Introduction: Botulinum toxin is a protein complex widely used to treat muscle kinesis for aesthetic concerns such as dynamic facial rhytids or contouring as well as for a range of therapeutic concerns in dermatology. Several different formulations of botulinum toxin have received Food and Drug Administration approval for cosmetic indications. These are however not interchangeable in dosing and cannot be compared unit-for-unit. Stunnox ™ , is an onabotulinum toxin Type-A, indigenously manufactured in India using the Prime Bio USA MCL 44 strain. A panel of seven experts and one reviewer doctor evaluated the brand using the modified Delphi method. The purpose of this evaluation was to assess the safety, efficacy, and longevity of Stunnox ™ and establish a consensus guideline for dosing in the treatment of upper facial dynamic rhytids in male and female patients in the Indian population. The longevity assessment of the clinical effect was done for a study period from January through October 2025. These consensus recommendations are intended as a general guideline for the users of Stunnox ™ and do not supersede individual discretion and physician decision-making, which may change due to dose-modifying factors. It helps physicians to incorporate the use of Stunnox ™ smoothly into their clinical practice and recommends further randomized controlled trials and head-to-head trials with existing international brands for further validation to improve patient outcomes. Background and Objectives: This consensus guideline is a recommendation to assess safety, efficacy, and dosing in the Indian population, the longevity of Stunnox ™ and to validate that it is equipotent to global brands. The dosing guidelines are for male and female Indian patients aged 20–40 years, with mild to moderate rhytids of the upper face. Material and Methods: The consensus recommendations presented are by seven experts, among whom are dermatologists and plastic surgeons, using botulinum toxin in day-to-day esthetic practice. It is presented according to the modified Delphi consensus, with two rounds of physical meetings. All seven experts observed two of their patients (one male and one female, 20–40 years of age) who were administered Stunnox ™ for forehead, glabellar complex, and lateral canthal lines for its onset of action, duration of effect, and complications, for 6 months, with the aim to provide inputs for this consensus. Four weeks after treatment of the patients and before the physical meetings, Google forms with a questionnaire were mailed to all the experts. The results were presented and deliberated upon in the meetings. A >85% agreement on the deliberations upon a question was taken as final in both the meetings. Less than a 85% consensus on a particular question in the first round was deliberated upon in the second round, asking the concerned expert to provide a reasoning, and a re-evaluation was done. Results: Out of the seven experts, more than 85% agreed that the onset of action was between 24 and 48 h post-injection and the time to peak effect was 7–10 days. 100% of the experts agreed that there was no injection site reaction and no untoward effect after 72 h. More than 85% agreed that Stunnox ™ was more potent clinically than other brands in standard dosing. The dosing recommendation for Stunnox ™ for the glabellar rhytids in females was between 10 and 16 U and in males between 12 and 18 U as agreed upon by the definition of the consensus. The dose range for the forehead rhytids was 7–10 U and 9–12 U for females and males, respectively. The lateral canthal line dose recommendations according to the consensus were 6–9 U for females and 9–12 U for males, respectively, according to >85% consensus. 100% experts agreed that dose-modifying factors such as patient gender, muscle bulk, and muscle activity played a role. All panellists also agreed that the ethnicity of the patient played a role. Conclusion: According to the consensus guidelines, Stunnox TM exhibited favourable efficacy and safety with favourable patient outcomes and satisfaction. The dosing makes it stand out as having greater “clinical” potency, faster onset of action and early peak effect when compared to other ona botulinum toxin brands. More studies with larger cohorts are needed to arriive to a definitive conclusion with diffusion studies needed between different brands.
Arora et al. (Fri,) studied this question.
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