As the beauty and wellness industries continue to grow, and scientific advances decrease the speed of new product development, standing out is vital. One way to catch the eye of discerning consumers is with clinical testing.
Clinical testing allows for marketers to make strong, substantiated efficacy claims, often alongside dynamic before-and-after imagery. However, clinical testing can be expensive and time-consuming, often adding tens of thousands of dollars and months of work onto the budget and timeline to bring a product to market. For brands that invest, clinical testing can boost brand reputation and consumer confidence.
However, skeptics argue that consumers have trouble differentiating between clinical testing and consumer perception testing, which requires a fraction of the investment. Experts break down these topics and their pros and cons ahead.
What is clinical testing?
Clinical testing refers to product testing done on humans in a tightly regulated, scientific setting using advanced measurement technology. This includes precise photography done in a lab and data collection using a variety of instruments that can measure tiny changes in skin hydration, sebum production, wrinkle depth, pigment, redness, inflammation, skin texture and more attributes throughout the study.
Clinical testing is often done on dozens of subjects for several weeks to months, commonly 12 -16 weeks, using the finished product. This testing can cost anywhere between $25,000 and $40,000 per product tested, according to Lisa Mattam, founder and CEO of clinically-tested Canadian skin-care line Sahajan.
Is lab sample packaging acceptable for a clinical study?
In some cases, yes. If the instructions call for a “pea-sized amount used daily,” then any packaging should suffice, according to Laura Lam-Phaure, founder of Lam Phaure Beauty, a firm that specializes in technical product development and custom formulations. However, if instructions call for “two pumps of product used daily,” then the product must be in its final packaging to ensure accurate dosing.
While not necessarily required, Lam-Phaure recommends using final packaging across the board to ensure any issues that arise with the final product can be caught. “The packaging really should be 100% done, it just shouldn’t have any artwork printed on it,” Lam-Phaure said.
Label-less packaging prevents information from being leaked online about the product, and any bias against the brand or product name by the tester. It also protects the brand’s reputation if the product performs poorly.
What are the risks and benefits of clinical testing?
Perhaps the biggest risk in clinical testing is financial: If the product doesn’t yield the results a brand is looking for, its monetary investment is basically lost. However, Mattam told Glossy that a brand should be incredibly confident that it will do well before signing up. Few brands are making a shot in the dark at this point in the NPD journey.
“There is always a risk,” Mattam told Glossy. “One of the bigger challenges [in NPD] is being able to understand where and when to invest.”
However, Mattam told Glossy that a brand should have a good idea of how the product will do based on internal testing and existing data on efficacy, which is normally provided by the ingredient manufacturer.
Brand reputation, however, is not a risk since participants are not aware of the product name or brand.
Another benefit of clinical studies is peer-reviewed findings, which undergo vigorous review by experts like dermatologists, pharmacists and/or clinical statisticians. Because of this, these results are considered some of the strongest a brand can have, meaning they hold up to legal scrutiny and give markets better confidence in promoting the results of a product.
How do you pick a clinical testing facility?
This can be handled internally at a brand or through one’s manufacturer. Internally, this is normally handled by a brand’s regulatory department with help from NPD or R&D. Or, it can be overseen by a brand’s contract manufacturer, Lam-Phaure told Glossy.
“Honestly, almost every cosmetics testing lab will have these types of tests available,” Lam-Phaure said. “So I simply reach out with the specific protocol I need [for a specific product], and I use the one that’s the cheapest one.”
It’s important to note that for products considered OTC drugs by the Food and Drug Administration, like sunscreen or acne products with certain ingredients, manufacturing and testing requirements are different and require special certification from FDA.
Selecting a lab is nuanced, and a strong relationship can go far, said Lam-Phaure.
For example, one lab she works with provides updates through a study to ensure results are heading the way the brand wants. “If [the study] is not doing well, we can cut it off and get a little money back,” she said. For example, by the fourth week of an eight-week consumer perception study, the lab is likely to be very clear which way it’s going.
What other types of testing should be done on beauty and wellness products?
Whereas clinical testing is optional for brands — and often done when budget and marketing endeavors allow — there are several tests that should be completed before a new product can enter the market, Lam-Phaure told Glossy. This includes safety and stability testing, which test for potential skin irritation and shelf life, as well as microbial and compatibility testing, which test for bacteria growth potential and stability in the formula’s final packaging.
Stability and compatibility testing are where brands fail the most, Lam-Phaure told Glossy. Much of this comes back to the influx of recycled materials used in packaging, which are less predictable than virgin materials.
“A high percentage of PCR content [post consumer resin] can cause issues with [the stability of] formulas, so sometimes you have to reformulate,” Lam-Phaure said. “The government, especially New York and California, want us to use more PCR, … but PCR is the enemy of the chemist.”
Some brands also opt for heavy metal testing and other contaminant testing that tests for manufacturing byproducts like benzene or 1,4-dioxane, both of which have garnered headlines over the past few years.
Testing for claims like “ophthalmologist- or dermatologist-approved,” “non-comedogenic,” or “safe for sensitive skin” often start with third-party groups like the American Academy of Dermatology or The National Eczema Association. As previously reported by Glossy, many groups offer certifications for brands that independently complete a specific list of tests and pay associated membership fees. These groups offer their own seals, which can be displayed on websites and product packaging.
Does FDA require certain tests on beauty and wellness products?
The FDA does not require specific tests for regulatory compliance under MoCRA. However, the law does require that brands “ensure and maintain records supporting adequate safety substantiation of their cosmetic products,” according to the FDA. “Manufacturers can use relevant safety data that is already available to support the safety of their products. … It’s important, however, that all data used to support the safety are derived from scientifically robust methods.”
In layman’s terms, the FDA doesn’t monitor these tests, but if a consumer reports an adverse reaction to a product to the FDA, the brand and manufacturer must prove the product was properly tested for safety.
Many retailers have their own set of standards, and many require a certificate of analysis, often called a COA or C of A, which provides test results and facilities where they were performed.
Where does eye safety testing fit in?
If a product is meant to be used near the eyes or on the eyelids, an eye safety test must also be completed. Many brands opt to have this testing done on all color cosmetics, like blush or lip color, to give the marketing team the flexibility of using them on or near the eyes in marketing materials.
For example, if a cream blush or lipstick is released without eye safety testing, the brand could face legal trouble if it’s applied near the eyelids in a creative photoshoot used in marketing materials. To give artists and creators creative flexibility, many brands test for eye safety across their collections.
Does clinical testing differ from consumer perception testing?
Yes, clinical testing is very different from consumer perception testing, although many consumers cannot tell the difference, according to the experts Glossy spoke to.
Whereas clinical testing is done using scientific processes that measure changes with precision, a consumer perception test asks testers to take a product home, use it for a specific amount of time — often four to eight weeks — and then self-report their findings. Instead of measuring results, they collect how consumers think or feel about a product.
This can be independently done by a brand, without the high costs of a lab, but leaves brands more open to legal scrutiny, so all verbiage around results should be highly scrutinized internally before sharing with the public. Mattam told Glossy that, in her experience, consumer perception tests cost about a quarter of the cost of a clinical study.
This is a great way to substantiate claims while keeping costs low. For example, if a brand wants to claim a serum makes skin feel softer or appear radiant, a consumer perception study could suffice. If a brand wants to make a claim that a serum boosts hydration by 90% or reduces fine lines in four weeks, clinical studies would be necessary.
“If you’re going to claim literally anything, you need to substantiate it [one way or another],” Lam-Phaure told Glossy.
However, either testing method can be valuable not only for a brand’s marketing endeavors but also for gauging how consumers will likely react to a new product. For example, if nearly all testers felt their skin was softer or more hydrated, whether through perception or clinical studies, then it’s quite likely that’s how consumers will also respond, which helps brands manage launch feedback expectations.
