Exploratory Study to Assess the Efficacy and Safety of TC-5214 in the Treatment of Subjects With Palmar Hyperhidrosis

• Status: Completed
• Trial end date: 2019-01-18
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Atacama Therapeutics

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.