Botulinum Toxin Type B for Hidradenitis Suppurativa: A Randomised, Double-Blind, Placebo-Controlled Pilot Study

Øystein Grimstad, Bjørn Øivind Kvammen, Carl Swartling, Øystein Grimstad, Bjørn Øivind Kvammen, Carl Swartling

Abstract

Background: Botulinum toxin (BTX) is a potent neurotoxin with a long history of therapeutic application in neurological and dermatological conditions, with a strong efficacy and safety profile.

Objective: Our aim was to assess whether intradermal injection with BTX-B is an effective treatment for hidradenitis suppurativa (HS).

Methods: Twenty patients with HS stage I-III disease, according to Hurley's classification, were consecutively included for treatment with either a placebo or BTX-B. At the next intervention after 3 months, all participants received the active substance and another follow-up at 6 months. The primary outcome was quality of life, measured using the Dermatology Life Quality Index (DLQI), while secondary outcomes were the visual analogue scale (VAS) for pain in the worst boil and HS-related impairment of general health (VAS), as well as changes in physician-reported disease activity assessed as the number of total lesions, and reported adverse effects of treatment.

Results: The DLQI improved from a median of 17 at baseline to 8 at 3 months in the BTX-B group, compared with a reduction from 13.5 to 11 in the placebo group (p <0.05). Improvement of the patients' own ratings of symptoms and a reduction in total lesions supplemented the primary outcome. Fifty-five percent of the study population reported some degree of hyperhidrosis.

Conclusion: BTX-B improves the quality of life in patients with HS. Furthermore, comorbidity between HS and hyperhidrosis is suggested.

Trial registration: ClinicalTrials.gov identifier: NCT03103074.

Conflict of interest statement

Carl Swartling is a shareholder in Hidros International and is the owner of sweat clinics in Stockholm and Oslo. Øystein Grimstad and Bjørn Øivind Kvammen report no conflicts of interest.

Figures

Fig. 1
Fig. 1
The primary outcome, DLQI, improved from baseline to follow-up at 3 months in the BTX-B group (n =10) compared with placebo (n =10, p <0.05). Change in DLQI with medians (straight line), means (open diamond), outliers (open circle) and spread are shown in the figure. DLQI Dermatology Life Quality Index, BTX-B botulinum toxin B
Fig. 2
Fig. 2
Total number of lesions (nodules, abscesses, fistulas) decreased from baseline in the BTX-B group (filled circle) after first (p <0.01) and second (p <0.01) BTX-B injections. In the placebo group (filled square), a slight decrease of lesions was seen at 3 months (not statistically significant), but, in an open setting, a clear decrease from baseline was seen at 6 months when BTX-B was administered (p <0.05). BTX-B botulinum toxin B

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