One of my favourite things to do is search through tens of hundreds of skin trials to try and establish some truth in what I hear in the media. So, you can imagine my excitement when I stumbled upon a Podcast episode on Goop with the controversial title “How Science is Manipulated.” It’s worth a listen, and it opened my mind to a world of clinical trials. In this blog post you get to see the collective notes from my mission to distinguish how clinical trials, especially skincare trials are carried out, and the effect it has on us, as the consumer, as we perceive a skincare product in front of us.
What is the purpose of a clinical trial?
Clinical trials are set up and carried out to test a new formula, product or device. This helps healthcare professionals:
Understand how to treat or manage symptoms related to a particular illness or condition
Answer questions about new therapies and ideas, vaccines and diagnostic procedures
Measure safety and efficiency of existing methods
Have a better insight on how to offer physiological support to patients
Clinical trials, whether it is to test a new skincare ingredient or new drug, can take years to carry out. Some trials are not even completed due to shortage of participants – the risk of potential side effects or not offering any benefit at all, taking time off work, the length of time it takes, and the cost involved can all contribute to a lack of contributors.
Who takes part?
Doctors, nurses, patients and volunteers, researchers, representatives from pharmaceutical companies and trial managers all contribute to these trials.
Patients may be approached to trial a new treatment if an existing method proves ineffective for them. Volunteers are chosen upon a set eligibility criterion, paid in small to much larger amounts, whereas others have only immediate expenses paid. Be Part of Research, World Health Organisation. and Charities like Cancer Research and Multiple Sclerosis Society provide more information to the public on how you can take part, on their websites.
Who funds clinical trials?
Clinical trials are complex to carry out and have drastically increased in cost by 100%, from 2008 to 2019 according to Tomasz Sablinksi, CEO at Transparency Life Sciences.
Cost of treatments, procedures and testing, wages for the research staff taking part and administrative costs all have to be covered and there are a variety of different organisations and institutions that fund such trials. The funders can also be referred to as the “sponsor” of the trial. For medicine and health treatment, these can include:
The Government (The Medical Research Council & National Institute for Health Research)
What is the process of a clinical trial? Once the team of researchers, test patients and other necessary staff have been recruited, there are four official phases to a clinical trial.
Phase 1) This involves testing the new medicine/device on a small number of people. The doses of the drug are modified depending on the side effects from the test patients.
Phase 2) The new medicine is tested on a larger group of people, usually with a particular condition that needs to be treated or managed.
Phase 3) The new medicine is tested on even larger groups of people, up to several thousand, and compared to an existing or placebo treatment for a year, maybe longer.
Phase 4) The new medicine continues to be studied. Licenses are sought after during this time to make it available on prescription or to the direct market.
There are various trial designs and terms to describe each one. If you are familiar with reading clinical trials, you would have most likely heard of these before.
Controlled trials compare an existing medicine or treatment with a new one. The ‘control group’ uses the existing treatment whilst the ‘trial’ or ‘intervention group’ tests the new one.
Blind trials refer to a study where the participants do not know if they are in a control group or the trial group.
Double-blind trials are when the doctors don’t know what group they are evaluating either.
Randomised or Crossover trials allocate participants into their treatment groups at random.
Blind and randomised measures are put into place to help diminish any potential biasness, making the trial as fair as possible.
How cosmetic trials and testing works
For cosmetic trials, the process looks a little different. The Food and Drug Administration (FDA) defines cosmetics as:
"articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance without affecting the body's structure or functions."
The School of Natural Skincare explains the requirements for selling such products, and how it differs depending on the formulation.
Products that don’t contain water such as balms, oils and serums do not require preservatives and therefore are the easiest and quickest product types to be tested. Water-based products are more expensive to test as they are more prone to bacterial growth.
Although it is recommended, some countries don’t even require legal testing of cosmetics and skincare before they are released to market. In the UK, The School of Natural Skincare explain that the following tests are required for cosmetics:
1) Preservative efficacy testing (PET) is required for all products containing water to ensure the microbial stability of the product. It takes a minimum of 28 days and costs from £150 to US $500.
2) Stability testing is recommended for all products to trial the chemical stability, determine storage conditions and the shelf life of the product. For a product that expires after 12 months, it takes at least two months to prove this theory. Prices start from £185 to US $1200
3) A Cosmetic Product Safety Report has to be carried out when the product is being sold in the European Union (EU). This report requires the results from stability and PET testing to complete the assessment. The cost of a CPSR starts from £30 and the time it takes depends on the assessor.
There are other tests that can be carried out to enhance the credibility of a product and boost profits. These two common claims are:
This means the product was tested on humans under the supervision of a dermatologist.
This refers to a product being tested on humans under the supervision of a medically-qualified professional in a clinical setting.
Why dermatology and clinical tests matter for cosmetics
If a brand is making a certain claim about a product (such as improving skin texture, colour or hydration) they have to provide some kind of evidence to back up this claim. This is where these kinds of tests come in.
Clinical testing for cosmetic products can be just as expensive and take up as much time as developing a new medical drug or treatment. With great expense, comes great risk. The results may not be usable in marketing campaigns. Some trials can take years. Skinceutical’s antioxidant CE Ferulic famously took 40 years of academic research to develop.
There is controversy amongst these claims of dermatologically and clinically-tested products as we cannot ignore the conflict of interest between the ‘expert’ and the money they make from backing up such claims. Many of these experts are not scientists, or have any expertise in cosmetic formulation however, they still remain a useful and constant tool in the art of marketing an upcoming skincare product.
If a skincare product is dermatologically or clinically tested it doesn’t necessarily limit the chances of a reaction, but enhances the probability of a product working a specific skin type.
For all these reasons, this is why putting the ‘dermatologically-tested’ or clinically-tested label to a product is perceived attractive to use in marketing campaigns.
Brands loyalty VS Skincare trials
In some cases, established brands do not have to push for, or rely on clinical data to sell their products. Take KylieSkin for example. The owner of one of the most talked about skincare brands on the planet, Kylie Jenner, does not need statistics and fancy ingredients to sell her products successfully. In fact, I couldn’t actually find any evidence of the results from her trial in the same way medical-grade skincare companies offer. People will buy from her anyway, even if they don’t necessarily support her as a person or see results with her products.
Glossier is another great example of this. Glossier is in fact ‘dermatologically-tested' and cleverly offers the “full clinical trial” to most of their products on their website. Still, there are some technical questions to be raised.
Glossier’s famous Super Bounce was tested on only 30 women. The evaluator graded “visual brightness” and the 30 women (where are the men?) evaluated the mystery product through a self-perception questionnaire. Where are the before and after photos? Why were only 30 women used? Did they have normal, non-problematic skin types? What questions were they asked? How did they grade their self-perceived results? The point I am trying to make is that none of these questions are ever really raised by the consumer, or have to be answered due to Glossier’s flawless ability to gather a cult following through targeted, mass marketing.
This is the same reason so many aesthetician’s and other industry professionals are working on self-branding harder than they have ever done before. Branding works for business. Especially now, more than ever before, people are curious about the goings-on and personal recommendations from the industry before making their purchase. The beauty and aesthetics industry becoming so saturated with workers in recent years, and the most successful are those building glamorous representations around their working environment.
How do we, the consumer, know what we want to buy? Do we just decide one day, or does somebody tell us? People want to feel like they are buying a lifestyle, a feeling from the person that is selling it to them. Buyers are less likely to question the efficacy of a product when it is recommended by a person that works around skincare and treats skin conditions. Creating strong brand loyalty can be fiercer and sometimes, evidently more effective than promoting the results of a clinical trial.
Did you find this post useful? Then you will love learning about how skin expiration dates work here.