The Use of Topical Oxybutynin 10% for Treating Primary Focal Hyperhidrosis-axillary, Palmar and Plantar.

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary focal hyperhidrosis interferes with daily activities. Limited efficacy, costs, side effects and complications are issues of concern for most current therapeutic modalities. In this study the invetigators aim to evaluate the efficacy of topical oxybutynin 10% gel in treating primary focal hyperhidrosis. 60 patients with primary focal hyperhidrosis will be recruited. Topical oxybutynin 10% gel will be assigned to the right or left axilla, palm or sole and a placebo compound to the contralateral side for a total of 30 days. The Hyperhidrosis Disease Severity Scale (HDSS) and Dermatology Life Quality Index (DLQI) questionnaires will be administered before and after treatment, and 2 noninvolved blinded physicians will score the results using starch-iodine tests. The participants will grade the sweat reduction on both sides and rated their satisfaction.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tel-Aviv Sourasky Medical Center
• Treatments: Mandelic Acids; Oxybutynin

Criteria

Inclusion Criteria:

• healthy individuals

• primary hyperhidrosis (axillary, palmar, plantar) diagnosed according to the recommended criteria4 : focal, visible and excessive sweating of at least 6 months duration without apparent cause, with at least two of the following characteristics: bilateral and symmetric, impairing daily activity, more than one episode per week, onset before age of 25 years, positive family history, cessation during sleep.

• given written informed patient consent of participation in the study

Exclusion Criteria:

• known history of conditions that may cause secondary hyperhidrosis

• eczema, seborrhea, psoriasis

• any other active lesion on treatment site

• any treatment for hyperhidrosis within 4 weeks

• Any medical condition that can be aggravated by anticholinergic medications: glaucoma, micturition disorders, gastric retention, myasthenia gravis, angioedema , known history of Sjögren's syndrome or Sicca syndrome

• iodine allergy

• lactation