- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02973659
The Use of Topical Oxybutynin 10% for Treating Primary Focal Hyperhidrosis-axillary, Palmar and Plantar.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: patients with palmar hyperhidrosis
oxybutynin Vs placebo
|
10% oxybutynin gel (one side) Vs placebo aqueous gel (other side) - 2/d application, 1 month
Other Names:
|
Experimental: patients with plantar hyperhidrosis
oxybutynin Vs placebo
|
10% oxybutynin gel (one side) Vs placebo aqueous gel (other side) - 2/d application, 1 month
Other Names:
|
Experimental: patients with axillary hyperhidrosis
oxybutynin Vs placebo
|
10% oxybutynin gel (one side) Vs placebo aqueous gel (other side) - 2/d application, 1 month
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change of Dermatology Life Quality Index (DLQI)
Time Frame: baseline and following 30 days
|
baseline and following 30 days
|
the chanhe of Hyperhidrosis Disease Severity Scale (HDSS)
Time Frame: baseline and following 30 days
|
baseline and following 30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
sweat reduction grading
Time Frame: 30 days
|
30 days
|
satisfaction rate
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ofir Artzi, MD, Dermatology department Tel Aviv medical center
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Sweat Gland Diseases
- Skin Diseases
- Hyperhidrosis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Oxybutynin
Other Study ID Numbers
- 0471-14-TLV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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