The Use of Topical Oxybutynin 10% for Treating Primary Focal Hyperhidrosis-axillary, Palmar and Plantar.
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional

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:

        1. 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)

        2. Global patient satisfaction (0 = dissatisfied, 1 = partially satisfied, 2 = satisfied,
           and 3 = highly satisfied).

        3. 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.
    

Intervention name(s): Oxybutynin; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 10% oxybutynin gel (one side) Vs placebo aqueous gel (other side) - 2/d application, 1 month
Other intervention name(s): anti cholinergic
Intervention MeSH terms: Oxybutynin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment