ARTICLE
"Cellulite creams", intended to reduce so-called "orange peel" skin
on the buttocks and thighs, were introduced in the 1960s. This so-called
cellulite has nothing to do with the dermatological condition known as
cellulitis, which is a deep cutaneous inflammation of bacterial origin.
In Stedman's Medical Dictionary [1] cellulite is described as follows
"Colloquial term for deposits of fat and fibrous tissue causing dimpling
of the overlying skin". External characteristics of cellulite are its
location (lower buttocks, outer and posterior thighs, hips), tissue lumpiness,
and dryness and flabbiness of the skin. Cellulite may affect up to 85%
of postadolescent women [2]. Standard dermatological textbooks either
ignore this condition [3] or discuss it brietly [4] referring to original
publications, where no special inflammatory histology was found, but some
signs of lymphoedema and increased subcutaneous fat [5]. Ultrasonic analysis
of the upper thigh and buttock tissue has demonstrated herniation of the
subcutaneous fat into the dermis [2]. The initial change leading to cellulite
formation has been suggested to be deterioration of the dermal matrix
and vasculature, particularly loss of the capillary networks, leading
to excess fluid retention within the dermal and subcutaneous tissues [2].
This loss of the capillary network is thought to be due to engorged fat
cells clumping together and inhibiting venous return [2]. Reduced lipolysis
has also been suggested to be involved in the pathogenesis of cellulitis
[6].
There is virtually no knowledge of the ingredients of cellulite creams
in the dermatological literature, even though a variety of treatments,
including xanthines, herbal derivatives, heating, massage, and skin kneading,
have been suggested to reduce the dimpled skin appearance [2]. In this
study, the well-established term "cellulite cream" is used for all slimming,
tightening and fat-reducing creams and gel products, in addition to cellulite
removers.
The objective of the present study was:
- to clarify the ingredients of cellulite creams and their safety with
special attention to allergy;
- to assess whether the products comply with regulations in terms of
not exceeding limit values stated in regulations (preservatives);
- to check the microbiological purity of the products.
Materials and methods
All cellulite creams found to be on sale in Helsinki were included,
both those sold in stores and those sold in beauty parlours. Most products
on sale in stores were acquired from Stockmann's department store in Helsinki.
Altogether 32 products were investigated (Table I). The preservatives
formaldehyde [7], as well as parabens and phenoxyethanol [8] were quantitated
according to EU regulations. Microbiological purity was studied and interpreted
according to FDA regulations [9].
The importer or manufacturer of each product was contacted for information
relating to composition, including names and percentages by weight of
all ingredients of the product. The composition data obtained was classified
according to the function of each ingredient. Functions were classified
in accordance with resolution of the Commission of the European Communities
[10]. The Commission of the European Communities classifies functions
of substances as follows: absorbents, antioxidants, antistatic agents,
biological additives, denaturants, emulsifying agents, hair dyes, film
formers, botanicals, chelating agents, cosmetic colorants, humectants,
additives, solvents, antimicrobials, opacifiers, emollients, surfactants,
buffering agents, binders, preservatives, UV absorbers, and viscosity
controlling agents. If a substance had multiple functions, it was classified
as belonging in only one group. The group chosen, e.g. emulsifying
agent or cosmetic colorant, was chosen according to the function of the
substance which seemed most likely to be serving.
Results
Laboratory investigations
The percentage of parabens ranged from 0.02 to 0.40 (Table
I). The percentage of 2-phenoxyethanol ranged from 0.05 to 0.57
(Table I). No free formaldehyde
was present in any of the products (detection limit 10 ppm). The concentrations
of parabens and phenoxyethanol were under the maximum authorized concentration,
which is for one paraben 0.4%, 0.8% for a mixture of several parabens
and 1% for 2-phenoxyethanol (The Cosmetic Directive 76/768/EEC and the
Amendments).
Microbiological investigations included searches for the following:
aerobic micro-organisms, moulds, yeast, coliform bacteria, Staphylococcus
aureus and Pseudomonas aeruginosa. None were found growing
in any product. Products were therefore considered microbiologically pure.
The ingredients of cellulite
creams
The 32 products under investigation contained 263 chemical substances
(Table II). On average,
each product contained 22 components (range 4-31 components). For the
major part of the ingredients the INCI name could be found. The products
also contained substances which could not be placed in any of the INCI
classification. Fragrance was present in all products. The concentrations
varied from 0.05 to 0.5%.
Most ingredients (n = 44) were categorised as "botanicals". The second
largest group was made up of "emollients" (39 ingredients). The plants
most frequently used were common ivy (Hedera helix), lady's mantle
(Alchemilla vulgaris) and butcher's broom (Ruscus aculeatus).
The commonest emollients were the silicon compounds cyclomethicone and
dimethicone. Most widely used humectants were propylene glycol and glycerin.
The function classification of the Commission of the European Communities
does not include active ingredients. These are categorised as "additives".
In the latter group, caffeine was present in 14 products and by far the
commonest ingredient. The maximum concentrations of caffeine and theobromine
were 2% and of theophylline 3%.
Among solvents, water was present in nearly every product. The concentrations
varied between 50 and 90%. Among preservatives, parabens (methylparaben,
ethylparaben, butylparaben and propylparaben) were most frequent. Phenoxyethanol
was also a common preservative. Preservatives based on release of formaldehyde
(e.g. diazolidinyl urea) were few. The frequent allergens methylchloroisothiazolinone/methylisothiazolinone
combination (Kathon CG) and methyldibromoglutaronitrile were present in
4 and 2 products respectively. Carbomer was a commonly used viscosity
controlling agent. The remaining substances were present in only one or
a few products.
Discussion
Published information on the content and efficacy of cellulite creams
is sparse. Some results of limited studies have been presented in cosmetic
literature [2, 6, 11-13], but not in peer-reviewed dermatological literature.
The present report is a continuation of a series of studies related to
the safety of cosmetics and consumer products [14-18]. The regulations
relating to cosmetic and consumer products often give no limit values
for allergic or irritant elements in the products [16]. Frequency of adverse
reactions to cellulite creams is not known. In various classifications,
e.g. in COLIPA (The European Cosmetic Toiletry and Parfumery Association)
frame formulations, these products are placed in an inhomogeneous category
of "various skin creams".
Like other cosmetic preparations, cellulite creams can cause adverse
effects on skin through different mechanisms. The commonest is direct
irritation, the basis of the effects of many botanicals, menthol and camphor.
Some kind of allergy has been reported for one fourth of the ingredients
present in the currently examined products [19]. Table
III presents an overview of the frequency of allergy to and sensitizing
potential of botanicals in these products according to Hausen [20], and
shows that botanicals with strong sensitizing potential are used in cellulite
creams. Arnica montana with more than 100 cases and common ivy
(Hedera helix) with more than 65 cases of contact dermatitis are
the most reported ones [21, 22]. The main allergen of common ivy, falcarinol,
is present also in Panax ginseng [21].
Allergic reactions may be anticipated particularly in consumers previously
sensitized to an ingredient of a product. The commonest groups of such
ingredients are fragrances, preservatives and plant extracts. Prevalence
of fragrance allergy in the general population has been estimated to be
at least 1% [23, 24]. Particular caution in the use of cellulite creams
should be exercised by individuals diagnosed as having exhibited contact
allergy to fragrances, balsam of Peru, or colophony. Active sensitization
by cellulite creams is less likely. However, the risk exists and increases
with vigorous rubbing or use on damaged or occluded skin. Cellulite creams
should only be applied on intact skin.
The rationale for the inclusion of botanicals in these products is in
some cases, undoubtedly, the rubefacient and irritant effect [20], but
in others it is not clear except for the smell of the essential oils and
the consumer and media interest in herbalism [23]. The assessment of allergy
risks involved in the use of botanicals is further complicated by the
fact that INCI nomenclature relates only to the scientific names of plants.
Concentration is not labelled. Whether an extract, oil, juice, wax or
other product from the plant is used and which part of the plant is employed
(root, stem, leaf, blossom, fruit, seed) are not specified. Within the
European Union, however, the manufacturers are required to keep "a dossier",
a provision of safety information for a cosmetic product including also
these aspects of their product.
Caffeine, present in 14 products was the most commonly used additive
(Table II), apparently
representing an "active ingredient". Caffeine readily penetrates the skin
[25] and caffeine-containing preparations have been reported to reduce
the thigh diameter during cellulite treatment [11]. The aim of the present
study was not to study the efficacy of cellulite creams.
Cellulite creams are recommended to be used for at least two months
morning and evening over wide areas of skin to obtain any sort of detectable
result. Therefore, a "treatment course" may prove very costly. The expensive
products on sale in beauty parlours, in particular, contained more botanicals
than the other products. The used preservatives were mostly parabens and/or
phenoxyethanol. These preservatives are considered fairly safe. Allergy
factors seem to have been taken into consideration in the development
of cellulite creams.
CONCLUSION
In conclusion, in spite of the large number of substances used in cellulite
creams their safety seems acceptable for most users. Because however one
fourth of the substances used have been shown to cause some kind of allergic
symptoms the risk of adverse effects should be taken into account when
using cellulite creams.
Article accepted on 11/9/00
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