Exploratory Study to Assess the Efficacy and Safety of TC-5214 in the Treatment of Subjects With Palmar Hyperhidrosis
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/2/2018 |
Start Date: | December 21, 2017 |
End Date: | January 2019 |
Contact: | Oleg Khatsenko |
Email: | projectmanager@therapeuticsinc.com |
Phone: | 858-571-1800 |
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
This is a pilot exploratory study to evaluate the safety and efficacy of TC-5214 in subjects
with palmar hyperhidrosis.
with palmar hyperhidrosis.
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.
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