Clinical Research: Phase 1 - Phase 4

5 Key Takeaways: Drug and Device Development Secrets in the World of Medical Aesthetics

New treatment options for medical aesthetic indications are in record-high demand, fueled by growing awareness of the effects of physiological and environmental aging and the influence of lifestyle on skin health. By 2025, the global aesthetic medicine market is projected to be $22.8 billion, nearly one-third of which is expected to be dermal fillers. In this blog, we discuss five of the most important takeaways for creating a competitive, differentiated aesthetic development program.

1. Recognize aesthetic market segmentation and trends. When exploring clinical development strategy options, aesthetic developers should consider product and application segments, regional market needs, key competitors, and trends that are positively impacting market growth. North America is currently the top market for medical aesthetics. Among multiple emerging markets, Asia-Pacific and South America are poised for the highest growth. Notably, the pandemic has led to a significant increase in the use of at-home aesthetic devices. Other market drivers include:

  • Development of efficient, cost-effective alternatives to cosmetic surgery
  • Growing adoption of minimally invasive and non-invasive aesthetic procedures
  • Wider availability of advanced technology and user-friendly solutions
  • Upsurge in cosmetic procedures among those over age 55
  • Increasing demand for aesthetic solutions among men

2. Get to know your patients and involve them in the clinical development process. Different segments of the patient population gravitate toward different aesthetic procedures. While the number one non-surgical cosmetic procedure among both women and men is neurotoxin injections, the number two procedure for women is soft tissue fillers and for men is laser hair removal. Understanding when and how patients utilize procedures can help developers create relevant, competitive solutions that address an unmet need. Involving patients as early as possible in clinical development is useful for defining relevant endpoints, designing patient-focused studies, and developing effective recruitment and retention strategies.

3. Build a competitive target product profile. The market is demanding more effective, more convenient, and safer aesthetic solutions. Patients are seeking greater extent and speed of effect with no adverse effects and, ideally, no downtime. Building a target product profile helps developers identify and validate the indication, patient population, market positioning, method and setting of administration, stakeholders, and pricing.

4. Understand the regulatory framework for product safety and efficacy. The rapid growth of the aesthetic medicine industry presents challenges for both sponsors and regulators. For instance, the distinction between regulated and non-regulated products is not always clear-cut, and product categorization may differ across geographies, creating regulatory complexity. Drawing the line between the clinic and home use may also be a source of confusion.

In our experience, regulatory agencies are open to working together with developers to figure out how to move innovative products forward while protecting patient safety, so engaging with them early and often can help to optimize the development pathway. Regulators are also increasingly interested in a balance of data collected in a controlled environment and data collected in real-world settings.

5. Develop and implement a well-designed clinical trial. Selecting an appropriate methodology for interventional studies is essential to obtain valid conclusions. Often, the choice of comparator and study design will depend on the region and the relevant regulatory authority. While a fully blinded study is preferred, it may not be possible to blind the main investigator who is administering the treatment. If this is the case, it is important to blind the patient and obtain primary effectiveness assessments from a blinded evaluation.

When primary efficacy endpoints are not measurable, they can be rated by validated assessment scales that have been adapted to the indication and population under investigation. Patient-reported outcomes (PROs) are often co-primary endpoints in pivotal aesthetic studies and will ultimately appear on the product label. PROs can be a powerful tool for communicating the differentiated value of the drug or device.

In an increasingly competitive landscape, an aesthetic clinical development program needs to be aligned with a business strategy aimed at demonstrating superiority to all stakeholders, from regulators and providers to patients and consumers and payers when applicable. A thorough understanding of the market, asset, and patient helps developers identify unmet needs and opportunities to carve their niche in this rapidly growing industry.