FOR YOUR SAFETY: A STRICT DEVELOPMENT CHARTER

Your trust, rooted in the guarantee that all our products are safe, is essential. This is why, for over 50 years, evaluating the safety of our products has involved 3 types of analysis conducted with extreme rigor.

For your safety, we have developed a strict dermo-cosmetics development charter

Faced with a flood of contradictory information and warnings
coming from all angles—with varying degrees of reliability—it is difficult to separate the truth
from the lies
, and to know what's really good for our health.
At Ducray, we believe that the best way to reassure you is to provide you with all the information
you need
about the composition and monitoring of our products, so that you can decide for yourselves.
Your trust is just as precious to us
as your skin or your safety. This is why, every day we do everything we can to offer products
about which we are 100% sure.


 



While developing our formulas, if we encounter the slightest problem during these tests, the response is categorical: the product is not put to market; it's back to the drawing board. For DUCRAY safety comes first. Each of our products is therefore marketed with the absolute guarantee that it is safe to use under normal conditions.

 

A word from our expert: Pierre-Jacques Ferret, Director of Toxicology and Cosmetovigilance at Pierre Fabre Dermo-Cosmétique

 

"How do you develop safe products?"

« "Our consumers' trust, rooted in the guarantee that all our products are safe, is essential.
This is why, for over 50 years, evaluating the safety of our products has involved 3 types of analysis conducted with extreme rigor."
Guaranteeing the safety and innocuousness of all our products entails a strict inspection process: :

A Ducray product can only be marketed if all the following steps are completed and if the results are satisfactory.
This approach from the Pierre Fabre group applies to DUCRAY, but also to all of the group's other brands.

 


OUR APPROACH

 
 


1. Development
 

  BEFORE MARKETING

Before being put to market, our products undergo a battery of tests with several safety assessment checkpoints and ingredient tests, then a second run of tests is conducted on the formula.
Products must meet extreme criteria before being put to market. This means consumers can rest assured that the product is safe and completely harmless to their health.
  • Analysis of the toxicological profile of all the formula ingredients

We only use ingredients that have been rigorously evaluated by our scientific experts, in accordance with the European Cosmetics Regulations*
To this end, a set of criteria are evaluated for each ingredient:
  • the type of ingredient
  • the concentration of the ingredient in the product and the concentration which will come into contact with the skin
  • the contact time, which depends on the type of product (rinse-off or no-rinse)
  • the product category (face, body) and therefore the surface of exposure
  • the target, with particular attention paid to populations considered to be "sensitive", namely babies, children, pregnant women and people with pathological skin
  • packaging and the method of application

*In Europe, over 1,300 ingredients are prohibited, compared to approximately 30 in the United States
  • In vitro tolerance study (we do not conduct any tests on animals)
  • In vivo tolerance study under conditions of use and under dermatological control
 
« We have implemented an extensive evaluation protocol for our products»

Our dermo-cosmetic products must abide by the same fundamental rules applied to medical and pharmaceutical products, where no claims can be made without proof.
To guarantee the safety and innocuousness of all our formulas, we put them through strict tests, even beyond European requirements:
  • Preclinical in vitro tests
  • In vivo tests of clinical tolerance:
    • Sensitization tests under maximized conditions of exposure under medical control,
    • Cutaneous and/or ocular tolerance test under normal conditions of use, under dermatological and/or ophthalmological and/or pediatric control.
       
 


AFTER MARKETING

We put systematic checks in place for ingredients, packaging and products for each batch produced.

We implement phase IV clinical studies, of which some can be interventional and submitted to the Ethics Committee.

We conduct regular reviews based on feedback concerning cosmetovigilance and product quality. Furthermore, we have been pioneers in this approach, since it was 25 years ago that we began tolerance monitoring, on par with medical standards, for every product put to market, for the entire duration of their life cycle and on a global scale. This approach was made mandatory in July 2013 by European regulations.

 
"During the development and production stages, no fewer than 756 tests are conducted within the Pierre Fabre Dermo-cosmetics group on a Sterile Cosmetics product
made for babies with atopic skin."

 
tests-et-controles-dans-les-produits-dermo-cosmetiques

2. Clinical tests

We evaluate the tolerance of each of our products based on a Tolerance Charter specific to the Pierre Fabre Dermo-Cosmetics group, the fruit of our pharmaceutical and dermatological expertise.
 
"Every year we carry out up to 1,050 clinical studies, conducted by over 70 experts."
 
les-experts-de-ducray

Example: for a product designed for atopic skin in babies and children, the clinical program is based on 3 key steps:
  • Stage 1: Tolerance studies on healthy adults, under conditions of use for the final product, under dermatological control.
  • Stage 2: Tolerance and efficacy studies on adults with atopic skin, under conditions of use for the final product, under dermatological control
  • Stage 3: Tolerance and efficacy studies on adults with atopic skin, under conditions of use for the final product, under dermatological control

Thanks to our close collaboration with Dermatologists and Experts in the field of the Skin and Scalp, we evaluate the efficacy of our products based on clinical study protocols and efficacy standards close to those used in medicine. This is what we refer to as Pierre Fabre Clinical Expertise.

 
This video will show you how our dermo-cosmetic products are tested:  :



 

 

3. Cosmetovigilance: a unique approach for the last 25 years

«We guarantee continuous monitoring of product safety after marketing, thanks to our Cosmetovigilance department» 
  • What is cosmetovigilance?
It's a process which allows us to monitor the tolerance of our cosmetic products once they have been marketed and therefore used by patients and consumers.
For each formula, a cosmetovigilance index is calculated, corresponding to the ratio between the number of cases reported and the number of units delivered worldwide.
Depending on the index value, the formula is positioned in a Cosmetovigilance category ranging from class I (very good tolerance) to class IV (poor tolerance).

Given our status as a health company, we have decided to create our own cosmetovigilance department right within our laboratories in order to monitor consumer safety
during the use of our products after they have been marketed, in all the countries where they are sold. This international organization is also based on external and independent expertise.
This network of experts continuously monitors and re-evaluates the safety of DUCRAY products: using rigorous and recognized methods, it collects, validates and analyzes adverse events related to the use of a cosmetic
product and collects all relevant information to help improve the product.

 
  • For example, what are the results for the TOP 5 best-selling DUCRAY products* between 2016 and 2018?
The index confirms that each of the products used has very good tolerance, having obtained class I classification.