The Use of Topical Oxybutynin 10% for Treating Primary Focal Hyperhidrosis-axillary, Palmar and Plantar.
Primary Purpose
Hyperhidrosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oxybutynin
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhidrosis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
patients with palmar hyperhidrosis
patients with plantar hyperhidrosis
patients with axillary hyperhidrosis
Arm Description
oxybutynin Vs placebo
oxybutynin Vs placebo
oxybutynin Vs placebo
Outcomes
Primary Outcome Measures
The change of Dermatology Life Quality Index (DLQI)
the chanhe of Hyperhidrosis Disease Severity Scale (HDSS)
Secondary Outcome Measures
sweat reduction grading
satisfaction rate
Full Information
NCT ID
NCT02973659
First Posted
November 6, 2016
Last Updated
November 23, 2016
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02973659
Brief Title
The Use of Topical Oxybutynin 10% for Treating Primary Focal Hyperhidrosis-axillary, Palmar and Plantar.
Official Title
The Use of Topical Oxybutynin 10% for Treating Primary Focal Hyperhidrosis-axillary, Palmar and Plantar.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This study will be performed at the Tel Aviv Medical Center. Written informed consent will be obtained from all 60 participants prior to entering the study. patients with primary focal hyperhidrosis (palmar hyperhidrosis, axillary hyperhidrosis, plantar hyperhidrosis) who receive no topical or oral anticholinergics, iontophoresis treatment or botulinum toxin injections during the 6 months prior to study entry and did not undergone sympathectomy will be recruited. Demographic data, including gender, age and medical history will be collected before enrollment in the study, and the following patients will be excluded: pregnant or lactating women, individuals with conditions that may cause secondary hyperhidrosis, individuals with a history of eczema, seborrhea, psoriasis, glaucoma, micturition disorder, gastric retention, myasthenia gravis, angioedema, Sjögren's syndrome, or Sicca syndrome, and candidates older than 60 years or younger than 18 years.
The study will follow a prospective, randomized, double blind, placebo-controlled design. Each participant will be given a pair of test jars (designated as "'gel A"' and "'gel B"'). The investigators will use a designated software to randomize the jars (either A or B) which contained 10% oxybutynin gel or a placebo aqueous gel. The two jars are identical in shape, size and weight, as well as color, odor and consistency. The patients will be instructed to apply 1 cm of gel A or B on clean, dry and intact skin of one sweating area (right or left palms, soles or axillae) twice daily for 30 days. In addition, the participants will be instructed to avoid contact of the gel with the eyes, nose, mouth, and not to wash the areas for 4 hours post-application. The participants will be also instructed not to use any concomitant topical or systemic medication during the entire treatment period. Each jar will be weighed by a digital scale before treatment initiation and on the 30th day of treatment.
The participants will interviewed twice, first at the time of screening before the initial application and then following the completion of the 30th day of treatment. The participants will be asked to rate the severity of their condition using the hyperhidrosis disease severity scale in which a score of 3 or 4 indicates severe hyperhidrosis while a score of 1 or 2 indicates mild or moderate hyperhidrosis. The therapeutic results will be considered as "excellent" or "good" if the patient indicate a reduction of 2 or 1 points, respectively, on the HDSS score.
In addition, quality of life will be assessed by a modified Dermatology Life Quality Index. The maximum score is 30, with 0 indicating a negligible effect of the disorder on the patient's quality of life and 30 indicating a significant impact. A change of 0-1 point on the mDLQI score will be interpreted as reflecting no effect on the patient's life, a change of 2-5 points as a small effect, 6-10 points as a moderate effect, 11-20 points as a very significant modification, and 21-30 points as the most significant impact possible.
At the end of the treatment, patients will complete a questionnaire evaluating the following:
Sweat reduction in the treated and in the control sweating areas (0 = no change, 1 = poor (limited improvement with the patient being very much aware of sweating), 2 = fair (marked improvement, with noticeable sweating under stressful conditions only, 3 = good (marked improvement with minimal sweating under stressful conditions), and 4 = excellent improvement, with cessation of sweating)
Global patient satisfaction (0 = dissatisfied, 1 = partially satisfied, 2 = satisfied, and 3 = highly satisfied).
Side effects: dry mouth, headache, dizziness, urine retention, constipation and application site reactions (pruritus or dermatitis).
All patients will undergo the Minor iodine-starch test. The tested area will be photographed under standard conditions using the Galaxy Camera (3G) EK-GC100 photography system. Photographs taken before and after 30 days of treatment will be independently assessed by two dermatologists who are unaware of the study design. All pairs of photographs will be graded as 0 = no change, 1 = minor change of <25%, 2 = moderate change between 25-50%, 3 = major change between 50-75%, and 4 = absence or near absence of sweating.
Both the study and control gels will be compounded in an Israeli compounding pharmacy.
Continuous variables will be fed into a tabular format as means ± standard errors and compared using the Wilcoxon paired test. Categorical variables will be tested using the Fisher exact test. Correlation between raters will evaluated using Spearman's correlation. All analyses were carried out using SPSS 23.0.2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients with palmar hyperhidrosis
Arm Type
Experimental
Arm Description
oxybutynin Vs placebo
Arm Title
patients with plantar hyperhidrosis
Arm Type
Experimental
Arm Description
oxybutynin Vs placebo
Arm Title
patients with axillary hyperhidrosis
Arm Type
Experimental
Arm Description
oxybutynin Vs placebo
Intervention Type
Drug
Intervention Name(s)
Oxybutynin
Other Intervention Name(s)
anti cholinergic
Intervention Description
10% oxybutynin gel (one side) Vs placebo aqueous gel (other side) - 2/d application, 1 month
Intervention Type
Drug
Intervention Name(s)
Placebos
Primary Outcome Measure Information:
Title
The change of Dermatology Life Quality Index (DLQI)
Time Frame
baseline and following 30 days
Title
the chanhe of Hyperhidrosis Disease Severity Scale (HDSS)
Time Frame
baseline and following 30 days
Secondary Outcome Measure Information:
Title
sweat reduction grading
Time Frame
30 days
Title
satisfaction rate
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ofir Artzi, MD
Organizational Affiliation
Dermatology department Tel Aviv medical center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26114588
Citation
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.
Results Reference
result
PubMed Identifier
22341836
Citation
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.
Results Reference
result
PubMed Identifier
23167161
Citation
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.
Results Reference
result
PubMed Identifier
20626389
Citation
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.
Results Reference
result
PubMed Identifier
21963104
Citation
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.
Results Reference
result
PubMed Identifier
19233423
Citation
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.
Results Reference
result
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The Use of Topical Oxybutynin 10% for Treating Primary Focal Hyperhidrosis-axillary, Palmar and Plantar.
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