Efficacy Testing

Alain KHAIAT, Ph.D.

SEERS Consulting

Background
Claims on products can be made based on
product efficacy;
Efficacy can be asserted from the ingredients
or from testing;

Methodological approaches
There are several methodologies that can be
used alone or in conjunction:
Sensorial approach (sight, touch, smell,
perceived efficacy) by consumers or by
experts;
Instrumental approach: these can be in vivo,
reproducing normal or exaggerated conditions
of use or ex-vivo, or in vitro for an objective
analysis of a specific activity;

Evaluation on human volunteers:

Sensorial tests
Appreciation of product performance, they give
information on observed or perceived
parameters:
Auto-evaluation:
Use test by consumers: evaluates the perception
of product efficacy based on parameters they can
feel or see. They can be blind (consumers dont
know which product they are using) or combined
with communication (concept use test);

45
40
35

91% positive

30
25
20
15
10
5
0
Excellent

Very Good

Good

Whitening Efficacy

Subjects self-assessment

Fair

Poor

Evaluation on human volunteers:

Sensorial tests
Evaluation by trained expert panels: must be
done by trained experts, following a well
defined protocol with precise sensorial
criteria. Examples include deodorant efficacy,
product feel, etc.

Evaluation on human volunteers:

Evaluation by professional experts
Tests under medical supervision: parameters
evaluated by medical observation and/or
scoring. They can be quantified;

ACNE CLASSIFICATION AND GRADING

Mild
Papules/pustules +/++
Nodules 0

Moderate
Papules/pustules ++/+++
Nodules +/++

Severe
Papules/pustules +++/++++
Nodules +++

Evaluation on human volunteers:

Evaluation by professional experts
Other professionals: hairdressers or other
professional experts will evaluate the tactile or
visual appreciation i.e. combability with wet
(or dry) hair, hair silkiness, etc.

Instrumental tests
Precisely measure given parameters according
to a defined protocol following the application
of a product by human volunteers:
Laboratory instrumental tests: controlled
conditions/environment; hydration,
roughness, SPF, elasticity, melanin, etc.
Instrument + experts: colorimetric,
trichogram, hydration, etc.

Ex-vivo / in-vitro tests

Ex-vivo: tests performed on a biological
substrate taken from a living organism: hair
strands, skin explants, skin tape strips, etc.
In-vitro: tests performed on molecules or cells
in culture: tyrosinase inhibition, melanocyteskeratinocytes co-cultures, etc. But also test on
glass plates to measure UVA protection
(correlation);

Study Design
The first thing is to define clearly the objectives of
the test:

Purpose of the investigation;

What information is required;
How is the data going to be analyzed?
Minimize possible bias: randomization, pairing, etc.

Ex: The primary objective of this study will be to evaluate the lightening
effect of products #960", "#514 after 28, 42 and 84 days of twicedaily use. This will be an open and parallel groups study;

Study Design
Different designs can be used:
Randomized;
Blind (single, double) or open;
Single product or vs. control;
Same subject using 2 products or different panels;

Product tested
Type of product;
Quantity to be applied and frequency of
application (e.g. use on the face, once a day);
Product to be tested and reference (if
applicable): i.e. use product 430 on one cheek
and product 750 on the other one;
Form:
Emulsions
Packaging:
Tubes of 200g
Application zone: Face normal application, twice a day (morning and
evening on cleaned face)

Volunteers
Before doing any test on humans, product
safety must be established;
Volunteers must sign an informed consent;
Inclusion and exclusion criteria;
Number of subjects: based on expertise or
statistics;

Volunteers
General criteria

Healthy subject;

Subject having given his/her informed, written consent;

Cooperative subject, aware of the necessity and duration of controls so that

perfect adhesion to the protocol established by the clinical trial center could have
been expected;

Specific criteria

Sex: Female;

Age: between 18 and 50 years;

Phototype III and IV;

Exclusion

Pregnant or nursing;

Excessive exposure to sunlight;

Subject enrolled in another clinical trial during the period;

Sample size and Power

Select sampling and measurement systems:
What instrument is going to show the effect
expected?
Should expert grading be used?

The smaller the magnitude of the effect, the

larger the sample size;
Power of a study represents the magnitude
detectable: 90% - 95%;

Statistical tests
Data properties: normal, etc.?
Type: qualitative, quantitative?
Select appropriate statistical tests;

Design experiment:
Replication?
Randomization?

Test
Conduct the test following the protocol and
collect data;
Assess data:
Check against assumptions;
Variability;
Any discordant values?
Establish visual plots;

Calculate statistical results;

Statistical interpretation
Interpretation includes:
Statistical significance;
Practical significance;

The purpose of applying statistical methods is to

get an objective assessment of the
information derived from the data

Review

Accept conclusions;
Objective achieved?
Objective modification needed?
More data required?
Are the results showing a significance i.e.
p<0.05?

Clinical Study
Understanding Acne Dynamics
Study Location:

Asia-Pacific Skin Testing Center

Manila, Philippines
Study Population: Females, age 13-29, Fitzpatrick skin phototype IV to V,
mild to moderate facial acne with at least 1 acne lesion no more
than 24 hours and has not been treated
Test Product::
None
Base Size:
16
Study Method:
Open study design.
Untreated acne lesion was monitored for 2 weeks.
Evaluations:
Lesion erythema (redness) via reflectance spectrophotometry
Elevation (swelling) and size via UVA light video camera
Inflammation via fluorescence spectrophotometry
2D and 3D images to capture changes on lesion
Baseline, Days 1, 2, 4, 7 and 14
7th Asian Societies of Cosmetic Scientists Scientific Conference
March 8, 2005, Bangkok, Thailand

Oxy-Hemoglobin Absorbance

Untreated Target Lesion Erythema via Spectrophotometry

1.00
0.80
0.60
0.40
0.20
0.00
0

10

11

12

13

Day

Acne lesion erythema is very high at the beginning; plateaus between Days 2 to 4, then begins to
decrease in succeeding days.
Closed symbols mean significant difference vs. baseline (p<0.05).

14

Untreated Target Lesion Elevation and Size

3.00

2.50

mm

2.00

1.50

1.00

0.50

0.00
0

10

11

12

13

14

Day

Height

Width

Acne lesion width peaks at Days 1 to 2, decreases to Day 7, then plateaus. Width remains to be a
concern even after acne resolution (scarring).
Significant decrease in acne lesion height begins at Day 4.
Closed symbols mean significant difference vs. baseline (p<0.05).

Untreated Target Lesion Inflammation via Spectrophotometry

Value (at 280 nm wavelength)

0.450
0.400
0.350
0.300
0.250
0.200
0.150
0.100
0.050
0

10

11

Day

Acne lesion inflammation peaks at Day 2, plateaus and starts to resolve at Day 7.
Closed symbols mean significant difference vs. baseline (p<0.05).

12

13

14

INSTRUMENTS

SPF test ISO 24444:2010

SPF is the ratio of MED(u) to MED(p) i.e. the
minimal erythemal dose of each subject
unprotected skin to protected skin;
The SPF of a product is the mean arithmetic
value of the different SPF(i);
Subjects: minimum 10 and maximum 20; must
be type I,II or III (i.e. very light skin
Caucasians);
In vitro SPF measurements have not been validated

Equipment for SPF testing

28

UV A protection
In vitro test is being finalized by ISO and
should be approved and published before end
of 2010;

MOISTURIZATION
1. TEWAMETER

Measurement of Trans-Epidermal Water Loss (TEWL);

Skin moisturization & Moisture retention;

2. SKICON or CORNEOMETER
Skicon: Measurement of skin conductance high conductance
= high moisture level;
Corneometer: Skin dielectric constant (resistivity) high
dielectric constant (low resistivity) = high moisture level;

Tewameter

Corneometer

Oil
Sebumeter or Subufix: tape transparency

Special Foils Sebufix F 16 and Corneofix F 20

Tapes to show the sebum production (qualitatively)
especially well visible
with the Visioscope
cameras. The oil
production can be
monitored live in real
time.
and the desquamation (scaliness/dryness)
of the skin with the adhesive tape

Mechanical properties
Cutometer: Elasticity, fatigability, elongation,
etc;

Skin color
Chromameter: The Chromameter converts
colors perceived by man to a digital code
composed of three parameters:
L*: for clarity (from dark to light),
a*: for the green-to-red spectrum,
b*: for the blue-to-yellow spectrum,

Skin Color
Mexameter or DRS (diffusion reflectance
spectroscopy): measure redness
(oxyhemoglobin) and pigmentation (melanin)

Digital Imaging
High resolution digital
imaging allow for
comparisons of pictures
before and after,
quantification of pixels
can be done. Variety of
lighting: white,
polarized, UV, etc.

Digital Imaging

Visioface

UV photography Subject # 3

D0

D 28

Wrinkles
Silicone imprints with measurement of the
furrows;
Direct measurement on the skin with Primos;

D0

Improvement of the medium depth wrinkles

with the use twice a day of a cream

D28

Slimming
Echography
Tape measuring
Picture of the
silhouette

ECHOGRAPH
(ADIPOSE TISSUE
THICKNESS)

Oral tests

Chromameter : Whitening;
Intra-oral photography;
Staining tablets : Plaque;
Subject assessment of relief : Sensitive teeth;

44

Hair tests
Parallel polarized photography : image
analysis to assess shine on hair;
Chromameter : Hair color;
Microscopy : Hair damage;
Instron stretching : Hair strength and
elasticity;

Scanning electron microscopy of hair shaft emerging from a follicle

at epidermal surface

Elasticity
One of the most important properties;
Can resist forces that could change its shape,
volume and length;

Allows spring back to its original form without

damage;
Wet hair can increase the length up to 30%
and return to original length when it is dried;

Elasticity (con.)
Elasticity of hair depends on the long keratin fibers in
the cortex;

Chemical treatment can alter the cortex and change

the hair elasticity;

Elasticity (con.)
Poor elasticity:
- stretch only to a limited extent;
- will break easily;
- cannot be permed satisfactorily;
Natural sunlight and artificial UV light damage hair
and alter its elasticity;

Tensile and Elasticity of hair

Instron equipment to measure the strength of hair

Conclusions

Conclusions
The conclusions drawn from the test refer to:
Improvement vs. baseline;
Improvement vs. control;

Panelists self-assessment: very important it

reflects perceived efficacy as in real life. It also
gives indications on safety and product
esthetics;

Conclusions
If the results show p<0.05, the data is
significant and the hypothesis are confirmed,
the number of panelists was appropriate and
the conclusions can be drawn;
If the results show p>0.05, the data is not
significant; either the number of panelists is
too low or the hypothesis is not correct or the
protocol needs to be reassessed;

Define objective

Select sampling and

measurement
systems

Design experiment

Data collection & Data

management

Assess data
properties

Select appropriate
statistical tests

Data collection & Data

management

Assess data

Calculate statistical
results

Report conclusions

Interpret statistical
results

Review

Exercises

Exercise 1
In the hands-out you have the results of a
moisturization test;

Question: what is your conclusion?

Exercise 2
In your hands-out you have the results of a
whitening test

Question: whats your conclusion?

Exercise 3
You have to develop the claim support for an
anti-wrinkle product or ingredient:

Design the protocol!

THANK YOU