperhidrosis
Official title: A Double-Blind, Randomized, Placebo-Controlled Exploratory Study to Assess the Efficacy and Safety of TC-5214 in the Treatment of Subjects With Moderate to Severe Palmar Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Palmar Hyperhidrosis
Keywords: Sweaty Hands
Lead sponsor: Atacama Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized (1:1:1) to one of three Treatment Arms
Primary purpose: TREATMENT

Brief summary: This is a pilot exploratory study to evaluate the safety and efficacy of TC-5214 in subjects with palmar hyperhidrosis.


Eligibility criteria: 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.

Primary outcomes:
measure: HDSS Success
timeFrame: Day 14 (End of Treatment)
Secondary outcomes:
measure: Reduction in Sweat Production
timeFrame: Day 14 (End of Treatment)
measure: Absolute change of Sweat Production
timeFrame: Day 14 (End of Treatment)
Other outcomes:
measure: Number of Subjects with Adverse Events (AEs)
timeFrame: From Baseline (Day 1) to End of Study (Day 22)
Locations:
city: San Diego
country: United States
facility: Site 02
state: California
city: Saint Louis
country: United States
facility: Site 03
state: Missouri
city: Norfolk
country: United States
facility: Site 01
state: Virginia
Study officials:
References: