COME NASCONO I CLAIMS?

• Scope

> Skin care

• Discussion

> Behind the claims: Science

> Around the claims : Skin care regulatory environment

> Before the claims : Clinical Research Office (CRO) role

> Before the claims : Efficacy tests design

> Conclusion

RESEARCH & INNOVATION

L’OREAL

L’OREAL

MORE THAN 100 YEARS

RESEARCH

L’OREAL

THE L’OREAL GROUP RESEARCH

L’OREAL

A DRIVING FORCE BEHIND INNOVATION

A KEY FOR GROWTH

L’OREAL RESEARCH

KEY FIGURES BUDGET over 700 Millions Euros

In 2010, in term of R&D investments, L’Oréal was:

the 13th French company

the 44th EU company

the 137th worldwide company.

L’Oréal is the worldwide biggest R&D investor in the field of personal goods.

3 420 PEOPLE Over 600 PATENTS in 2013

18 RESEARCH CENTERS *

* Reason why publication often happens after a certain exclusivity period

OUR MISSIONS

TO INCREASE KNOWLEDGE OF SKIN ALL OVER THE WORLD

TO ASSESS PRODUCTS SAFETY AND EFFICACY

L’OREAL

TO MEET CONSUMERS BEAUTY ASPIRATIONS

L’OREAL

L’OREAL RESEARCH

Heterogenic Regulatory environment High variety of rules

Transverse regulation regarding advertising

Specific regulatory texts regionally and/or nationally

Professional codes of deontology / advertising guidelines

Different levels and ways of control of authorities

Specific claims definition (« Not tested on animals », suncare products in Europe…)

Positive lists / negative lists (Canada, Japan…)

Nature of needed tests: objective tests / subjective tests

Application of major principles of the International Chamber of Commerce (ICC)

(identical to the 6 criteria under article 20 of the ECR)

Major principles of ICC (1/2)

– Regulatory conformity: Communication should be conform to product status and respects current laws and regulations

– Honesty: Communication should not abuse the trust of consumers or exploit their lack of experience or knowledge

– Truthfulness: Marketing communication should not contain any statement, or audio or visual treatment which, directly or by implication, omission, ambiguity can mislead the consumer

Major principles of ICC (2/2)

– Decency: Marketing communication should not contain statements or audio or visual

treatments which offend standards of decency currently prevailing in the country and culture concerned

– Fair competition: Marketing communication containing comparisons should be so designed that the comparison is not likely to mislead, and should comply with the principles of fair competition

– Substantiation: Descriptions, claims or illustrations relating to verifiable facts in a marketing communication should be capable of substantiation.

• Technology

• Consumer Tests

• Instrumental tests

EFFICACY TESTS

• Variety of skin care products

> Creams

> Serums

Sprays

• Diversity of needs

> Men, women

> Age

> Origin, social behaviour

> Environment

EFFICACY TESTS

• Gender

> Male skin is more thicker

> Hormonal influence

> Properties of the skin are slightly different

EFFICACY TESTS

• Environment

> UV exposure

> Pollution

> Temperature conditions

EFFICACY TESTS

> UV exposure focus on environmental issue

EFFICACY TESTS

> UV exposure seasons

January July

EFFICACY TESTS

• Conclusion

> Skin is complex

> Identify and understand the biology/science/environment is key

> Adapt tests to better evaluate

EFFICACY TESTS

• Subcontractors:

> Tests are performed by subcontractors (Clinical Research organisation)

> Audit to validate a CRO

> The CRO to provide methods/protocols

> CRO is independant

EFFICACY TESTS • How it works:

> Important to drive the CRO study (man ,women?, age?, problematic, normal skin,

1 or several phototypes?)

> The tested product is blind both CRO & volunteers

> Recruitement of volunteers by the CRO using their database

> Tests are performed by the CRO in their center

> Protocol is standardized and can be selected (clinical or Instrumental or self assessment)

> Study report is provided by the CRO under its own responsibility

EFFICACY TESTS

• Instrumental tests

> Use of an Apparatus

> Can be repeated

> Reproductible

> Sensitivity

> Sturdiness/Robustness

> CRO are trained to use it

Corneometer Objective:

measures the electric impedance (capacity of the skin to conduct electricity) at the skin surface Permits to evaluate hydration of the skin

(if the impedance is low the skin is more hydrated)

Imprints

• Objective: imprints of the skin surface using the Silflo® Polymer

imprints of many zones (wrinkles …)

• It has to be combined with analysis methods to obtain the results (measurements)

EFFICACY TESTS

• Clinical tests

> Performed under the supervision of an expert

> Generally a dermatologist or medical doctor

> Expert of the skin or hair

> Evaluation of clinical signs/parameters

> Semi-objective evaluation: use of expertise

> L’Oréal has developed and published Atlas/Reference chart to

help for the evaluation

> Experts are trained with the atlas for unbiased evaluation

> Attested by an expert

WHAT IS A REFERENCE CHART ?

Precise description of the sign and its evaluation

A series of pictures, describing the different level of aging

Crow’s feet wrinkles Chart/Atlas

MODELISATION

MODELISATION

EFFICACY TESTS

• Self Assessments

> Perception by the volunteers themselves

> Evaluation by the volunteers

> Questions on the efficacy perception

> Answers made at home by using a form provided by the CRO

> Can be done on specific market (One country, One zone…)

> Can be done on specific people (age, gender, selective behaviour…)

PERCEPTION

Subject to personal judgement

CONCLUSION

INSTRUMENTAL

CONCLUSION

INSTRUMENTAL

CLINIC

CONCLUSION

INSTRUMENTAL

CLINIC CONSUMER

CONCLUSION

EFFICACY TESTS • Conclusion:

> Claims are strictly linked to the efficacy of a product

> Different possibilities to assess the efficacy

> Importance to acquire knowledge

> Importance to identify what you want to assess

> Rely on CRO to design and test

>> Congress, seminar, publication (subject to a previous exclusivity period) over the world to identify new methods/tests in order to create/substantiate new claims