CHAPTER 8

Methods for Antiperspirant and Deodorant Efficacy Evaluations

J.E. Wild,J.P. Bowman, L.P. Oddo

Introduction

Claims support documentation is a requirement for all types of products including

cosmetic products. The globalization of products has made the documentation of a
product's safety and efficacy parameters more important since these products may
have to meet several various regulatory jurisdictions. In Europe, for example, the
European Cosmetic Directive requires that products have documentation to support
the claims made [IJ . In the United States the requirement is essentially the same except
that some products that are considered cosmetic in some regulatory jurisdictions are
over-the·counter drug products in the United States.
Antiperspirant products are in this category and in the United States only certain
active ingredients previously approved by the Antiperspirant Monograph may be used
in products labeled as antiperspirants. An active ingredient not on this list must go
through the new drug approval process before it can be used in this capacity.
Our primary focus in this chapter will be to describe methods for determining the
efficacy of products that will be labeled as antiperspirants.

Product Definition

There are some misunderstandings in the minds of consumers and cosmetic scientists
about the product category known as antiperspirants. The confusion is centered
around the three terms namely antiperspirant and deodorant and what has become a
relatively new term primarily used in Europe "dry deodorant".
An antiperspirant product is designed to inhibit sweat production at the site of appli-
cation and since it inhibits the sweat which acts as a culture medium for bacteria to po·
tentially degrade and form malodor, antiperspirants can also be called deodorants. On the
other hand a product for mulated to only have deodorant activity may control malodor
through absorption, masking (i.e., fragrance) andior by antibacterial activity. Its main
function is to reduce or prevent odor, not sweat production. The term dry deodorant de-
scribes a product that delivers some level of sweat reduction and also controls malodor.
For a product to be labeled as an antiperspirant in the United States it must
demonstrate its capacity to reduce underarm sweat production to a level which is
statistically significantly greater than 20% reduction and be formulated within the
Category I guidelines of the Antiperspirant Drug Products for Over-the-Counter Hu-
man Use; Tentative Final Monograph 121. Products not formulated within these guide-
lines wi!! require submissions as new drugs.

P. Elsner et al. (eds.), Cosmetics

© Springer-Verlag Berlin Heidelberg 1999
,,' J.E. wild et al.

Antiperspirants are considered cosmetic products in oth er parts of the world and
are not subject to the efficacy requiremen ts as established by the United States Food
and Drug Administration.

Methods for Evaluating Antiperspirant Efficacy

There are three approaches for evaluating antiperspirant efficacy:

1. Visual
2. Instrumental
3. Gravimetric

Visualization Methods

There are various techniques that use starch-iodine or other suitable indicators which
produce colored spots allhe site of sweat droplets and several authors have published
this type of method for determining antiperspirant activity. Kuno [3J has provided an
overview of the early work done using colormetric techniques. These methods' and/or
adaptations are used primarily as screening tools which indicate act ivity but do not
quantify the level of antiperspirant reduction .

Instrumental Methods

Instrumental methods employ hygrometry, electrical conductance or impedance,

and thermography to evaluate the efficacy of antiperspirant products. These methods
are also considered screening tools and are not employed as typical standard anti-
perspirant efficacy evaluation techniques [4] . The most recently published method
by Buelfeldt, Frase and Gassmueller [5] describes a test wit h 16 sites on the back used
to compare eight test materials each with an adjacent control. The sweat collected on
cellulous pads was eluted and the eluates were measured for electrical conductance.
The authors reported results which were comparable to gravimetric axillary collec-
tions.

Gravimetric Methods

Gravimetric techniques were developed in order to quantify the actual amounts of

sweat produced during specific time intervals and under specific conditions. After
suitable times and conditions were established, antiperspirant applications were made
and reduction in the quantity of sweat output was then determined. Gravimetric
analysis became the method of choice for determining antiperspirant efficacy and
continues to be the most used method today [41.
Three methods have been reported as techniques for induction of sweating: (l) Am-
bient temperature and humidity [6], (2) controlled hot room environment [7], and (3)
emotional sweating [8) .