A pilot study comparing the efficacy of two formulations of botulinum toxin type A for muscular calves contouring

Wanitphakdeedecha, Rungsima; Ungaksornpairote, Chanida; Kaewkes, Arisa; Sathaworawong, Angkana; Vanadurongwan, Bavornrat; Lektrakul, Nittaya

doi:10.1111/jocd.12787

Cited by 20 publications

(15 citation statements)

References 19 publications

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“…23 By utilizing the only state-of-the-art manufacturing process that employs a 2-step chromatographic purification process to extract from the complexing proteins and leave just the active 150kDa molecule, INCO provides the lowest protein load available compared to other BoNT/A formulations. 1,[24][25][26][27][28][29] INCO contains 0.44ng 150kDa neurotoxin per 100U (0.088 ng/20U dose) and has a high specific activity of 227U/ng, consistent with no denaturing of the BoNT complex during the INCO chromatographic purification process. [24][25][26][27][28][29] In contrast, ONA, ABO, and PRA all contain complexing proteins and/or denatured BoNT protein that may initiate an immune response, leading to production of neutralizing antibodies that can be associated with decreased effect over time or treatment non-response.…”

Section: Safetymentioning

confidence: 99%

“…1,[24][25][26][27][28][29] INCO contains 0.44ng 150kDa neurotoxin per 100U (0.088 ng/20U dose) and has a high specific activity of 227U/ng, consistent with no denaturing of the BoNT complex during the INCO chromatographic purification process. [24][25][26][27][28][29] In contrast, ONA, ABO, and PRA all contain complexing proteins and/or denatured BoNT protein that may initiate an immune response, leading to production of neutralizing antibodies that can be associated with decreased effect over time or treatment non-response. 24,31 Investigational drug DaxibotulinumtoxinA (DAXI; RT002, Revance Therapeutics Inc.) contains a virally-derived protein transduction domain (PTD), as part of an added excipient and stabilizer (RTP004).…”

Section: Safetymentioning

confidence: 99%

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IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines

Kerscher¹,

Fabi²,

Fischer³

et al. 2020

JDD

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Background: Recently reported clinical data provides evidence that increasing the dose of botulinum toxin A increases the duration of efficacy. A 2-stage Phase 2, randomized, double-blind study investigated the duration of effect and safety of IncobotulinumtoxinA (INCO; Xeomin ® , Bocouture ® ; Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) at doses higher than the approved 20 units (U) for glabellar frown lines (GFL). Primary safety and efficacy endpoints of Stage 1 are reported here. Methods: 151 subjects with moderate-to-severe GFL were randomized 1:2:2 to receive a single treatment with 20U, 50U, or 75U INCO. The primary efficacy endpoint was median duration of at least 1-point improvement from baseline as assessed by investigator at maximum frown on the Facial Wrinkle Scale. Results: The median duration of effect was 185 days for the 50U dose group (95% CI:[182, 205]) and 210 days for the 75U dose group (95% CI:[182, 217]). Duration of effect was significantly longer for 75U vs 50U (P=0.0400) and 20U (P=0.0166) despite the study not being powered for confirmatory statistical significance testing between the dose groups. Duration of effect was also longer for 50U vs 20U, however; statistical significance was not reached (P=0.4349). The incidence of treatment-related adverse events was low across all doses (20U:2[6.7%], 50U:6[10.0%] and 75U:8[13.1%]). Conclusions: These results demonstrate a dose effect of at least 6 months duration with higher doses in the majority of GFL subjects. All doses were well tolerated and safety was consistent with the known safety profile of 20U INCO for GFL.

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Section: Safetymentioning

confidence: 99%

Section: Safetymentioning

confidence: 99%

IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines

Kerscher¹,

Fabi²,

Fischer³

et al. 2020

JDD

View full text Add to dashboard Cite

show abstract

“…Patients came in for follow‐ups visits at 1 and 6 months and were evaluated with clinical photography, calf‐circumference measurement, isokinetic analysis, and ultrasonographic imaging. Both patients' satisfaction rate and doctor's evaluation showed no statistical difference between the two formulations and thus the study showed that PRA and ONA provide comparable efficacy in calf reductions in hypertrophic gastrocnemius muscles 48 …”

Section: Resultsmentioning

confidence: 72%

“…Both patients' satisfaction rate and doctor's evaluation showed no statistical difference between the two formulations and thus the study showed that PRA and ONA provide comparable efficacy in calf reductions in hypertrophic gastrocnemius muscles. 48…”

Section: Calf Contouringmentioning

confidence: 99%

Emerging off‐label esthetic uses of botulinum toxin in dermatology

Phan

Younessi

Dubin

et al. 2021

Dermatologic Therapy

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Botulinum toxin is a neurotoxic protein produced by Clostridium botulinum, the bacterium responsible for botulism. Botulinum toxin was first used for therapeutic indications in the 1970s for the treatment of strabismus. With greater understanding of its underlying physiology and safety profile, the use of botulinum toxin has now expanded to a range of cosmetic and medical indications. We performed a systematic review of current literature on the applications of botulinum toxin on off-label esthetic uses. Electronic databases were searched for original published studies including randomized trials, observational or cohort studies, as well as relevant case reports. To add to the body of evidence, our review summarizes and synthesizes key study characteristics, results, and level of evidence for each use case. Although the body of evidence remains weak, there is increasing support for the use of botulinum toxin in emerging off-label esthetic uses of botulinum toxin in dermatology.

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“…Growing demand for safer and less painful procedures for achieving slim body contour has led to the development of several noninvasive modalities including botulinum toxin type A (BTX-A). [1][2][3][4][5][6] To the best of our knowledge, no clinical study has been conducted to assess the aesthetic effect of BTX-A on deltoid muscle hypertrophy. Therefore, we conducted a pilot study to determine the efficacy and safety of intramuscular BTX-A injection in reducing deltoid muscle hypertrophy in Asian women.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of botulinum toxin injection in reducing deltoid muscle hypertrophy

Shin

Park

Yeoum

et al. 2021

Dermatologic Therapy

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With the increasing demand for body contouring, botulinum toxin (BTX) injection is being widely used off-label for muscular hypertrophy. However, to the best of our knowledge, no study has investigated the clinical efficacy of BTX type A (BTX-A) in deltoid muscle hypertrophy. This study was conducted to evaluate the efficacy and safety of intramuscular injection of BTX in reducing deltoid muscle hypertrophy.Overall, 10 patients with bilateral deltoid muscle hypertrophy were treated with an intramuscular injection of prabotulinum toxin A, with a total of 50 units [U] administered per patient. As measured by ultrasonography, the thickness of the deltoid muscles was significantly decreased at weeks 2 and 12. In addition, the clinical assessment score by blinded investigators was improved after the treatment; however, patients' satisfaction scores were relatively low. No major complications were reported. Therefore, intramuscular injection of BTX-A seems to be a candidate for novel treatment option for deltoid muscle hypertrophy. Further larger clinical studies are warranted to confirm the efficacy of BTX-A.

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A pilot study comparing the efficacy of two formulations of botulinum toxin type A for muscular calves contouring

Abstract: This study demonstrated that PRA and ONA provided comparable efficacy and safety in gastrocnemius muscle reduction.

Cited by 20 publications

References 19 publications

IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines

IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines

Emerging off‐label esthetic uses of botulinum toxin in dermatology

Efficacy and safety of botulinum toxin injection in reducing deltoid muscle hypertrophy

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