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Meeting Unique Technical Challenges: The Case of FDA’s First Approval of a Dermal Filler for the Treatment of Acne Scars

Executive Summary

Acne is the most common skin disorder in the U.S. affecting 40-50 million people. Up to 95% of people with acne may go on to suffer from scarring. Acne scarring can have significant impact on well-being and quality of life, particularly for people with moderate to severe acne scarring.

A US aesthetics company wanted to expand the indication of its dermal filler to include the treatment of acne scars. Through a competitive bidding process, ethica submitted the most cost-effective full-service proposal (i.e., protocol development, study management, study monitoring, data management, biostatistics, statistical analysis plan (SAP) and clinical study report (CSR) development) and was awarded the contract.

ethica then proceeded to successfully design and manage a double-blinded, randomized, placebo-controlled pivotal Investigational Device Exemption (IDE) study that led to the FDA’s first approval of a dermal filler for the treatment of acne scars.

About the Client

The client is a privately-held company focused on developing, manufacturing and commercializing aesthetic products.

The Challenge

Research into novel indications is typically met with unique technical challenges. 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.

The Solution

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 created to effectively and consistently produce photos that captured depth of individual scars and an Independent Photography Review Panel was created to verify live assessments conducted by Investigators.

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.

Importantly, site management and monitoring strategies were employed to ensure appropriate site training on injection techniques, scar assessments, and participantenrolment/randomization/retention.

The Results

ethica 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. 175 research participants were recruited at 10 dermatological research sites across the United States of America. ethica’s accredited procedures, study management processes, and trial master file (TMF) were audited by the FDA with no 483s issued. Following product approval, ethica assisted the Client in their medical affairs research program.

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