DOI: 10.14457/tu.the.2016.551
title: Efficacy of topical botulinum toxin type A cream for treatment of primary axillary hyperhidrosis: a randomized, double-blinded, split site, vehicle control study

description: Background: The treatment of Primary Axillary Hyperhidrosis (PAH) with traditional needle-based botulinum toxin delivery has been proven to be effective with Botulinum Toxin Type A (BTX-A). However, it is mainly associated with more pains and costs, as well as a number of adverse events following the injections, such as pains, redness at injection site, and possible muscle weakness. In a recent study, the effectiveness of topical BTX-A was significantly shown in PAH treatment with a decreased risk of side effects, resulting in no systemic and very few local adverse events. Therefore, this research is created for the purpose of testing the efficacy of low dose topical liposomal based BTX-A cream as a novel and cost-effective modality for treatment of PAH. Ultimately, this non-invasive topical method could yield treatment efficacy for PAH with minimally effective concentration of BTX-A.Objective: This research has been created in order to test the efficacy and safety of BTX-A in multilamellar liposomal beaded capsule cream for treatment of PAH compared to vehicle cream.Methods: A prospective, randomized, double blinded, split site study was conducted in participants, aged &gt; 18 years, having symmetrical sweating with hyperhidrosis severity scale (HDSS) of 2-4. The amount of sweat reduction was assessed using a Tewameter. BTX-A (30U), combined with multilamellar liposomal based cream to bind the toxin, was applied to one axilla and the vehicle without BTX-A to the other axilla once daily before bedtime with a total duration of seven days. Clinical improvement was evaluated using Tewameter, Minor’s Iodine Starch Test, HDSS, and Dermatology Life Quality Index (DLQI) every 2-week visit until 8 weeks. The data from questionnaires of patients’ satisfaction and adverse reactions were recorded at every follow- up visit.Results: Twenty participants, with mean (SD) age of 37.55 (9.41), were recruited into the study. Of these, 80% and 20% were female and male, respectively. At the 2nd, 4th, 6th and 8th week of follow-up, the topical BTX-A treated side demonstrated sweat reduction of 8.06, 6.47, 7.15 and 3.94, respectively with mean difference from Tewameter measurement relative to the same-patients in the vehicle-control treated axillae, with statistical significance (p&lt;0.001). Also, clinical grading by panel assessment of IST photography showed statistically significant (p&lt;0.001) improvement with mean difference of 1.50, 1.50, 1.10 and 0.75 at the 2nd, 4th, 6th, and 8th weeks of follow-up, respectively. According to the statistic result, HDSS score shows a great difference between the BTX-A treated and the vehicle treated groups (p&lt;0.001). As well, DLQI score showed the improvement in 8 from 10 choices, with statistical significance (p&lt;0.05). Nonetheless, no side effects were present in this study.Conclusion: The results of the 30U of BTX-A inversion with multilamellar liposomal beaded capsule cream could provide effective treatment outcomes of PAH compared to the vehicle control treated side, evaluated by Tewameter. The clinical grading of improvement was noted by Minor’s Iodine Starch Test (IST), HDSS, and DLQI. Tewameter demonstrated the statistically significant improvement of the BTX-A treated side compared with the vehicle control treated side. Meanwhile, HDSS score showed improvement in the BTX-A treated group compared to the control treated group, with statistical significance (p&lt;0.001). Moreover, DLQI illustrated the significantly improved quality of life and greater patient’s satisfaction outcomes with no serious side effects. Hence, the topical BTX-A could be an innovative painless and cost effective treatment of PAH.