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A double-blind, randomized, placebo-controlled, two-dose comparative study of botulinum toxin type A for treating glabellar lines in Japanese subjects.

ABSTRACT: BACKGROUND: Systematic, well-controlled clinical trials of botulinum toxin type A (BoNTA) in diverse patient populations are needed. The aim of this study was to characterize the safety and efficacy of 10-U and 20-U BoNTA doses versus placebo for treating glabellar lines in Japanese subjects. METHODS: A 16-week, multicenter, double-blind, randomized, placebo-controlled trial comparing 10 or 20 U of BoNTA versus placebo in 142 Japanese subjects with glabellar lines of at least moderate severity at maximal contraction. The primary efficacy endpoint was physician-rated line severity at maximal contraction 4 weeks after treatment. Secondary efficacy endpoints included physician/subject ratings and estimates of the effect's duration. RESULTS: Response rates by physician-rated line severity at maximal contraction (week 4) were 86.4% (10 U), 88.6% (20 U), and 0% (placebo, p < 0.001). Line severity at maximal contraction in each BoNTA group (p < 0.001) improved significantly from baseline at each visit. BoNTA and placebo differed significantly on all other efficacy measures. Mean duration of effect was 9.4 weeks in the 20-U group and 7.9 weeks in the 10-U BoNTA group. No serious adverse events occurred. CONCLUSION: Doses of BoNTA of 10 and 20 U are effective and safe for treating glabellar lines in Japanese subjects, and the 20-U dose provides greater efficacy and longer duration of effect.

SUBMITTER: Harii K

PROVIDER: S-EPMC2696607 | biostudies-other | 2008 Sep

REPOSITORIES: biostudies-other

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The Therapeutic Efficacy of Botulinum Toxin in Treating Scleroderma-Associated Raynaud's Phenomenon: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Project description:ObjectiveTo assess the therapeutic efficacy of local injections of botulinum toxin type A (Btx-A) in improving blood flow to the hands of patients with Raynaud's phenomenon (RP) secondary to scleroderma.MethodsIn this randomized, double-blind, placebo-controlled clinical trial, patients with scleroderma-associated RP received Btx-A (50 units in 2.5 ml sterile saline) in one randomly selected hand and sterile saline (2.5 ml) in the opposite hand. Follow-up at 1 and 4 months postinjection included laser Doppler imaging of hands, patient-reported outcomes, and physical examination. We compared outcomes using paired t-tests and population-average generalized models with generalized estimating equations.ResultsOf 40 patients enrolled, 25 had limited scleroderma and 15 had diffuse scleroderma. From baseline to 1-month follow-up, there was a greater reduction in average blood flow in Btx-A-treated hands compared to placebo-treated hands. The model estimated that this difference was statistically significant (average difference -30.08 flux units [95% confidence interval -56.19, -3.98], P for interaction = 0.024). This difference was mainly influenced by patients with longstanding RP and diffuse scleroderma. Change in blood flow at 4-month follow-up was not significantly different between groups. Clinical measures (QuickDASH, McCabe Cold Sensitivity Score, pain on a visual analog scale, and Raynaud's Condition Score) improved slightly for Btx-A-treated hands.ConclusionOur laboratory-based laser Doppler imaging flow data do not support using Btx-A to treat RP in all scleroderma patients. The secondary clinical outcomes suggest some positive effect, but its clinical meaningfulness is questionable. The role of Btx-A in treating RP should be further studied with more homogeneous patient populations and in unique clinical situations such as acute digital ischemia.

| S-EPMC5529251 | biostudies-literature

Botulinum Toxin in Restless Legs Syndrome-A Randomized Double-Blind Placebo-Controlled Crossover Study.

Project description:BACKGROUND:Restless Legs Syndrome (RLS) is a common movement disorder with an estimated prevalence of up to 12%. Previous small studies with onabotulinumtoxin A (OnaA) for RLS have shown inconsistent results. METHODS:Twenty-four patients with an International RLS score (IRLS) of >11 (moderate-severe) were enrolled in this blinded, placebo-controlled crossover study. Twenty-one patients completed the evaluations at 4, 6, and 8 weeks after each injection. One-hundred units of Incobotulinumtoxin A (IncoA) or normal saline were injected into tibialis anterior, gastrocnemius, and biceps femoris muscles each side. RESULTS:Improvement from a severe (IRLS >21) to a mild/moderate (IRLS ?20) score was significant at four weeks (p = 0.0036) and six weeks (p = 0.0325) following IncoA administration compared to placebo. Additionally, there was significant improvement in pain score at six weeks as measured by Visual Analogue Scale (p = 0.04) and the Johns Hopkins Quality of Life Questionnaire (p = 0.01) in the IncoA group. Definite or marked improvement on Patient Global Impression of Change was seen in 7 out of 21 patients in the IncoA group vs. 1 out of 21 patients in the placebo group at 4 weeks (p = 0.012). CONCLUSION:IncoA injection lead to a reduction in severity of RLS symptoms, pain score, and quality of life, without any adverse effects.

| S-EPMC6215171 | biostudies-literature

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

Project description:BackgroundBotulinum 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.ObjectiveOur aim was to assess whether intradermal injection with BTX-B is an effective treatment for hidradenitis suppurativa (HS).MethodsTwenty 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.ResultsThe 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.ConclusionBTX-B improves the quality of life in patients with HS. Furthermore, comorbidity between HS and hyperhidrosis is suggested.Trial registrationClinicalTrials.gov identifier: NCT03103074.

| S-EPMC7473957 | biostudies-literature

OnabotulinumtoxinA (botulinum toxin type A) for the treatment of Japanese patients with overactive bladder and urinary incontinence: Results of single-dose treatment from a phase III, randomized, double-blind, placebo-controlled trial (interim analysis).

Project description:OBJECTIVE:To evaluate the efficacy and safety of onabotulinumtoxinA (botulinum toxin type A) 100 U in patients with overactive bladder and urinary incontinence. METHODS:This was a phase III, randomized, double-blind, placebo-controlled trial in Japanese patients who were inadequately managed with overactive bladder medications (anticholinergics and/or ?3 -adrenergic receptor agonists). Eligible patients were randomized 1:1 to receive a single dose of either onabotulinumtoxinA or placebo into the detrusor muscle (n = 124 each). The primary end-point was the change in the number of daily urinary incontinence episodes at week 12 from baseline. Secondary end-points included volume voided per micturition, other symptomatic measures (urinary urgency incontinence, micturition, urgency and nocturia) and patient-reported outcomes. RESULTS:In the onabotulinumtoxinA group, there was a significantly greater decrease from baseline in the mean number of daily urinary incontinence episodes compared with the placebo group (2.16; P < 0.001), and significantly greater improvement for all secondary end-points (P < 0.05). Urinary tract infection, dysuria, urinary retention and post-void residual urine volume increased represented adverse events occurring at a higher rate in the onabotulinumtoxinA group. The majority of these were mild or moderate in severity. CONCLUSIONS:Statistically significant and clinically relevant improvements in symptoms and patient-reported outcomes, and tolerability were seen in patients with overactive bladder and urinary incontinence who had been inadequately managed with overactive bladder medications after using onabotulinumtoxinA.

| S-EPMC7154639 | biostudies-literature

Treating Congenital Mirror Movements with Botulinum Toxin.

Project description: Not available

| S-EPMC6353364 | biostudies-literature

Intradermal Botulinum Toxin A Injection for Scalp Sebum Secretion Regulation: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Prospective Study in Chinese Subjects.

Project description:BackgroundAlthough botulinum toxin type A (BTX-A) injection has been proved to reduce topical sebum secretion, the impact of intradermal BTX-A injection on scalp sebum production has never been reported.ObjectivesThe purpose of this study was to investigate the efficacy and safety of intradermal BTX-A treatment vs intradermal normal saline (NS) injection for scalp sebum secretion regulation.MethodsThis multicenter, randomized, double-blinded, prospective study recruited patients complaining of oily scalp and/or hair. The patients were randomly allocated to receive either 1 session of intradermal BTX-A or NS injection. The baseline and posttreatment scalp sebum secretion at 24, 48, 72, and 96 hours postshampooing was measured with a Sebumeter SM815 (Cutometer Dual MPA 580, Courage & Khazaka, Cologne, Germany) at 1, 3, 4, and 6 months after treatment. The patients' comments, satisfaction, and adverse events were evaluated and compared.ResultsIn total, 25 patients in the BTX-A group and 24 patients in the NS group completed the follow-up. For the treated region, compared with NS, intradermal BTX-A treatment (50-65 U) significantly reduced scalp sebum secretion at 24, 48, and 72 hours postshampooing at the 1- and 3-month follow-up visits (P < 0.05). No significant difference between the 2 groups was observed at 4 and 6 months after the treatment. The patients' satisfaction ratings were significantly higher for the BTX-A treatment (P = 0.000). No serious adverse events occurred.ConclusionsCompared with NS, 1 session of intradermal BTX-A injection (50-65 U) effectively and safely reduced scalp sebum secretion and greasiness perception in the treated region at 24 and 48 hours postshampooing for 3 months.Level of evidence: 4

| S-EPMC9897178 | biostudies-literature

Acute dose-dependent effects of lysergic acid diethylamide in a double-blind placebo-controlled study in healthy subjects.

Project description:Growing interest has been seen in using lysergic acid diethylamide (LSD) in psychiatric research and therapy. However, no modern studies have evaluated subjective and autonomic effects of different and pharmaceutically well-defined doses of LSD. We used a double-blind, randomized, placebo-controlled, crossover design in 16 healthy subjects (eight women, eight men) who underwent six 25 h sessions and received placebo, LSD (25, 50, 100, and 200 µg), and 200 µg LSD 1 h after administration of the serotonin 5-hydroxytryptamine-2A (5-HT2A) receptor antagonist ketanserin (40 mg). Test days were separated by at least 10 days. Outcome measures included self-rating scales that evaluated subjective effects, autonomic effects, adverse effects, plasma brain-derived neurotrophic factor levels, and pharmacokinetics up to 24 h. The pharmacokinetic-subjective response relationship was evaluated. LSD showed dose-proportional pharmacokinetics and first-order elimination and dose-dependently induced subjective responses starting at the 25 µg dose. A ceiling effect was observed for good drug effects at 100 µg. The 200 µg dose of LSD induced greater ego dissolution than the 100 µg dose and induced significant anxiety. The average duration of subjective effects increased from 6.7 to 11 h with increasing doses of 25-200 µg. LSD moderately increased blood pressure and heart rate. Ketanserin effectively prevented the response to 200 µg LSD. The LSD dose-response curve showed a ceiling effect for subjective good effects, and ego dissolution and anxiety increased further at a dose above 100 µg. These results may assist with dose finding for future LSD research. The full psychedelic effects of LSD are primarily mediated by serotonin 5-HT2A receptor activation.

| S-EPMC8027607 | biostudies-literature

Botulinum toxin type-A in the prophylactic treatment of medication-overuse headache: a multicenter, double-blind, randomized, placebo-controlled, parallel group study.

Project description:Medication-overuse headache (MOH) represents a severely disabling condition, with a low response to prophylactic treatments. Recently, consistent evidences have emerged in favor of botulinum toxin type-A (onabotulinum toxin A) as prophylactic treatment in chronic migraine. In a 12-week double-blind, parallel group, placebo-controlled study, we tested the efficacy and safety of onabotulinum toxin A as prophylactic treatment for MOH. A total of 68 patients were randomized (1:1) to onabotulinum toxin A (n = 33) or placebo (n = 35) treatment and received 16 intramuscular injections. The primary efficacy end point was mean change from baseline in the frequency of headache days for the 28-day period ending with week 12. No significant differences between onabotulinum toxin A and placebo treatment were detected in the primary (headache days) end point (12.0 vs. 15.9; p = 0.81). A significant reduction was recorded in the secondary end point, mean acute pain drug consumption at 12 weeks in onabotulinum toxin A-treated patients when compared with those with placebo (12.1 vs. 18.0; p = 0.03). When we considered the subgroup of patients with pericranial muscle tenderness, we recorded a significant improvement in those treated with onabotulinum toxin A compared to placebo treated in both primary (headache days) and secondary end points (acute pain drug consumption, days with drug consumption), as well as in pain intensity and disability measures (HIT-6 and MIDAS) at 12 weeks. Onabotulinum toxin A was safe and well tolerated, with few treatment-related adverse events. Few subjects discontinued due to adverse events. Our data identified the presence of pericranial muscle tenderness as predictor of response to onabotulinum toxin A in patients with complicated form of migraine such as MOH, the presence of pericranial muscle tenderness and support it as prophylactic treatment in these patients.

| S-EPMC3139089 | biostudies-literature

Botulinum toxin injections for Japanese patients with urinary incontinence caused by neurogenic detrusor overactivity: Clinical evaluation of onabotulinumtoxinA in a randomized, placebo-controlled, double-blind trial with an open-label extension.

Project description:ObjectiveTo assess the efficacy and safety of botulinum toxin treatment (onabotulinumtoxinA 200 units) for Japanese patients with neurogenic detrusor overactivity caused by spinal cord injury or multiple sclerosis.MethodsPatients with urinary incontinence refractory to pharmacological treatment were enrolled and randomized in a phase III trial. A single dose of onabotulinumtoxinA (n = 11) or placebo (n = 10) was given in the double-blind phase, and repeat injections of onabotulinumtoxinA were given in the subsequent open-label phase. Outcomes included urinary incontinence episodes, urodynamics, patient-reported outcomes and adverse events.ResultsThe onabotulinumtoxinA group showed a numerically greater reduction in the number of urinary incontinence episodes per day than the placebo group, with the difference between the groups at week 6 of -3.02 (95% confidence interval -5.85 to -0.19). The onabotulinumtoxinA group also showed greater improvements in urodynamic assessments. Adverse events related to onabotulinumtoxinA injections were hematuria, urinary retention, urinary bladder hemorrhage, autonomic dysreflexia and epididymitis. Most events were deemed mild or moderate.ConclusionsIntradetrusor injections of onabotulinumtoxinA are efficacious and tolerable for Japanese patients with neurogenic detrusor overactivity-related symptoms that are difficult to manage with anticholinergics and/or β3 -adrenergic receptor agonists.

| S-EPMC8453759 | biostudies-literature

A randomized, double-blind, placebo-controlled, dose-finding trial with Lolium perenne peptide immunotherapy.

Project description:A novel subcutaneous allergen immunotherapy formulation (gpASIT+™) containing Lolium perenne peptides (LPP) and having a short up-dosing phase has been developed to treat grass pollen-induced seasonal allergic rhinoconjunctivitis. We investigated peptide immunotherapy containing the hydrolysate from perennial ryegrass allergens for the optimum dose in terms of clinical efficacy, immunogenicity and safety.This prospective, double-blind, placebo-controlled, phase IIb, parallel, four-arm, dose-finding study randomized 198 grass pollen-allergic adults to receive placebo or cumulative doses of 70, 170 or 370 ?g LPP. All patients received weekly subcutaneous injections, with the active treatment groups reaching assigned doses within 2, 3 and 4 weeks, respectively. Efficacy was assessed by comparing conjunctival provocation test (CPT) reactions at baseline, after 4 weeks and after completion. Grass pollen-specific immunoglobulins were analysed before and after treatment.Conjunctival provocation test (CPT) response thresholds improved from baseline to V7 by at least one concentration step in 51.2% (170 ?g; P = .023), 46.3% (370 ?g), and 38.6% (70 ?g) of patients receiving LPP vs 25.6% of patients receiving placebo (modified per-protocol set). Also, 39% of patients in the 170-?g group became nonreactive to CPT vs 18% in the placebo group. Facilitated allergen-binding assays revealed a highly significant (P < .001) dose-dependent reduction in IgE allergen binding across all treatment groups (70 ?g: 17.1%; 170 ?g: 18.8%; 370 ?g: 26.4%). Specific IgG4 levels increased to 1.6-fold (70 ?g), 3.1-fold (170 ?g) and 3.9-fold (370 ?g) (mPP).Three-week immunotherapy with 170 ?g LPP reduced CPT reactivity significantly and increased protective specific antibodies.

| S-EPMC5947135 | biostudies-other

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