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

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ClinicalTrials.gov Identifier: NCT02973659
Recruitment Status : Completed
First Posted : November 25, 2016
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

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.

Condition or disease Intervention/treatment Phase
Hyperhidrosis Drug: Oxybutynin Drug: Placebos Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Topical Oxybutynin 10% for Treating Primary Focal Hyperhidrosis-axillary, Palmar and Plantar.
Study Start Date : May 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: patients with palmar hyperhidrosis
oxybutynin Vs placebo
Drug: Oxybutynin
10% oxybutynin gel (one side) Vs placebo aqueous gel (other side) - 2/d application, 1 month
Other Name: anti cholinergic

Drug: Placebos
Experimental: patients with plantar hyperhidrosis
oxybutynin Vs placebo
Drug: Oxybutynin
10% oxybutynin gel (one side) Vs placebo aqueous gel (other side) - 2/d application, 1 month
Other Name: anti cholinergic

Drug: Placebos
Experimental: patients with axillary hyperhidrosis
oxybutynin Vs placebo
Drug: Oxybutynin
10% oxybutynin gel (one side) Vs placebo aqueous gel (other side) - 2/d application, 1 month
Other Name: anti cholinergic

Drug: Placebos



Primary Outcome Measures :
  1. The change of Dermatology Life Quality Index (DLQI) [ Time Frame: baseline and following 30 days ]
  2. the chanhe of Hyperhidrosis Disease Severity Scale (HDSS) [ Time Frame: baseline and following 30 days ]

Secondary Outcome Measures :
  1. sweat reduction grading [ Time Frame: 30 days ]
  2. satisfaction rate [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973659


Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Ofir Artzi, MD Dermatology department Tel Aviv medical center

Publications of Results:

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Responsible Party: michal roll, DERMATOLOGIST, HEAD, CENTER OF AESTHETIC DERMATOLOGY, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02973659     History of Changes
Other Study ID Numbers: 0471-14-TLV
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Sweat Gland Diseases
Hyperhidrosis
Skin Diseases
Mandelic Acids
Oxybutynin
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents