Status:
COMPLETED
Exploratory Study to Assess the Efficacy and Safety of TC-5214 in the Treatment of Subjects With Palmar Hyperhidrosis
Lead Sponsor:
Atacama Therapeutics
Conditions:
Palmar Hyperhidrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
- 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
- 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:
- Iontophoresis to the palms within four weeks prior to baseline visit;
- Botulinum toxin to the palms within one year prior to baseline visit;
- Prior surgical procedures to the palms (e.g., sympathectomy, debulking of sweat glands);
- Prior medical device treatment to the palms (approved or investigational);
- 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.
Key Trial Info
Start Date :
December 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03404570
Start Date
December 21 2017
End Date
January 18 2019
Last Update
November 21 2019
Active Locations (3)
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1
Site 02
San Diego, California, United States, 92123
2
Site 03
St Louis, Missouri, United States, 63122
3
Site 01
Norfolk, Virginia, United States, 23502