Validated skincare claims: Insights on proving efficacy with in-vivo testing

in-cosmetics Groupby in-cosmetics Group

In Featured, Ingredients, Ingredients & Formulation.

Validated skincare claims: Insights on proving efficacy with in-vivo testing

Validated Claim Support

(Sponsored Content)

In this exclusive interview, we caught up with Brian Ecclefield, the Founder of  Validated Claim Support, who shares his thoughts and insights into the testing market, harmoniziation and disruptive trends as well as a secret very few people know…

Sunscreen is exploding currently. Can you share some insights into what is going on in the field, especially with regards to testing and perhaps the role retailers and influencers are playing?

Exploding is a great adjective here, as that is exactly what sunscreen is doing at the moment.  There are numerous articles regarding underperforming sunscreens on the market, and social media is volatile with back and forth assertations and allegations.  

The global market has had a major push towards “Mineral Sunscreens” which means those which contain only Zinc Oxide and Titanium Dioxide.  “Organic SPF Filters” have been somewhat vilified in a variety of markets due to their potential for degradation and interaction with the human body and the environment as a whole (as an easy example think “Reef Safe”).  

From a chemistry perspective, “Organic” or “Chemical” sunscreen filters are extremely effective and often backed by decades of bioavailability and safety studies at the global level.  Zinc and Titanium tend to have a fairly limited “efficacy range,” and only in the best formulations at extremely high quantities can the two ingredients successfully achieve water resistant SPF 50+ results. 

That said, they seem to be the two ingredients that find their way into the newest formulations, particularly within the US Market which has extremely limited filter choices due to FDA (over) regulation of the space.

With so much regulatory scrutiny and consumer skepticism, what does the future hold for cosmetic claims? Global harmonization in claims acceptability?

The market at large is currently “adapting” to push the boundaries of these “mineral” filters as far as possible, and that is often being done with “SPF Boosters” such as Butyloctyl Salicylate (BOS).

SPF Boosters are “quasi-regulated” and they do not have to appear in the “Active Ingredients” section of a sunscreen’s label despite the fact that they have a clear and direct impact upon the final SPF (the same formula with and without BOS will have a higher SPF once the BOS is added). 

Until regulatory can catch up with the “booster trend” consumers need to stay wary of “100% Mineral” SPF Label Claims, as they may be misleading since there are non mineral ingredients impacting the formula.  Chemically, BOS is very similar to Octisalate, which is an approved SPF active ingredient in most markets.

Regulatory needs to make decisions as to “inactive ingredients that are impacting the formulations performance” (which sounds to me like the definition of an “Active Ingredient!!!!!”). 

Unfortunately this will likely not be done in a “harmonized” manner as you have noted.  The EU and the US tend to go their own ways on Sunscreen and Cosmetic Regulation, and for a while with the MoCRA initiative in the US it looked like we could have moved towards some harmonization, however the current administration is in the process of “doing something serious” at the FDA. 

I think a good place to start would be “action” in the local regulatory zones which is decisive and complete.  As an example – ISO is working towards new international standards for hybrid in vivo/in vitro SPF results.  This would be a huge boon for consumer safety and testing ethics as participants would be receiving 95% or more of a reduction in delivered radiation during the efficacy/performance tests.  
 

In your opinion, what disruptive trends or technology in efficacy will render today’s methodology obsolete five or ten years down the line? 

I just mentioned the “Hybrid SPF Testing” element, which is fully known as Hybrid Diffuse Reflectance Spectroscopy or HDRS.  Without getting into the deep science, this method will allow a much faster and safer SPF evaluation that doesn’t require directly sunburning the participants.  

This method is going to absolutely revolutionise clinical testing and claims, as for the first time it directly combines both in vivo UVB considerations as well as combining the reflectance technique which will provide insights that can’t be recognized through changes of the skin alone.  

This new method could* lead to the harmonization that you alluded to in question 3 – if we can get a formal, adopted, and approved method through ISO and FDA it will revolutionise the industry, making these tests faster and more efficient.  It will take away a lot of the variables that make the current test models so difficult, as there is no longer going to be a “subjective” assessment of the redness in the skin.  

Sunscreen testing will be utterly revolutionised – and it will actually become a much easier test to implement.  This will open up the competition and allow more players to compete in a healthy manner within the extremely niche claims and efficacy space, and it will also allow brands to conduct more of their own internal preliminary pilot research.


Can you share a secret about cosmetic testing very few people know?

Suncreen testing involves actively dosing people with UV radiation to a point where you illicit a redness response on the skin of the back.  Dumbing that down – it requires lightly sunburning 10 (and often more) people at a time.

These people also have to have a fair complexion, so sunscreen testing in upon itself is often only done on light skinned individuals.  If you see a product with an SPF that says it was “tested on all skintypes” it is definitely not talking about Fitzpatrick types, at least as far as the direct SPF efficacy is concerned.

A related one based on the above – “tested on all skintypes” OR “suitable for all skintypes” can actually mean 2 very different things.  It can mean that a product is tested on all of the Fitzpatrick skintypes, with Skintype I being the lightest and Skintype VI being the darkest, but it can also mean it is tested on a population where at least some of the individuals identify as “oily, dry, and/or combination skin.” 
 
This is a very common claim, and it’s  just about impossible to determine what categorization of “skin types” that the brand is referring to regarding the specific product data without having the test results in hand.


About our Interviewee: Brian Ecclefield, Founder, Validated Claim Support

Brian Ecclefield

Brian has spent the last 17 years custom developing in vivo clinical studies to help international brands build their personal care and cosmetic product portfolios. 

In 2018, he founded Validated Claim Support in the Testing, Inspection, Certification, and Compliance (TICC) space as an alternative to the “CRO Status Quo,” offering an ethical, transparent, and technologically secured solution for the modern Personal Care manufacturer.

Brian is heavily involved with consumer education and protection as it pertains to product label claims.  He has helped poke holes in misguided marketing language as an Expert Witness for cosmetic ingredients. 

By ensuring that end users gain a better understanding about what cosmetic and personal care claims actually mean and the value of doing studies the right way, Brian hopes to help make skincare clinical testing more transparent and CROs more accountable – leaving the industry a safer place for everyone.


Validated specializes in 4 main types of clinical testing to support claims:

  • Expert Objective Clinical Grading
  • Subjective User Perception
  • Biophysical Instrumentation
  • Clinical Before and After Photography

Onto the product/service we provide:

Validated Claim Support is a Skincare Clinical Testing Laboratory that conducts in-vivo (consumer/human) studies to determine how well products work.  We are decidedly “clinically” focused – we don’t do stand alone at home consumer perception studies, and our expertise is measurable endpoints – think clinical studies where participants, not @ home user consumer perception.

We conduct Expert Grading of visible changes in the skin and hair, biophysical instrumentation for things like hydration via electroconductivity, skin firmness and elasticity, surface sebum content, skin colour, skin texture, fine lines and wrinkles, and a wide range of other endpoint as well.

We test skincare, medical devices, OTC level ingredients, and a wide range of cosmetics (we also get into nutraceuticals but that’s less directly relevant). We’re FDA Registered and Inspected, and we ran over 70 completely custom clinical studies last year – many of which were for brands who you’ve already hosted. 

I founded VCS in 2018 as an “Alternative to the CRO (Clinical Research Organization) Status Quo” after having left two different laboratories over what I’ll call “unreconcilable ethical differences,” which proved to be extremely well founded. 

The owners of both companies have been in international news for fraud, and from my perspective, there is a very good reason.  I can tell you this, with 100% certainty. . . Skincare claims data that looks too good to be true is most definitely too good to be true!  That’s not to say that there aren’t highly effective products out there, but nothing is 100% effective 100% of the time.  This is a whole exciting topic in upon itself, and I’d be happy to chat more about it at a later time. 

Find out more about Validated Claim Support here

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