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CRO Services for Toxins (Neuromodulators)

ethica has been engaged in aesthetic toxins research from the beginning, collaborating with pioneering researchers exploring diverse cosmetic uses.

With a historical role in botulinum toxins development for aesthetic purposes, ethica CRO has been pivotal in cosmetic toxin research since the 1990s. We have extensive experience in a variety of toxin applications worldwide, conducting both registered and observational studies, making significant contributions to the field.

Safety & Efficacy

Rigorous trials, prioritizing safety and data integrity to confidently support your claim to regulators and the public.

Combination Treatment

We excel in standalone toxin and combination treatment effectiveness assessments.

Medical Affairs Research

We are experienced in assessing long-term safety, patient satisfaction, and real-world efficacy of toxins.

Discover how our clinical expertise can benefit your clinical trials for toxins (neuromodulators).

Our main concern is participant’s safety. Avoiding complications such as temporary ptosis is a critical consideration in toxin-based research.  We emphasize the importance of using effective research methodologies to demonstrate treatment safety, effectiveness and duration, which are crucial for gaining FDA approval.

Additionally, our expertise extends to medical affairs and product positioning, enhancing market success. Our extensive experience encompasses clinical research and medical affairs, making us a comprehensive resource in the field of toxins.

Our expertise for neurotoxin clinical trials

Our biotech CRO has unparalleled expertise in neurotoxins, spanning both aesthetic and therapeutic applications. We conducted the groundbreaking exploratory research that laid the foundation for pivotal studies, ultimately securing FDA approval for neurotoxins across a wide range of aesthetic and therapeutic indications.

Our pioneering work has left an indelible mark on the field, guiding decision-makers and shaping the landscape of neurotoxin applications. We have conducted research on the following indications:

Aesthetic

  • Glabellar
  • Forehead
  • Crow’s feet
  • Bunny lines
  • Lip rhytids
  • Mentalis
  • Brow lift
  • Combinations (fillers + toxins)

Medical

  • Migraine
  • Overactive bladder / NDO
  • Post-stroke spasticity
  • Hyperhidrosis
  • Cervical dystonia
  • TMJ disorder
  • Anal fissure

Various

  • Patient satisfaction
  • Social perception
  • Onset of action
  • Duration of action
  • Antibody development
  • Diffusion
  • Retrospective chart reviews

Innovative toxin research

Our dermatology CRO conducted the first clinical study on neurotoxin and dermal filler combinations for lower-face rejuvenation.  The results indicated that the combination therapy is safe and provides superior efficacy to either modality when used alone

Case Study: The First Long-term Study to Show the Safety and Efficacy of OnabotulinumtoxinA in a Real-world Setting

The therapeutic use of onabotulinumtoxinA, first reported in the 1990s, has obtained regulatory approvals for various aesthetic applications, including treatment for glabellar lines and crow’s feet. Despite known efficacy and safety, long-term patient satisfaction data was limited due to the short duration of most clinical trials, with the longest documented satisfaction being from a 26-month study.

To fill this gap, a U.S. aesthetic company aimed to evaluate the long-standing satisfaction and safety of onabotulinumtoxinA facial treatments and examine the evolution of aesthetic practices over time. The client, a market leader in aesthetic solutions, had engaged with ethica on over 50 onabotulinumtoxinA studies. The challenge was to overcome the limitations of retrospective analysis, such as data integrity, consistent treatment application, and unbiased patient-reported outcomes over extended periods.

ethica CRO proceeded with the design and management of a comprehensive international, multicenter, retrospective chart review with a cross-sectional prospective analysis in 11 locations worldwide. The solution involved meticulous management of all study logistics across diverse healthcare settings and regulatory environments.

This initiative yielded two significant publications that affirmed the safety and satisfaction of long-term onabotulinumtoxinA use, providing valuable insights for the client’s medical affairs team, while marking an influential contribution to aesthetic medicine research.