Whether they are insight-based or straight from a wide-net test, clinical claims are generally shaped according to certain standards. Industry conventions dictate specific language when reporting results, controlled partly by good clinical practices (GCP) and regulatory compliance. The language that should be used to report a clinical grade improvement differs from the language that should be used to signify a subjective agreement that an improvement is noticeable. In addition, magnitude and incidence of improvement both generate numbers, usually very different, and using them interchangeably is misleading.

Unfortunately, consumers have not been educated on these standards and have no way to discern magnitude from incidence or what signifies objective vs subjective. Here’s a primer to help decipher the true source of the claim number and therefore the claim strength, using fictitious numbers and pigmentation as a clinical endpoint for illustration purposes.

Clinical Magnitude

Example: 30% improvement in pigmentation. Magnitude numbers reflect the average percentage of clinical improvement observed across the panel of subjects. In consumer language, they signify the level of efficacy she can expect from the product. They are typically not the highest, because they are the hardest ones for which to achieve significance. For this reason, they may not be chosen by the brand to represent the product, which is regrettable, because they are a strong indicator of efficacy. Whether they rely on the trained eye of a clinician or a bio-instrument, magnitude numbers are an objective measurement of true efficacy, and together with before-and-after pictures, paint a powerful portrait of the benefit delivered by the product as perceived by someone other than the consumer.

Clinical Incidence

Example: 92% of subjects show improvement in pigmentation. Incidence numbers reflect the percentage of the panel that showed clinical improvement in the study. In consumer language, they signify the odds that she will benefit from the product. These numbers tend to be higher than magnitude numbers and thus are often used on labels or marketing materials. They should not be confused with magnitude numbers; unfortunately, 92% of subjects show improvement often becomes abbreviated into 92% improvement, misleading consumers into believing that this high number represents the efficacy level to be expected (the magnitude of the effect). It is always wise to remain skeptical in the face of sky-high magnitude numbers, as they may be incidence numbers in disguise.

Subject Assessment Questions (SAQs)

Example: 80% agree that their skin tone is more even—80% saw their dark spot fade. Of all numbers, SAQ numbers are the most popular for claims. This is because they are the product of curated questions and tend to be highly descriptive and focused on consumer-perceivable benefits. The trouble with SAQs claims is that high numbers can be obtained with leading questions; these claims are therefore not only not objective but also potentially contrived/predetermined. On the other hand, they can ultimately describe what the consumer will see and how the product will make her feel, so they can be powerful in their own right.

Data shows that claim skepticism from consumers is rising, partly because so many of these claims have been incorrectly supported in the past, and partly because consumers are more knowledgeable about ingredients and tend to draw conclusions about the product for themselves. But this, too, is a slippery slope, as the ingredient listed on the label says little about its level in the product, and nothing at all about the vehicle it is placed in; both determine the product’s safety and efficacy profile. New regulations (MoCRA) would help with claim substantiation transparency, and much work remains to be done with ingredient scientific communication.

About the Author

Laurence Dryer, PhD is a co-founder of Skin Sage Advisors. The private consulting firm offers strategic, scientific and operational expertise to help private equity and brands navigate the complex world of skincare, domestically and internationally. Dryer’s expertise is founded on her prestigious academic career in neuroscience and cemented by her R&D tenures at J&J, The Honest Company and BASF Beauty. Later, at Valeant, Obagi and Clinical Skin, she led scientific, regulatory, clinical and product development strategies. Dryer specializes in scouting innovation, developing and characterizing products, and making science accessible through impactful content. She has dozens of publications and patents.

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