Category: Botox

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

Arch Dermatol Res. 2025 Apr 1;317(1):661. doi: 10.1007/s00403-025-04069-2.

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).

PMID:40167830 | DOI:10.1007/s00403-025-04069-2

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Reconstituted and frozen botulinum toxin A is as effective and safe as fresh for treating axillary hyperhidrosis: A retrospective study

PLoS One. 2023 Dec 4;18(12):e0295393. doi: 10.1371/journal.pone.0295393. eCollection 2023.

ABSTRACT

The use of reconstituted and frozen left-over botulinum toxin A, for treatment of patients with axillary hyperhidrosis seems to be common practice in healthcare. Thus, the objective of this study was to investigate the efficacy and safety of frozen and thawed versus fresh reconstituted abobotulinum toxin (Dysport®) and onabotulinum toxin (Botox®) in the treatment of axillary hyperhidrosis. A retrospective study was conducted analysing efficacy and data from pre- and 24 weeks post-treatment questionnaires together with medical records of individuals with moderate to severe axillary hyperhidrosis. The patients had received fresh prepared botulinum toxin A in their right axilla while frozen and thawed botulinum toxin A had been administered in their left axilla. Treatment was conducted at our Hyperhidrosis Clinic, Umeå University Hospital, Sweden 2019-2021. Pre- and post-treatment questionnaires from 106 patients were analysed. The patients were 18 to 55 years old, with a mean age of 30.7 ± 9.9 years. No significant differences in patient-reported variables, Hyperhidrosis Disease Severity Scale and VAS 10-point scale, were found between the different preparations (frozen compared to fresh) for abobotulinum toxin and onabotulinum toxin, before treatment and at 6 months follow-up. Multivariable regression analysis resulted in no significant difference regarding side-effects between the preparations or brands of botulinum toxin. The findings of this study support our clinical experience that both abobotulinum toxin and onabotulinum toxin, reconstituted, frozen and thawed, seem to be as effective and safe as fresh prepared botulinum toxin when treating axillary hyperhidrosis. Our findings indicate that left-over preparations of abo- and onabotulinum toxins, stored and frozen for up to 6 months, is a cost-and time-effective way of handling botulinum toxin for treatment of axillary hyperhidrosis.

PMID:38048338 | DOI:10.1371/journal.pone.0295393

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Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact

Medicine (Baltimore). 2023 Jul 1;102(S1):e32764. doi: 10.1097/MD.0000000000032764.

ABSTRACT

Hyperhidrosis (chronic excessive sweating) may substantially affect an individual’s emotional and social well-being. Therapies available before onabotulinumtoxinA were generally topical, with limited effectiveness, application-site skin reactions, and frequent, time-consuming treatments. Intradermal injection of onabotulinumtoxinA to treat sweat glands arose as a novel therapeutic approach. To develop this treatment, appropriate dosing needed to be established, and training on administration was required. Further, no previous scale existed to measure the effects of hyperhidrosis on patients’ lives, leading Allergan to develop and validate the 4-point Hyperhidrosis Disease Severity Scale (HDSS), which measures the disease’s impact on daily activities. The onabotulinumtoxinA clinical development program for hyperhidrosis included 2 double-blind, placebo-controlled pivotal trials, immunogenicity studies, long-term studies of safety and efficacy, and quality of life assessments. In Europe and North America, the primary efficacy measures were, respectively, axillary sweat production measured gravimetrically and HDSS improvement. Compared with placebo, onabotulinumtoxinA treatment significantly reduced axillary sweat production and axillary hyperhidrosis severity, as measured by a 2-point or greater reduction on the HDSS. The effects of onabotulinumtoxinA occurred rapidly, within 1 week after injection, and lasted ≥6 months. Treatment with onabotulinumtoxinA was associated with significant quality of life improvements based on Short Form-12 physical and mental component scores. The Hyperhidrosis Impact Questionnaire also indicated greater treatment satisfaction, reduced negative impact on aspects of daily life, and improved emotional well-being with onabotulinumtoxinA versus placebo. The clinical development program and subsequent clinical experience showed that onabotulinumtoxinA treatment for hyperhidrosis was well tolerated with no new safety signals, and led to greater disease awareness.

PMID:37499084 | DOI:10.1097/MD.0000000000032764

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Five-year follow-up of patients treated with intra-dermal botulinum toxin for axillary hyperhidrosis.

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Five-year follow-up of patients treated with intra-dermal botulinum toxin for axillary hyperhidrosis.

Ir J Med Sci. 2020 Jan 03;:

Authors: Lynch OE, Aherne T, Gibbons J, Boland MR, Ryan ÉJ, Boyle E, Egan B, Tierney S

Abstract
BACKGROUND: Axillary hyperhidrosis is a common complaint affecting 5% of the general population. It can significantly impact quality of life (QOL) and may be extremely debilitating. Administration of intra-dermal botulinum toxin type-A (Botox) has been proven to be effective in managing axillary hyperhidrosis; however, to date, no long-term data has assessed its efficacy.
AIM: We aim to assess long-term (> 5 years) QOL outcomes in this patient cohort.
METHODS: In this single-centre series, all patients attending for axillary botox, with five or more years of follow-up, were prospectively included. QOL was assessed in all patients using the validated assessment tool, the modified Dermatology Life Quality Index (DLQI). Standard statistical methods were utilised with data reported as mean (± standard deviation). Subgroup analysis utilising previously published departmental data allowed for further assessment of change in QOL over time.
RESULTS: A total of 75 patients (83% female) met the inclusion criteria with 67% completing the DLQI assessment. Follow-up ranged from 5 to 10 years with a mean age of 37.6 years (± 8.82). The mean number of treatments over the study period was 12 (± 3.1). Mean overall post-treatment DLQI score was 1.6 (± 2.01). This represented a significant improvement in patient QOL (p = < 0.0001) associated with long-term botox application. This statistical significance was identified consistently across all components of the DLQI tool.
CONCLUSION: These data suggest that the established early QOL benefits associated with intra-dermal botox administration for AH are sustained in the long term. This benefit was seen across all subsets of the DLQI tool.

PMID: 31898163 [PubMed – as supplied by publisher]