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

NCT02973659 | Completed

• 1 other identifier: 0471-14-TLV
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hyperhidrosis

Outcome Measures

Primary Outcomes (2)

• The change of Dermatology Life Quality Index (DLQI)

  baseline and following 30 days

• the chanhe of Hyperhidrosis Disease Severity Scale (HDSS)

  baseline and following 30 days

Secondary Outcomes (2)

• sweat reduction grading

  30 days

• satisfaction rate

  30 days

Study Arms (3)

patients with palmar hyperhidrosis

EXPERIMENTAL

oxybutynin Vs placebo

Drug: Oxybutynin; Drug: Placebos

patients with plantar hyperhidrosis

EXPERIMENTAL

oxybutynin Vs placebo

Drug: Oxybutynin; Drug: Placebos

patients with axillary hyperhidrosis

EXPERIMENTAL

oxybutynin Vs placebo

Drug: Oxybutynin; Drug: Placebos

Interventions

Oxybutynin DRUG

10% oxybutynin gel (one side) Vs placebo aqueous gel (other side) - 2/d application, 1 month

Also known as: anti cholinergic

patients with axillary hyperhidrosis; patients with palmar hyperhidrosis; patients with plantar hyperhidrosis

Placebos DRUG

patients with axillary hyperhidrosis; patients with palmar hyperhidrosis; patients with plantar hyperhidrosis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Related Publications (6)

• Schollhammer M, Brenaut E, Menard-Andivot N, Pillette-Delarue M, Zagnoli A, Chassain-Le Lay M, Sassolas B, Jouan N, Le Ru Y, Abasq-Thomas C, Greco M, Penven K, Roguedas-Contios AM, Dupre-Goetghebeur D, Gouedard C, Misery L, Le Gal G. Oxybutynin as a treatment for generalized hyperhidrosis: a randomized, placebo-controlled trial. Br J Dermatol. 2015 Nov;173(5):1163-8. doi: 10.1111/bjd.13973. Epub 2015 Oct 14.

  PMID: 26114588 RESULT

• Wolosker N, de Campos JR, Kauffman P, Puech-Leao P. A randomized placebo-controlled trial of oxybutynin for the initial treatment of palmar and axillary hyperhidrosis. J Vasc Surg. 2012 Jun;55(6):1696-700. doi: 10.1016/j.jvs.2011.12.039. Epub 2012 Feb 16.

  PMID: 22341836 RESULT

• Try C, Messikh R, Elkhyat A, Aubin F, Humbert RP. [Use of oral oxybutynin at 7.5 mg per day in primary hyperhidrosis]. Rev Med Liege. 2012 Oct;67(10):520-6. French.

  PMID: 23167161 RESULT

• Cartwright R, Srikrishna S, Cardozo L, Robinson D. Patient-selected goals in overactive bladder: a placebo controlled randomized double-blind trial of transdermal oxybutynin for the treatment of urgency and urge incontinence. BJU Int. 2011 Jan;107(1):70-6. doi: 10.1111/j.1464-410X.2010.09508.x.

  PMID: 20626389 RESULT

• Sand PK, Davila GW, Lucente VR, Thomas H, Caramelli KE, Hoel G. Efficacy and safety of oxybutynin chloride topical gel for women with overactive bladder syndrome. Am J Obstet Gynecol. 2012 Feb;206(2):168.e1-6. doi: 10.1016/j.ajog.2011.08.005. Epub 2011 Aug 11.

  PMID: 21963104 RESULT

• Staskin DR, Dmochowski RR, Sand PK, Macdiarmid SA, Caramelli KE, Thomas H, Hoel G. Efficacy and safety of oxybutynin chloride topical gel for overactive bladder: a randomized, double-blind, placebo controlled, multicenter study. J Urol. 2009 Apr;181(4):1764-72. doi: 10.1016/j.juro.2008.11.125. Epub 2009 Feb 23.

  PMID: 19233423 RESULT

MeSH Terms

Conditions

Hyperhidrosis

Interventions

oxybutynin; Cholinergic Antagonists

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Ofir Artzi, MD

  Dermatology department Tel Aviv medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DERMATOLOGIST, HEAD, CENTER OF AESTHETIC DERMATOLOGY

Study Record Dates

• First Submitted: November 6, 2016
• First Posted: November 25, 2016
• Study Start: May 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 25, 2016

Record last verified: 2016-11