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Botulinum Toxin-loaded Detachable Dissolvable Microneedles for Primary Axillary Hyperhidrosis: A Pilot Study on
Jidapa Triwatcharikorn1, Kridipop Charoenchaipiyakul1, Titiporn Sansureerungsikul2
1Drs. Triwatcharikorn, Charoenchaipiyakul, Chuenboonngarm, Kantikosum, Chottawornsak, Chancheewa, Puaratanaarunkon, Panchaprateep, Kumtornrut, and Asawanonda are affiliated with the Division of Dermatology, Department of Medicine, Faculty of Medicine at Chulalongkorn University in Bangkok, Thailand.
Objective:
Botulinum toxin injection is a well-established treatment for primary hyperhidrosis. The botulinum toxin-loaded detachable dissolvable microneedles (BoNT-MNs) were developed in a result of disadvantages of the intradermal procedure. This pilot study aims to evaluate the efficacy and safety of BoNT-MNs.
Methods:
This within-subject study included ten adults (N=10; 100% female) with mild primary axillary hyperhidrosis. BoNT-MNs patches were prepared and each microneedle patch contained 15 units of onabotulinum toxin. BoNT-MNs and placebo patches were randomly applied to different sides of axilla. Iodine-starch test, dermatologists' and patients' satisfaction scores were assessed at baseline and Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
Results:
All ten female subjects completed the trial. Notably, on the BoNT-MNs side, iodine starch scores exhibited an onset at Week 2, with a 57.14-percent reduction at Week 12, returning to baseline after Week 20. Dermatologists' and patients' satisfaction scores were consistently superior to the placebo side from Week 2 and Week 1, respectively, until Week 16, with statistical significance (p<0.05) observed at Week 12 and Week 2.
Limitations:
This study involved a limited number of female participants and administered a single, small dosage of botulinum toxin in the BoNT-MNs.
Conclusions:
Botulinum toxin-loaded detachable dissolvable microneedles patches offer a safe and effective method for reducing axillary sweating.
Clinical Trial:
This study was approved by the Institutional Review Board of Faculty of Medicine, Chulalongkorn University with IRB number 567/63, and registered in the Thai Clinical Trials Registry (Thaiclinicaltrials.org) under registration number TCTR20201230002.
