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Randomized Controlled Trial
. 2025 Apr 1;317(1):661.
doi: 10.1007/s00403-025-04069-2.

The comparative study of letibotulinum toxin A and onabotulinum toxin A in treatment of primary axillary hyperhidrosis

Sunatra Nitayavardhana  1 , Romun Leaovitavat  2
Affiliations
Randomized Controlled Trial

The comparative study of letibotulinum toxin A and onabotulinum toxin A in treatment of primary axillary hyperhidrosis

Sunatra Nitayavardhana et al. Arch Dermatol Res. .

Abstract

Primary axillary hyperhidrosis (PAH) is a challenging condition characterized by excessive underarm sweating. The U.S. Food and Drug Administration has approved onabotulinum toxin A (OnaBTX-A, Botox®, Allergan Inc, USA) as the only botulinum toxin treatment for severe axillary hyperhidrosis, and it has demonstrated positive results. Recently, the off-label use of letibotulinum toxin A (LetiBTX-A, Hugel®, Hugel Inc, Korea) has risen significantly for cosmetic purposes due to its effectiveness. For the treatment of primary axillary hyperhidrosis, the authors proposed that LetiBTX-A is at least as effective as OnaBTX-A. To evaluate the efficacy and safety of letibotulinum toxin A (LetiBTX-A) in comparison to onabotulinum toxin A (OnaBTX-A) for treating primary axillary hyperhidrosis (PAH). All participants with a diagnosis of moderate to severe primary axillary hyperhidrosis (Hyperhidrosis Disease Severity Scale (HDSS) score ≥ 2) received random injections of 50 U of LetiBTX-A in one armpit and 50 U of OnaBTX-A in the other site. HDSS score and hyperhidrosis area were measured by using the Minor's iodine starch test. Participant satisfaction was evaluated at 1, 3, and 6 months following the injection. Onset of action and adverse events were also assessed. All 30 participants completed the study protocol, with the mean age was 34.44 ± 7.82 years and most of the participants were female. The mean age at onset was 20.47 ± 3.01 years and more than 50% of participants had a HDSS score of 3. There was no statistically significant difference observed in the reduction of HDSS scores, hyperhidrosis area, and participant satisfaction between the axillae treated with LetiBTX-A and those treated with OnaBTX-A at 1, 3 and 6 months after injections. The median onset of action of both LetiBTX-A and OnaBTX-A were 2 ± 1 day (p = 0.317). Procedure-related pain was comparable between 2 formulations (P = 0.876). No serious adverse event was observed. This study concluded that LetiBTX-A and OnaBTX-A demonstrate comparable efficacy and safety profiles in treating primary axillary hyperhidrosis (PAH).

Keywords: Botulinum toxin type A; Hyperhidrosis; Letibotulinum toxin A; Onabotulinum toxin A.

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Conflict of interest statement

Declarations. Competing interests: The authors declare no competing interests.

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