The quest to maintain the appearance of youth has fueled widespread use of injectable dermal fillers—and a deeply competitive landscape. A host of approved products are readily available in the United States, used to ameliorate nasolabial folds, perioral lines, lips, midface, dorsum of the hands and the chin, infra-orbital hollows, jawline, and fine lines everywhere. Still other indications—including temples, nose, and necklines—are under exploration. While this robust activity is promising for patients, it creates challenges for sponsors.
Sites, Subjects, Skills, and Safety: Key Challenges for Dermal Filler Clinical Trials
In any field, popularity creates demand, and demand creates scarcity. For dermal filler clinical studies, both investigative sites and study subjects are highly sought after; that competition places both recruitment and retention at risk. Further, under an Investigational Device Exemption (IDE) application, the FDA may require a controlled, randomized, evaluator-blinded, multi-center clinical trial with safety and effectiveness demonstrated against an approved comparator product. This requires proactive care in choosing and sourcing the right comparator. Further challenges arise based on patient profiles, investigator profiles, and data consistency. Specific concerns include:
- Diverse Patient Population: To demonstrate safety and efficacy across a range of skin types, sites will likely need to be able to recruit and retain diverse study participants based on an approved classification system. The FDA also may require both male and female subjects.
- Investigator Skills: To avoid inter- and intra-operator variability, both participating investigators and blinded evaluators need to have uniform injection techniques and use validated aesthetic scales to measure volume deficits. Training may be required.
- Safety Reviews: To address growing FDA safety concerns, Ophthalmologists and Neurologists may need to participate in reviews of safety data. As such, site selection should consider adequate staffing and access to practitioners in these specialties.
- Data Quality and Data Analysis: With Patient Reported Outcomes serving as a crucial source of data regarding both safety and efficacy, data collection quality and consistency are a high priority.
Fortunately, with expertise and proactive planning, each of these concerns can be overcome.
Experience-Based Strategy and Planning: The Bedrock of Success
To start, it’s critical to consider each study holistically, then build an overarching strategy. A cross-disciplinary team of experts spanning dermatology, medical device trial management, and project leadership must carefully craft the trial design to meet every requirement of the IDE application.
Then the team should leverage their real-world experience to plan each component in detail, starting at site selection. Site selection is foundational to success. The right sites will have proven track records in dermal studies; be proximate to a diverse patient population, with affiliated investigators who can help recruit patients; and have ophthalmologists and neurologists on staff.
Patient recruitment comes next, with close tracking of enrollment cohorts to ensure cross-spectrum diversity. Real-time randomization and enrollment progress of skin type cohorts and subgroups minimizes delays in recruiting challenging skin-type subgroups. Studies can optimize retention through proactive consideration of a range of potential issues such as holiday seasons.
Finally, teams should keep a laser focus on every area that impacts data quality. That starts with comparator procurement and supply, and extends to a range of risk management techniques, many of which are technology based. This is crucial when much of the data stem from Patient Reported Outcomes. An ideal system tracks and manages data integrity, identifying key risk indicators. It also provides real-time oversight of primary and secondary endpoint data, mitigating the threat of missing data points, ambiguous data points, and scale-rater variability, while flagging data trends and reported adverse events of special interest.
Together, these strategies enable the team and sponsors to keep a close eye on project milestones, concerns, and successes.
Specialized Challenges Call for Specialized Expertise
With the ever-growing demand for dermal fillers, sponsors face unique challenges in running effective clinical trials. There is increased competition for sites with skilled investigators and specialist practitioners. There is increased competition for trial participants—a cohort that necessarily includes both males and females with a range of skin tones. There is even increased competition for comparative products, which need to be matched by mechanism of action and intended use. Those challenges compound the normal concerns of data integrity, robust endpoint analysis, and hewing to the trial schedule. With all these strictures, the expertise of an experienced partner can make the difference between success and failure.
To learn more about how Premier Research can help you at every step of your next study, contact us.
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