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3,473 result(s) for "Botulinum toxin type A"
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Trial of Botulinum Toxin for Isolated or Essential Head Tremor
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.
Exploring botulinum toxin’s impact on masseter hypertrophy: a randomized, triple-blinded clinical trial
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.
Hyaluronic acid versus botulinum a toxin injection in the treatment of premature ejaculation: A comparative study
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.
Efficacy and Safety of Letibotulinum Toxin A for the Treatment of Melasma in Two Different Dilutions: A Randomized Double-Blind Split-Face Study
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.
A 12-Week Prospective, Double-Blind, Multicenter, Randomized Study Comparing 100 Units of Abobotulinum Toxin Type A (Dysport®) and 33.33 Units of Neubotulinum Toxin Type A (Neuronox®) for the Treatment of Hemifacial Spasm
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.
Two doses of botulinum toxin type A for the treatment of trigeminal neuralgia: observation of therapeutic effect from a randomized, double-blind, placebo-controlled trial
Background In the majority of cases, trigeminal neuralgia (TN) is a unilateral condition with ultra-short stabbing pain located along one or more branches of the trigeminal nerve. Although prophylactic pharmacological treatment is first choise, considering of insufficient effect or unacceptable side effects, neurosurgical treatment or lesion treatment should be considered. In addition to all these procedures mentioned above, one approach has been based on local intradermal and/or submucosal injections of Botulinum Toxin Type A (BTX-A). Methods We conducted a randomized, double-blind, placebo-controlled since November 2012, and adopted local multi-point injection in 84 cases of classical TN with different doses of BTX-A. Eighty four patients were randomized into following groups: placebo (n = 28); BTX-A 25U (n = 27); BTX-A 75U (n = 29). Follow-up visits were conducted every week after the injection, and the overall duration of the study for each patient were 8 weeks to observe the pain severity, efficacy and adverse reactions at endpoint. Results The visual analogue scale (VAS) scores of 25U and 75U groups reduced significantly compared to placebo as early as week 1, and sustained until week 8 throughout the study. There was no significant difference in VAS between 25U and 75U groups throughout the study. The response rates of 25U group (70.4%) and 75U group (86.2%) were significantly higher than placebo group (32.1%) at week 8, and there was no significant difference between 25U and 75U groups. Evaluation of the Patient Global Impression of Change (PGIC) demonstrated that 66.7% (25U group) and 75.9% (75U group) of the patients reported that their pain symptoms were ‘much improved’ or ‘very much improved’ versus 32.1% of the placebo group, and there was also no significant difference between 25U and 75U groups. All adverse reactions were graded as mild or moderate. Conclusions BTX-A injection in TN is safe and efficient. It is a useful treatment for refractory TN. Lower dose (25U) and high dose (75U) were similar in efficacy in short-term.
Evaluating the effectiveness and safety of pulsed dye laser alone, the combination of pulsed dye laser and botulinum toxin type A, and the combination of pulsed dye laser and triamcinolone injection in the treatment of hypertrophic and keloid scars: a three-arm randomized controlled clinical trial
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.
Triamcinolone acetonide and botulinum toxin A for upper eyelid retraction in thyroid-associated ophthalmopathy
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).
Botulinum Toxin to Improve Results in Cleft Lip Repair: A Double-Blinded, Randomized, Vehicle-Controlled Clinical Trial
Most patients with facial scarring would value even a slight improvement in scar quality. Botulinum toxin A is widely used to alleviate facial dynamic rhytides but is also believed to improve scar quality by reducing wound tension during healing. The main objective was to assess the effect of Botulinum toxin on scars resultant from standardized upper lip wounds. In this double-blinded, randomized, vehicle-controlled, prospective clinical trial, 60 consecutive consenting adults undergoing cleft lip scar revision (CLSR) surgery between July 2010 and March 2012 were randomized to receive botulinum toxin A (n = 30) or vehicle (normal saline; n = 30) injections into the subjacent orbicularis oris muscle immediately after wound closure. Scars were independently assessed at 6-months follow-up in blinded fashion using: Vancouver Scar Scale (VSS), Visual Analogue Scale (VAS) and photographic plus ultrasound measurements of scar widths. 58 patients completed the trial. All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group. Quality of surgical upper lip scars, which are oriented perpendicular to the direction of pull of the underlying orbicularis oris muscle, is significantly improved by its temporary paralysis during wound healing. ClinicalTrials.gov NCT01429402.
Efficacy and Safety of Botulinum Toxin Type A on Persistent Myofascial Pain: A Randomized Clinical Trial
This study assessed the safety and efficacy of three different doses of BoNT-A for persistent myofascial pain (MFP). One hundred female subjects were randomly assigned into five groups (n = 20): oral appliance (OA), saline solution (SS) and three BoNT-A groups with different doses. Pain intensity and pressure pain threshold were evaluated up to 24 weeks after treatment. Adverse effects related to muscle contraction, masticatory performance, muscle thickness and mandibular bone volume were also assessed. Changes over time were compared within and between groups. The “nparLD” package and Wilcoxon signed-rank test were used to analyze the data. BoNT-A reduced pain intensity (p < 0.0001) and increased pressure pain threshold (p < 0.0001) for up to 24 weeks compared to the placebo. No differences were found between BoNT-A and OA at the last follow-up. A transient decline in masticatory performance (p < 0.05) and muscle contraction (p < 0.0001), and a decrease in muscle thickness (p < 0.05) and coronoid and condylar process bone volume (p < 0.05) were found as dose-related adverse effects of BoNT-A. Regardless of the dose, BoNT-A was as effective as OA on MFP. Notwithstanding, due to BoNT-A dose-related adverse effects, we suggest the use of low doses of BoNT-A in MFP patients that do not benefit from conservative treatments.