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Dermal Filler CRO

We are experts in dermal fillers, with a proven track record of FDA Premarket Approvals.

When selecting a CRO for a North American study, you should prioritize FDA experience, demographic understanding, photographic validation skills, and a history of success with innovative, durable dermal fillers. ethica CRO ensures compliance and aligns with the medical aesthetics industry’s push towards sustainable, high-quality solutions that meet diverse population needs.

ethica CRO is highly experienced in the following areas:

Successful FDA Track Record

Decades of filler experience equals invaluable insights into FDA expectations.

Research Participant Diversity

We excel in diverse research participant recruitment ensuring compliance and inclusivity

Innovative Filler Technology

Our HRPP as a proven risk management strategy for innovative filler technologies

Discover how our clinical expertise can benefit your dermal filler study

Our dermatology CRO specializes in mitigating dermal filler risks—bruising, swelling, infections, and notably, vascular occlusion, a rare but serious event. Through its Human Research Protection Program, ethica focuses on identifying, assessing, and mitigating these risks by implementing meticulous study designs, providing comprehensive investigator training, and conducting continuous monitoring for adverse events.

This strategic approach by ethica ensures the maximization of potential benefits while minimizing risks to research participants, safeguarding the integrity of research and participant well-being

Our expertise for dermal filler clinical trials

At ethica CRO, we have accumulated extensive experience in every facet of dermal filler research. From protocol development and meticulous setup of study logistics to site management, monitoring, data management, biostatistics, and Clinical Study Report (CSR) development, we provide a comprehensive suite of CRO services. Our track record showcases our ability to deliver excellence across the spectrum of dermal filler research and development. Some of these include:

Pivotal IDE

Through our expertise with pivotal IDE research, we produced data that supported our clients’ dermal filler premarket approvals by the FDA for several indications including nasolabial folds (NLFs) and lip augmentation to perioral rhytids and midface volume deficits. Our expertise also extends to investigating techniques, including needle vs. cannula usage, and handling emerging issues like a sagging jawline, acne scars, and the comparison of anesthetic formulations for your complete dermal filler solutions.

Medical Affairs

We conducted extensive medical affairs research exploring dermal fillers for applications like lip augmentation, midfacial atrophy, and filler/toxin combinations, focusing on consumer insights and product development. Our research services involved understanding patient demographics, preferences, and satisfaction to guide innovation in formulations, application techniques, and safety. By aligning these findings with emerging needs and trends, ethica CRO contributed to the development of advanced fillers.

Exploratory Research

We can explore through research projects new products and administration methods. We conducted first-in-human safety and feasibility studies, paving the way for innovative dermal filler solutions. Our expertise extends to combining fillers with microneedling and laser treatments, providing effective, evidence-based options. We also have broad in histological exploration to understand tissue responses to dermal filler injections

Complex trial resolution for data enhancement

ethica has expertly conducted rescue studies for mismanaged dermal filler trials, including re-analysis of data and re-writing clinical study reports to realign study data to respond to FDA’s requirements resulting in successful PMAs.

Case Study: FDA’s First Approval of a Dermal Filler for the Treatment of Acne Scars

It is estimated that between 40 and 50 million people in the U.S. currently suffer from acne. Approximately 95% of acne patients are affected by permanent textural changes, scarring, and skin indentations that occur as a result of acne. Acne scarring, whether it is moderate or severe, can significantly impact the well-being and quality of life of acne patients.

ethica CRO successfully designed and managed a double-blinded, randomized, placebo-controlled pivotal study that led to the FDA’s first approval of a dermal filler for the treatment of acne scars.

Designing and managing filler studies for nasolabial folds, lip augmentation or cheek volumization is quite straightforward; however, there were no predicate filler studies of acne scars.

A proprietary assessment scale was developed, as there was no validated scale for assessing the severity of individual acne scars. An innovative photography rig was also created to effectively and consistently produce photos that captured depth of individual scars.

There was a heterogeneous distribution of acne scarring amongst eligible research participants with the number of scars per participant ranging from approximately 4 to 25. ethica created the full statistical analysis plan (SAP) to include generalized estimating equation (GEE) cumulative logit models and appropriate sensitivity testing (e.g., tipping point analyses) to address the unique presentation of acne scarring.

ethica’s accredited procedures, clinical trial project management processes, and trial master file (TMF) were audited by the FDA with no 483s issued. Following product approval, ethica assisted its client in their medical affairs research program.