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

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: