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Injection of botulinum toxin into each splenius capitis muscle at baseline and week 12 was more effective than placebo in reducing the severity of essential head tremor over 18 weeks. Effects waned at 24 weeks.

The present study aimed to assess the effectiveness and functional adverse effects of a single and multiple injections of botulinum toxin A (BoNT-A) for masseter hypertrophy (MH). Twenty-six women complaining about lower third facial enlargement due to MH, received 75 U of BoNT-A (abobotulinum toxin) in each masseter muscles. After 3 months, patients were randomly assigned to receive a second treatment session of Saline Solution: (G1; n = 11) or BoNT-A: (G2; n = 12). Muscle thickness (ultrasound), electrical activity (electromyography; EMG), masticatory performance, and subjective perception of MH were evaluated. Follow-up was performed at 1, 3 and 6 months. Muscle thickness, EMG activity, and masticatory performance were analyzed using ANOVA two-way and Sidak test as post-hoc. Masticatory performance was analyzed by the Friedman’s test and Mann–Whitney test. Regarding inter-groups comparisons, there was a significant decrease in the left masseter muscle thickness in the G2 group at the 6 month follow-up (p < 0.02). For EMG, significant differences were evident at the 6 month assessment, with higher masseter activity for G1 (p < 0.05). For masticatory performance, no significant differences were observed throughout the study (p > 0.05) and a higher improvement in subjective perception of MH was observed in the 1 month follow-up for G2 (p < 0.05). In conclusion, BoNT-A is effective for MH, however multiple injections cause functional adverse effects in masseter muscle.

The aim of the study was to assess safety and efficacy of botulinum-A toxin (BTX) injection into the bulbospongiosus muscle versus hyaluronic acid (HA) gel injection in glans penis for treatment of premature ejaculation (PE). The patients were randomly divided into 2 groups. Group a (n = 30) were injected with botulinum toxin type a injection in bulbospongiosus (BS) muscle at the perineum (25 units on each side). Group b (n = 30) were injected with 2 ml hyaluronic acid along the corona (proximal part) of the glans penis and frenulum. The mean IELT significantly increased from 1.78 min to 3.87 min after the BTX injection while the mean IELT was significantly increased to 7.3 min from 1.23 min before injection among the hyaluronic acid injected group (p < 0.001). The improvement of IELT was more significantly noted in the HA group than BTX group by the end of treatment. Both modalities provided a well- tolerated potential treatment in the management of PE with, HA demonstrating a higher efficacy than BTX. More high-quality, randomized prospective studies and the standardization of the inclusion criteria and the outcome assessment methods are needed in order to confirm these findings.

Previous randomized controlled trials (RCTs) investigating Botulinum toxin A (BoNT-A) for treatment of hemifacial spasm (HFS) have primarily focused on symptom relief and quality-of-life improvement. However, head-to-head comparisons of different BoNT-A formulations, particularly in terms of onset, duration of action, and efficacy, remain limited. We conducted a 12-week prospective, randomized controlled trial comparing the efficacy and safety of 33.33 units of Neubotulinum toxin A (Neu-BoNT-A) with 100 units of Abobotulinum toxin A (Abo-BoNT-A) in the treatment of HFS. A total of 87 patients were enrolled between September and December 2024. Neu-BoNT-A and Abo-BoNT-A exhibited similar onset and duration of action [5.0 ± 0.9 vs. 6.2 ± 0.7 days, respectively (p = 0.33)]. After 12 weeks of treatment, Neu-BoNT-A demonstrated superior efficacy in reducing the daily duration of HFS (2.00 ± 0.06 vs. 1.42 ± 0.10 h/day, p < 0.001) and improving sleep duration (1.37 ± 0.01 vs. 1.06 ± 0.01 h/day, p < 0.001). However, Abo-BoNT-A was associated with significantly lower absolute daily disability time compared to Neu-BoNT-A (11.4 vs. 1.2 min/day, p < 0.001). No serious adverse events were observed. Both Neu-BoNT-A and Abo-BoNT-A were safe and effective in treating HFS. However, Neu-BoNT-A was more effective in HFS with minimal symptoms without disability and Abo-BoNT-A more effective in HFS with greater duration of disability.

Background: Melasma is an acquired hyperpigmentation disorder with multifactorial etiologies and limited response to conventional therapies. Recent evidence suggests that Botulinum Toxin A (BoNT-A) may modulate ultraviolet (UV)-induced pigmentation and offer therapeutic benefits. Objective: We sought to evaluate the efficacy and safety of two intradermal dilutions of Letibotulinum toxin A (LetiBoNT-A) in Thai patients with melasma. Methods: In this randomized, double-blind, split-face study, 30 participants aged 32–62 years received a single intradermal injection of LetiBoNT-A, with 20 units administered per cheek. A 1:5 dilution was injected on one side of the face, and a 1:10 dilution was injected on the contralateral side. Outcomes were evaluated over a 6-month period using the Hemi-modified Melasma Area and Severity Index (Hemi-mMASI), VISIA® brown spot analysis, and quantitative assessments of skin texture. Results: Both dilutions significantly improved Hemi-mMASI scores (1:5, p = 0.043; 1:10, p = 0.002) and brown spots (1:5, p = 0.002; 1:10, p < 0.001). The 1:10 dilution showed earlier and more sustained improvements. Subgroup analysis revealed greater reductions in Hemi-mMASI scores among patients with telangiectatic melasma, particularly with the 1:10 dilution, though they were not statistically significant. Additionally, the 1:10 dilution significantly reduced pore volume, pore area, and sebum levels. One case of transient facial asymmetry was reported with the 1:5 dilution. Conclusions: LetiBoNT-A is a safe and effective adjunct in melasma treatment. The 1:10 dilution offered superior clinical outcomes.

To evaluate the therapeutic effect of combining subconjunctival botulinum toxin A (BTX-A) with periorbital triamcinolone acetonide (TA) injections in treating upper eyelid retraction (UER) due to thyroid-associated ophthalmopathy (TAO). Fifty eyes with TAO-related UER were randomized into two groups. Group 1 received TA alone, while group 2 received BTX-A plus TA. Marginal reflex distance (MRD1) and graine sign (GS) were measured at baseline and post-injection intervals. Elevated intraocular pressure incidence was monitored. Group 1 showed significant MRD1 reductions at 1, 3, and 6 months ( P  < 0.05) and a GS increase at 3 months ( P  < 0.05). Group 2 exhibited quicker MRD1 reductions at 1 week, 1, 3, and 6 months ( P  < 0.05) and earlier GS improvements at 1 week, 1, and 3 months ( P  < 0.05). Group 2 had lower MRD1 and higher GS values one week post-initial injection ( P  < 0.001 and P  = 0.013, respectively) and a lower incidence of elevated intraocular pressure compared to group 1 ( P  < 0.05). In a six-month study, patients treated with BTX-A and TA for TAO-related UER experienced a faster therapeutic onset and sustained efficacy with reduce the total dose of multiple local TA injections and fewer side effects like elevated intraocular pressure.The trial registration number is ChiCTR2300077958, with the date of registration being 24/11/2023 (retrospectively registered).

Data from previous studies suggest that botulinum toxin A has analgesic effects against peripheral neuropathic pain, but the quality of the evidence is low. We aimed to assess the safety and efficacy of repeated administrations of botulinum toxin A in patients with neuropathic pain. We did a randomised, double-blind, placebo-controlled trial at two outpatient clinics in France (Clinical Pain Centre, Ambroise Paré Hospital, APHP, Boulogne-Billancourt, and Neurological Centre, Hôpital Dupuytren, Limoges) and one in Brazil (Neurological Department, Hospital das Clínicas da FMUSP, São Paulo). Patients aged 18–85 years with peripheral neuropathic pain were randomly assigned (1:1) by block randomisation, according to a centralised schedule, to receive two subcutaneous administrations of botulinum toxin A (up to 300 units) or placebo, 12 weeks apart. All patients and investigators were masked to treatment assignment. The primary outcome was the efficacy of botulinum toxin A versus placebo, measured as the change from baseline in self-reported mean weekly pain intensity over the course of 24 weeks from the first administration. The primary efficacy analysis was a mixed-model repeated-measures analysis in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT01251211. Between Oct 2, 2010, and Aug 2, 2013, 152 patients were enrolled, of whom 68 were randomly assigned (34 per group), and 66 (37 [56%] men) were included in the primary analysis (34 in the botulinum toxin A group and 32 in the placebo group). Botulinum toxin A reduced pain intensity over 24 weeks compared with placebo (adjusted effect estimate −0·77, 95% CI −0·95 to −0·59; p<0·0001). Pain on injection was the only adverse effect reported, and occurred in 19 (56%) participants in the botulinum toxin A group and 17 (53%) of those in the placebo group (p=1·0). Severe pain was experienced by ten (29%) participants in the botulinum toxin A group and 11 (34%) in the placebo group (p=0·8). Two administrations of botulinum toxin A, each of which comprised several injections, have a sustained analgesic effect against peripheral neuropathic pain. Several factors, such as the presence of allodynia and a limited thermal deficit, may be useful in predicting treatment response and should be investigated further. Institut National de la Santé et de la Recherche Médicale (INSERM) and Fondation CNP (France).

To evaluate the efficacy and safety of pulsed dye laser (PDL) alone, the combination of PDL and botulinum toxin type A (BTA) injection, and the combination of PDL and triamcinolone injection in the treatment of hypertrophic scars and keloids. In this three-arm, single-blind randomized controlled clinical trial, 10 patients over 18 years old with hypertrophic scars or keloids were enrolled. Each patient had at least 3 lesions, each measuring at least 10 × 10 square centimeters or 10 centimeters long. In the first treatment session, each of the 3 lesions was randomly assigned to one of three interventions: PDL (control), PDL with BTA injection (at a concentration of 2 units/cm 2 ), or PDL with triamcinolone injection (20 mg/cc). All the interventions carried out in the groups have been repeated in three sessions. One follow-up visit took place one month after the last session, without any intervention. Clinical images of the lesions were collected during the treatment sessions. A blinded dermatologist assessed the effectiveness of the treatment using a physician global assessment score and the Vancouver Scar Scale (VSS). Patient satisfaction and any side effects were recorded during follow-up visits. The average age of the cases under consideration was 36.00 ± 13.23 years. In terms of gender, 4 out of the cases (40.00%) were females. During the initial session, the mean VSS scores in the PDL, PDL–BTA, and PDL–Triamcinolone groups were 7.90 ± 1.52, 7.10 ± 0.56, and 7.30 ± 0.24, subsequently. These scores decreased to 7.30 ± 1.34, 4.90 ± 1.37, and 4.30 ± 0.95 in the PDL, PDL–BTA, and PDL–Triamcinolone groups, respectively ( P  = 0.001). The group that received both PDL and BTA showed the most significant enhancement in pliability ( P  = 0.001) and regarding scar vascularity and height the most improvement was related to PDL-triamcinolone group ( P  = 0.01 and 0.001, respectively). In addition, the level of physician’s satisfaction in the PDL–BTA and PDL–Triamcinolone groups were significantly higher than in the PDL group ( P  = 0.004). However, no significant difference was seen between the combined treatments. Finally, no significant side effects were observed in the studied methods during various treatment sessions. The findings of the study revealed that utilizing a combination of two modalities yielded better outcomes compared to a single treatment approach. Specifically, the combination of PDL and BTA demonstrated greater improvement in scar pliability. On the other hand, when considering scar vascularity and height, the combination of PDL with triamcinolone exhibited more significant enhancement. What’s already known about this topic? • Hypertrophic and keloid scars are often characterized by unsightly appearances and impose numerous restrictions on patients. Various treatments have been suggested for these skin lesions, each associated with different levels of effectiveness in promoting recovery. • The pulsed dye laser is an effective treatment option for vascular lesions, hypertrophic scars, and keloids. It is associated with improvements in color, reduction in height, and increased flexibility. What does this study add? • The combined treatment of PDL and BTA (at a dose of 2 units per square centimeters) is an effective option for treating hypertrophic scars and keloids. This combination is more effective than using pulsed dye laser alone and can serve as a novel treatment approach for these conditions. • The combined treatment of PDL and triamcinolone injection (at a concentration of 20 mg per 1 ml, with 1 ml injected for each lesion) is an effective option for managing hypertrophic and keloid scars. This approach is more effective than using PDL alone and can significantly improve hypertrophic and keloid scars. • The combination of PDL and triamcinolone injection, when compared to the combination of PDL and BTA injection, results in a more significant improvement in VSS reduction, especially regarding scar vascularity and height. • The greatest improvement in pliability was observed in the group that received PDL and BTA, followed by the group that received PDL and triamcinolone, while the group receiving PDL only showed the least improvement.

Botulinum toxin type A (BoNTA) products are widely used for therapeutic and aesthetic indications, but there is a need for longer-lasting treatments that maintain symptom relief between injections and reduce the frequency of re-treatment. DaxibotulinumtoxinA for Injection (DAXI) is a novel BoNTA product containing highly purified 150-kDa core neurotoxin and is the first to be formulated with a proprietary stabilizing excipient peptide (RTP004) instead of human serum albumin. The positively charged RTP004 has been shown to enhance binding of the neurotoxin to neuronal surfaces, which may enhance the likelihood of neurotoxin internalization. DAXI produces robust, extended efficacy across both aesthetic and therapeutic indications. In an extensive glabellar lines clinical program, DAXI showed a high degree of efficacy, a consistent median time to loss of none or mild glabellar line severity of 24 weeks, and median time until return to baseline of up to 28 weeks. In adults with cervical dystonia, DAXI at 125 U and 250 U significantly improved Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total scores, with a median duration of efficacy of 24 and 20 weeks, respectively, which compares favorably with the 12–14 weeks’ duration reported for approved BoNTA products. Overall, DAXI was well tolerated, and the consistent extended duration of effect suggests that DAXI has the potential to improve the management of both aesthetic and therapeutic conditions. Plain Language Summary Botulinum toxin is used to block the nerve signals that cause muscles to contract. Products containing botulinum toxin are commonly given by injection to treat muscle spasms (such as cervical dystonia, a painful condition where the neck muscles contract involuntarily) and for cosmetic treatment of frown lines. However, the effects of the currently approved botulinum toxin products typically wear off about 3–4 months after injection and so the injections must be repeated regularly. A new product called DAXI (DaxibotulinumtoxinA for Injection) has been developed. In this product, the botulinum toxin is formulated with a unique protein (called RTP004) that has been designed to help deliver the botulinum toxin to the nerve cells. Research suggests that the RTP004 protein in DAXI adheres the botulinum toxin to the nerves close to the injection site, potentially making its effect last longer. To date, DAXI has been studied in over 3800 patients. The studies have shown that DAXI is effective for treating neck spasms (cervical dystonia) and for reducing the appearance of frown lines. Importantly, the effects of DAXI lasted up to 6 months, which is longer than seen with other botulinum toxin products. The side effects seen with DAXI are consistent in nature and frequency with those seen with other botulinum toxin products. These findings suggest that DAXI can improve both medical and cosmetic treatments due to its longer-lasting effect.

Resistance from antagonistic muscle groups might be a crucial factor reducing function in chronic hemiparesis. The resistance due to spastic co-contraction might be reduced by botulinum toxin injections. We assessed the effects of abobotulinumtoxinA injection in the upper limb muscles on muscle tone, spasticity, active movement, and function. In this randomised, placebo-controlled, double-blind study, we enrolled adults (aged 18–80 years) at least 6 months after stroke or brain trauma from 34 neurology or rehabilitation clinics in Europe and the USA. Eligible participants were randomly allocated in a 1:1:1 ratio with a computer-generated list to receive a single injection session of abobotulinumtoxinA 500 U or 1000 U or placebo into the most hypertonic muscle group among the elbow, wrist, or finger flexors (primary target muscle group [PTMG]), and into at least two additional muscle groups from the elbow, wrist, or finger flexors or shoulder extensors. Patients and investigators were masked to treatment allocation. The primary endpoint was the change in muscle tone (Modified Ashworth Scale [MAS]) in the PTMG from baseline to 4 weeks. Secondary endpoints were Physician Global Assessment (PGA) at week 4 and change from baseline to 4 weeks in the perceived function (Disability Assessment Scale [DAS]) in the principal target of treatment, selected by the patient together with physician from four functional domains (dressing, hygiene, limb position, and pain). Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01313299. 243 patients were randomly allocated to placebo (n=81), abobotulinumtoxinA 500 U (n=81), or abobotulinumtoxinA 1000 U (n=81). Mean change in MAS score from baseline at week 4 in the PTMG was −0·3 (SD 0·6) in the placebo group (n=79), −1·2 (1·0) in the abobotulinumtoxinA 500 U group (n=80; difference −0·9, 95% CI −1·2 to −0·6; p<0·0001 vs placebo), and −1·4 (1·1) in the abobotulinumtoxinA 1000 U group (n=79; −1·1, −1·4 to −0·8; p<0·0001 vs placebo). Mean PGA score at week 4 was 0·6 (SD 1·0) in the placebo group (n=78), 1·4 (1·1) in the abobotulinumtoxinA 500 U group (n=80; p=0·0003 vs placebo), and 1·8 (1·1) in the abobotulinumtoxinA 1000 U group (n=78; p<0·0001 vs placebo). Mean change from baseline at week 4 in DAS score for the principal target of treatment was −0·5 (0·7) in the placebo group (n=79), −0·7 (0·8) in the abobotulinumtoxinA 500 U group (n=80; p=0·2560 vs placebo), and −0·7 (0·7) in the abobotulinumtoxinA 1000 U group (n=78; p=0·0772 vs placebo). Three serious adverse events occurred in each group and none were treatment related; two resulted in death (from pulmonary oedema in the placebo group and a pre-existing unspecified cardiovascular disorder in the abobotulinumtoxinA 500 U group). Adverse events that were thought to be treatment related occurred in two (2%), six (7%), and seven (9%) patients in the placebo, abobotulinumtoxinA 500 U, and abobotulinumtoxinA 1000 U groups, respectively. The most common treatment-related adverse event was mild muscle weakness. All adverse events were mild or moderate. AbobotulinumtoxinA at doses of 500 U or 1000 U injected into upper limb muscles provided tone reduction and clinical benefit in hemiparesis. Future research into the treatment of spastic paresis with botulinum toxin should use active movement and function as primary outcome measures. Ipsen.