How can I assess the effectiveness and safety of an Aroma-Zone product?




Assessing the safety* and efficacy of a cosmetic product is a delicate step, taken at a very early stage in its development.

  • It must meet the strict requirements of cosmetics regulations [1] in terms of product safety, which aim to ensure that all cosmetic products on the market are safe for users.

  • It must incorporate active ingredients in sometimes high concentrations, and guarantee good local and systemic tolerance under the intended conditions of use. For example, our hyaluronic acid serum has been tested on the skin for its anti-ageing and moisturising properties, and on the hair for its protective properties.

  • Lastly, it must be adapted to a wide range of individual needs, to different skin types, with varying degrees of sensitivity and reactivity.

Assessing the safety of a cosmetic before it is put on the market is therefore a major challenge for Aroma-Zone's Research & Development teams. In addition to the efficacy of a cosmetic product, its safety* must be carefully analysed. Aroma-Zone takes up this challenge every day, with each new product formulation, in order to guarantee the safety and protection of its consumers.



Guaranteeing maximum safety and efficiency


Adeline Nalin, Regulatory and Toxicology Manager Pharmacist at Aroma-Zone, explains.


"Guaranteeing maximum safety and efficacy is our priority when developing our products. To achieve this, we draw on specific in-house expertise, and incorporate the latest innovative in vitro methods coupled with clinical tests on panels of volunteers."



What tests are used during product development?

At Aroma-Zone, numerous tolerance and efficacy tests are performed from the earliest development stages.

1. Tests on reconstructed skin models at Aroma-Zone Laboratoires

These are innovative and advanced tests that reproduce human skin in vitro, with the same layers of skin (the stratum corneum and the first layers of the dermis). Reconstructed skin models are an effective method for ensuring the safety of our cosmetics without resorting to animal testing.

They are used to test a cosmetic product for corrosivity, phototoxicity, genotoxicity, skin irritation, or eye irritation. The rigour of these tests is comparable to that applied in pharmaceutical studies. This method is also used to test medical devices. Given their high concentrations of active ingredients, our serums are systematically tested on this model from the very first stages of development.


2. External clinical tests

These tests are generally conducted on a carefully selected and randomised panel of volunteers (between 20 and 40 participants) who correspond to the criteria of the target population (skin type, sensitivity, age, etc.).

They are performed by independent testing laboratories, under the supervision of a healthcare professional (such as a dermatologist, ophthalmologist, or paediatrician), in order to obtain the most objective and unbiased results possible.

Our clinical tests are conducted under normal conditions over a 28-day period (compared with 21 days in most laboratories). Aroma-Zone has chosen this longer duration in order to take into account the influences of the menstrual and hormonal cycles and to cover a full skin cell renewal cycle.

These tests enable us to collect:

  • Local tolerance data (clinical signs confirmed by a dermatologist and feelings of discomfort reported by volunteers) : this ensures that the product tested is perfectly tolerated by a representative sample of the target population.

  • Declarative efficacy data: this consists of declarative feedback from volunteers on the observed efficacy of the product, via a questionnaire.

  • Instrumental efficacy data: efficacy parameters are also measured using specific instruments. For example, a corneometer is used to measure skin hydration (before/after application of the product) or a cutometer to measure skin elasticity (before/after application of the product).

An innovative and complementary in vitro method, developed by Aroma-Zone, to assess the irritation potential of serums

On 14 and 15 November 2024, Aroma Zone attended the annual congress of the Société Française de Toxicologie in Lyon to present its R&D work: a reconstructed human epidermis to assess the potential for irritation in the development phases of serums at the Aroma-Zone laboratories.

Its name is the AlternaSkin® model.

This model has a structure and physiological characteristics close to those of human skin. It can therefore be used to assess the primary irritation potential of Aroma-Zone cosmetic products under real-life exposure conditions [2], [3]. Non-invasive and certified vegan, it gives our brand a considerable advantage.

How does it work?

The irritant potential of the product tested is assessed using:

  • Cell viability: do the ingredients used cause degradation of the cells in the AlternaSkin reconstructed skin model?

  • The expression level of key cellular markers of inflammation: does applying the serum cause inflammation of the cells in the AlternaSkin reconstructed skin model?

What is the point of this scientific innovation?

Aroma-Zone sees 4 major benefits in using AlternaSkin in vitro models as part of their product development phase. They make it possible for us to

  1. Quickly and effectively decide on the choice of preservatives (or the combination of other ingredients) in Aroma-Zone serum formulations. Get an in-depth understanding of how formulas behave.

  2. Obtain reproducible and robust results!

  3. Reproduce the different morphologies and characteristics of human skin as well as the real conditions of exposure to a cosmetic product using non-invasive methods.

  4. Validate a formulation using a technical and scientific approach to tolerance, and to supplement the clinical tests carried out at a later stage.

A spotlight on the annual congress of the Société Française de Toxicologie

Aroma-Zone is proud to have been selected by the SFT jury to present its scientific poster at the annual congress of the Société Française de Toxicologie, which took place in Lyon on 14 & 15 November 2024.


Aroma-Zone and its partner Cell Alternativ were able to present their work on Alternaskin, a reconstructed human epidermis to assess the potential for irritation during the serum development phases at Aroma-Zone laboratories.

This innovation is a perfect illustration of the exacting standards, rigour and expertise of our Research & Development teams.

* Quality that is not harmful.



Sources

[1] Regulation (EC) N° 1223/2009 of the European Parliament and the Council of 30 November 2009 on cosmetic products.

[2] Poumay, Y., et al, (2004) A simple reconstructed human epidermis: preparation of the culture model and utilization in in vitro studies. Arch. Dermatol. Res. 296: 203-211.

[3] Roguet et al, Use of the standardized reconstructed epidermis kit to assess in vitro the tolerance and the e cacy of cosmetics, International journal of Cosmetic Science, 22: 409-419, 2000