Botulinum Toxin's Efficacy and Safety for Rosacea Treatment

Danielle Lowe
By Danielle Lowe

Danielle Lowe is the Marketing Manager for, ( the UK’s largest aesthetic information website. 

In the context of treating rosacea, the use of Botulinum Toxin requires further analysis regarding its long-term clinical efficacy and safety says new study.1 While Botulinum Toxin has emerged as a potential treatment option for rosacea in recent times, researchers are urging for more comprehensive and detailed long-term research to better assess its effectiveness.

Despite its recent emergence as a possible therapeutic approach for rosacea patients, a recent systematic review and meta-analysis conducted by investigators highlight the need for more substantial evidence of the long-term clinical efficacy and safety of Botulinum Toxin. The researchers aimed to assess the effectiveness of Botulinum Toxin in treating rosacea in order to offer clinicians a thorough and comprehensive analysis. They point out that although significant improvements in rosacea symptoms have been observed with the use of this emerging treatment, there remains a lack of consensus in the medical community regarding its long-term effects for this particular condition.

The researchers initiated their study by gathering data related to the use of Botulinum Toxin for rosacea treatment, considering studies published up to May 25, 2023. They referred to sources such as China Current Medical Content, the China National Knowledge Infrastructure, the Cochrane Central Register of Controlled Trials in the Cochrane Library, Embase, PubMed, the Wanfang database, and Web of Science. Papers were excluded from consideration if they lacked accessible full texts, were ambiguous, constituted animal experiments, or involved duplicate data. Additionally, guidelines, reviews, abstracts, notes, surveys, and non-peer-reviewed dissertations were ineligible for inclusion. On the other hand, randomised controlled clinical trials, non-randomised controlled trials, prospective or retrospective cohorts, case-control studies, case reports, and case series were all considered eligible.

Following the initial search process, 199 studies, trials, and reports underwent screening and cross-examination of data. Out of these, 109 records were screened, 74 were evaluated for eligibility, and ultimately, 22 studies were included in the analysis.

The forms of rosacea represented in these studies encompassed erythematotelangiectatic rosacea, papulopustular rosacea, unspecified forms of rosacea, and flushing. Notably, all studies involved the application of Botulinum Toxin A, with the majority (n=21) utilising intradermal injection for its administration. Some treatment approaches were supplemented by combining various therapeutic methods, including intense pulsed light, a novel thermomechano-ablative device, pulsed dye laser, supramolecular salicylic acid and hyaluronic acid gel, and an ultrasound impact system.

Across all included studies, efficacy was reported in terms of clinical improvements, reduced disease impact, and overall satisfaction from both patients and clinicians. Commonly reported side effects included minor bruising or mild pain, with these effects being of a mild nature and generally resolving on their own.

Furthermore, studies involving the measurement of Clinician's Erythema Assessment (CEA) scores demonstrated a significant reduction in patient CEA scores one month after Botulinum Toxin treatment compared to baseline, indicating clinical significance in symptom improvement.

However, the review and meta-analysis have certain limitations, including potential bias due to the limited number of relevant randomised controlled clinical trials, inconsistencies in the duration of follow-up visits, and a lack of studies directly comparing treatment efficacy across different skin types.

According to He et al., the authors of the study, "Botulinum toxin is a novel option worth trying in terms of reduction in CEA score, improvement in signs and symptoms, and patient satisfaction. However, this conclusion is limited by the number and quality of research studies available. Larger samples and high-quality RCTs are needed to validate their long-term efficacy and recurrence rates to provide more credible evidence to clinicians. Additionally, there is an incomplete understanding of the prolonged adverse effects of botulinum toxin in patients requiring regular treatment. High costs can also discourage physicians and patients from using it as the preferred treatment modality."

1 - He G, Yang Q, Wu J, et al. Treating rosacea with botulism toxin: Protocol for a systematic review and meta-analysis. J Cos Dermatol. 21 August 2023.

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