FILMAGENE™
Dermal protective cream
TECHNICAL
DOCUMENTATION
FILMAGENE™, Dermal protective cream
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FILMAGE, 20, rue Sevin-Vincent, F-92210 SAINT-CLOUD, FRANCE
FILMAGE, 20, rue Sevin-Vincent, F-92210 SAINT-CLOUD, FRANCE
FILMAGENE™, Dermal protective cream
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TABLE OF CONTENTS
1. INTRODUCTION
p 3
2. GENERAL INFORMATION
p 4
2.1. Trade name
2.2. Category
2.3. Composition
2.4. Packaging
2.5. Expiration date
2.6. Administration
3. PHYSICO-CHEMICAL DATA AND CONTROLS
3.1. Organoleptic characteristics
3.2. Storage, expiration
3.3. Barrier-effect
3.4. Microbiological analysis
4. LOCAL TOLERANCE IN THE ANIMAL
p
p
p
p
p
p
4
4
4
4
4
4
p 5
p
p
p
p
5
5
5
6
p 7
4.1. Local tolerance through the determination of the primary cutaneous
irritation index in the rabbit
p 7
4.2. Local tolerance through the evaluation of the ocular irritation in
the rabbit
p 7
4.3. Local tolerance after repeated cutaneous applications for 28
days in the rabbit
p 8
4.4. Conclusion
p 10
5. CUTANEOUS PROTECTIVE ACTIVITY IN THE ANIMAL
p 11
6. EXPERIENCE AND ACCEPTABILITY IN THE MAN
p 13
7. SUMMARY
p 14
8. REFERENCES
p 15
FILMAGE, 20, rue Sevin-Vincent, F-92210 SAINT-CLOUD, FRANCE
FILMAGENE™, Dermal protective cream
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1. INTRODUCTION
Various investigations carried out in hospital environments have shown that
frequent washings of hands, dictated by the elementary rules of hygiene, entail
cutaneous disorders, such as dryness, redness, irritation, chaps, a.s.o., in 80 % out of
the nursing staff. Other factors can aggravate this situation : e.g., hygiene products
used and inadequate drying (too short drying time, unsuitable or missing drying
material).
It seemed worthwhile therefore to develop a product endowed with treating and
protective properties, capable of relieving, or even hindering, those extremely
annoying phenomena of skin irritation, due to the peculiarity of the work in nursing
departments.
The dermal cream FILMAGENE, developed by FILMAGE Co, exerts a treating
and protective activity lasting several hours after application, even after repeated
washings.
Thanks to its peculiar galenical features, FILMAGENE exhibits a strong
covering potential, does not produce any "sticky" sensation, and does not require a
too long drying time.
FILMAGE, 20, rue Sevin-Vincent, F-92210 SAINT-CLOUD, FRANCE
FILMAGENE™, Dermal protective cream
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2. GENERAL INFORMATION
2.1. Trade name :
FILMAGENE ™.
2.2. Category :
Barrier cream.
2.3. Composition :
Oil/water emulsion complying with the following formula :
- Sorbitol,
- Sweet almond oil,
- Polysorbate 60,
- Cetylic alcohol,
- Sorbitan monostearate,
- Dimethylpolysiloxane,
- Beeswax,
- Glycerol,
- Polymer trano,
- Keratal,
- Panthenol,
- Carbomers,
- Preservatives,
- Fragrances,
- Water.
2.4. Packaging :
Cream in a 80 ml-tube for dermal use.
2.5. Expiration time :
4 years.
2.6. Administration :
Before application, the skin should be absolutely clean, dry, and not greasy.
Coat with cream fingers, nails, the palm and the back of hands, or any skin area to be
protected. Let the cream take effect 2-3 minutes. Under such conditions, skin is
protected for a period of about 4 hours, even after several washings.
FILMAGE, 20, rue Sevin-Vincent, F-92210 SAINT-CLOUD, FRANCE
FILMAGENE™, Dermal protective cream
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FILMAGE, 20, rue Sevin-Vincent, F-92210 SAINT-CLOUD, FRANCE
FILMAGENE™, Dermal protective cream
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3. PHYSICO-CHEMICAL DATA AND CONTROLS
3.1. Organoleptic characteristics :
- Bright white and smooth cream.
- No particle of size below 100 µm and numerous 50 µm-particles.
- O/W emulsion.
- pH 6.
3.2. Storage, Expiration :
In stability studies (1), FILMAGENE cream exhibited stable physical properties
for at least 4 years, except a one-unit pH decrease. Its centrifugation resistance
(stability criterion) appeared to be very good throughout the experiments. Its infrared
spectrum and rheologic properties were not modified.
3.3. Barrier effect :
The barrier effect of the protective cream FILMAGENE was studied by means
of filter papers, 30 mm in diameter, on which a small layer of cream was uniformely
spread. 100 µl of various liquids were then laid down on these filters (one liquid per
filter). The diffusion of liquids was observed and the infiltration times were
recorded.
The results were expressed according to the retention time :
Retention time
Notation
< 30 sec
0.5-1 min
1-5 min
5-10 min
> 10 min
0
+
++
+++
++++
For the control (filter paper without cream), the retention times of the different
liquids experimented were below 30 sec.
FILMAGE, 20, rue Sevin-Vincent, F-92210 SAINT-CLOUD, FRANCE
FILMAGENE™, Dermal protective cream
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The results obtained with the protective cream FILMAGENE are listed in the
following table :
Test liquid
Notation
Distilled water
1 mole/l hydrochloric acid
1 mole/l sodium hydroxide
90 % alcohol
Trichlorethylene
acetone
methanol
cyclohexane
++++
+++
+++
++
+
+
+++
+
3.4. Microbiological analysis :
FILMAGENE cream is submitted to a microbiological analysis intended for
determining the level of basal bacterial as well as fungal contamination and checking
the absence of pathogens.
FILMAGE, 20, rue Sevin-Vincent, F-92210 SAINT-CLOUD, FRANCE
FILMAGENE™, Dermal protective cream
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4. LOCAL TOLERANCE IN THE ANIMAL
4.1. Local tolerance through the determination of the primary cutaneous
irritation index in the rabbit (2) :
The test of primary cutaneous irritation is employed in order to determine the
primary irritation capacity of a test product. Is regarded as a "primary irritant agent"
any substance inducing, after a single application, a cutaneous inflammatory
reaction occurring within 24 hours and located at the zone of contact.
The primary cutaneous irritation index of FILMAGENE cream was determined
in the rabbit according to the reference method published in the Official Journal of
the French Republic of February 21, 1982.
First, the back and sides of 6 rabbits were clipped and 3 parallel incisions were
made on the right side of the vertebral axis. Twenty-four hours later, 0.5 g of the test
product was applied on each side of the animals under a semi-occlusive dressing.
FILMAGENE cream was left in contact with the skin for 24 hours.
Thirty minutes after removal of dressing and again 48 hours later (i.e., about 24
and 72 hours after application), the skin irritation was assessed at the level of the
application sites (scarified and non-scarified) by means of a numerical scale for
evaluation of erythema and edema formation. The primary cutaneous irritation index
was determined by adding the figures obtained for both erythema and edema, at 24
and 72 hours, on the 12 application areas - (1 scarified + 1 non-scarified) x 6 animals
- and then dividing the total by 24.
Under these conditions, FILMAGENE cream exhibited a primary cutaneous
irritation index of 0.5.
According to the interpretation scale recommended by the Official Journal of
the French Republic, this product has proved to be non-irritant, under the
experimental conditions adopted.
4.2. Local tolerance through the evaluation of ocular irritation in the rabbit (3) :
Like the preceding method, the test of primary ocular irritation is utilized in
order to assess the extent of the ocular irritation produced by a single instillation of a
test product into the lower conjunctival sac of one of the eyes of the rabbit.
FILMAGE, 20, rue Sevin-Vincent, F-92210 SAINT-CLOUD, FRANCE
FILMAGENE™, Dermal protective cream
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The ocular tolerance of FILMAGENE cream was studied in the rabbit according
to the reference method published in the Official Journal of the French Republic of
July 10, 1992.
0.1 g of the cream was applied into the lower conjunctival sac of the left eye of
3 rabbits.
The treated eye of the animals was examined 1 hour after administration and
again 24, 48 and 72 hours later, using the untreated eye as control. The observations
were performed in the following order : conjunctiva (chemosis, lacrimation,
conjunctival enanthema), iris, and cornea (degree and surface of opacity and/or
epithelial injury), and noted in accordance with appropriate numerical evaluation
scales. For each animal and each period of observation, the values obtained were
added so as to determine the individual ocular irritation indices (I.O.I.). The mean
value for the 3 rabbits of these I.O.I. was calculated in order to obtain the mean
ocular irritation index (O.I.) at each time of observation. The highest one was
selected as the maximum ocular irritation index (Ma O.I.).
Under these conditions, FILMAGENE cream exhibited a maximum ocular
irritation index (Ma O.I.) of 8 at 1 hour and a zero mean ocular irritation index at 72
hours.
According to the interpretation scale recommended by the Official Journal of
the French Republic, this product has proved to be practically non-irritant, under the
experimental conditions adopted.
4.3. Local tolerance after repeated cutaneous applications during 28 days in the
rabbit (4) :
The repeated application cutaneous tolerance test is especially adaptable to the
study of cosmetics and toiletries, and aimed at revealing cutaneous reactions most of
the time impossible to observe in primary irritation tests. It is based on the
observation of the local cutaneous reactions induced by repeated applications of a
given product to the skin of rabbits during 28 days.
FILMAGENE cream was submitted to the official test of cutaneous tolerance
by repeated applications in the rabbit published in the Official Journal of the French
Republic of May 25, 1993.
FILMAGE, 20, rue Sevin-Vincent, F-92210 SAINT-CLOUD, FRANCE
FILMAGENE™, Dermal protective cream
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Twelve rabbits were randomly assigned to 2 groups of 6 :
- one treated with FILMAGENE cream,
- one control.
The cream was daily applied just as it was, during 28 consecutive days, over the
right side of the rabbits, on the basis of 2 g per animal per day, the amount of
product in excess being systematically eliminated.
During the treatment period, clinical examinations were daily performed,
particularly observation of the general behaviour of animals and macroscopic
observation at the application site. The body weight and food consumption of
animals were determined weekly. The thickness of a skinfold was measured (on the
treated side and the control one) with a micrometer before the first application and at
the end of each week.
At the end of the treatment period, 2 skin biopsies were made, one on the
treated side and the other on the control one, in the rabbits treated with the cream,
for a cutaneous histopathological examination.
Clinically, no sign of local or systemic toxicity was noted, throughout the
experiment, in the FILMAGENE-treated animals. In particular, their food
consumption and body weight evolution were not modified, compared to the control.
On the other hand, after 5-6 applications of the cream, a slight and transient
cutaneous irritation was noted. At the end of the treatment period, i.e., after 28
consecutive days of application, no lasting macroscopic lesion was found.
No significant increase in skinfold thickness was recorded.
No significant effect upon the fur regrowth was observed.
Lastly, the histopathological examination of the skin biopsies showed a few
slight and aspecific irritative lesions.
In conclusion, under the experimental conditions used, the protective cream
FILMAGENE has proved to be relatively well tolerated in the rabbit, after repeated
cutaneous applications for 28 days.
FILMAGE, 20, rue Sevin-Vincent, F-92210 SAINT-CLOUD, FRANCE
FILMAGENE™, Dermal protective cream
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4.4. Conclusion :
The results obtained in the cutaneous and ocular tolerance studies performed in
the animal are clear and in good agreement. They show the good local tolerance of
the product in the animal.
FILMAGE, 20, rue Sevin-Vincent, F-92210 SAINT-CLOUD, FRANCE
FILMAGENE™, Dermal protective cream
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5. SKIN PROTECTIVE CAPACITY IN THE ANIMAL
The cutaneous protective properties of FILMAGENE cream were studied
through a trial of skin resistance to 60 % sulphuric acid in the rabbit (5).
The aim of this study was to demonstrate the capacity of FILMAGENE cream
to protect skin against the irritant and corrosive properties of a very aggressive
chemical agent.
First, the back and sides of 6 rabbits were clipped. Twenty-four hours later, 2 g
of the cream were applied to the left side of animals, the right one being used as
symmetrical control area.
Five minutes later, 2 gauze packs drenched with 60 % sulphuric acid were
deposited on the application sites of each side of the animals. They were then
removed after 1 and 2 min, respectively.
One hour after removing of gauze packs and again 24, 48, and 72 hours later,
the cutaneous irritation and corrosion were assessed at the application sites by means
of a 8-level numerical scale.
For a 2-min exposition to 60 % sulphuric acid, the mean score recorded at 1
hour amounted to 7.3 ± 0.8, without FILMAGENE, versus 6.5 ± 1.0, with the
protective treatment. The difference was statistically significant (p ≤ 0.05,
WILCOXON's test).
All the other measurements showed a non-significant reduction in irritationcorrosion scores with the protective treatment FILMAGENE, relative to a skin area
untreated.
The analysis of the score evolution between 1 hour and 72 hours revealed no
effect of the cream on the rate of dermal tissue healing.
In conclusion, under the experimental conditions adopted, FILMAGENE cream
exhibited a protective capacity against the cutaneous irritation and corrosion induced
by 60 % sulphuric acid, explainable by its "barrier-effect".
FILMAGE, 20, rue Sevin-Vincent, F-92210 SAINT-CLOUD, FRANCE
FILMAGENE™, Dermal protective cream
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Evolution of mean irritation-corrosion score for a 2-min exposition
of the skin to 60 % sulphuric acid
Mean irritation-corrosion score
8
*
6
4
2
* p Š 0.05
FILMAGENE
CONTROL
0
1 h
24 h
48 h
72 h
Observation time
Each bar represents the mean with standard deviation for 6 animals
FILMAGE, 20, rue Sevin-Vincent, F-92210 SAINT-CLOUD, FRANCE
FILMAGENE™, Dermal protective cream
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6. EXPERIENCE AND ACCEPTABILITY IN THE MAN
FILMAGENE cream was submitted to an evaluation by the staff of 5
departments (Internal Medicine and Allergology, Infectious diseases, Emergency,
Vascular Surgery, and Intensive Care) of ROTHSCHILD Hospital in PARIS, in the
treatment and prevention of hand cutaneous disorders, due to the high frequency of
washings (6).
The evaluation was based on a questionnaire intended for appreciating the state
of hands before and after the use of the protective cream for 15-30 days. A question
about the intention of using the cream at the end of the trial, if placed at the staff's
disposal by the hospital, was asked as well.
The trial was performed in 107 employees (78 % women). Nearly 82 % out of
this population exhibited hand problems, such as dryness, redness and irritation.
The analysis of the questionnaires primarily revealed that :
- FILMAGENE cream appeared not to be annoying in 80 % out of the cases,
- it evoked a feeling of acceptable or sufficient protection in 82 % out of the
cases,
- it brought about an improvement of the hand state in 63 % out of the cases
(within 10 days in 67 %),
- its drying time seemed to be reasonable in 82 % out the cases.
The results of this study showed a true "problem of hands" in the nursing staff
(about 80 % out of the subjects involved in the trial), hence a need of a product
having both treating and protective properties.
About 75 % out of the staff involved in the trial declared to be interested in
regular supplying of an adequate product.
FILMAGE, 20, rue Sevin-Vincent, F-92210 SAINT-CLOUD, FRANCE
FILMAGENE™, Dermal protective cream
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7. SUMMARY
The dermal cream FILMAGENE is an oil/water émulsion playing a barrier role
towards numerous liquids and solvents. This experimentally-demonstrated property
confers on this product a cutaneous protective activity which can be a suitable
solution to the "hand problems" encountered especially in the nursing staff, owing to
frequent washings, possibly followed by an inadequate drying, and/or an intensive
use of hygiene products.
The protective cream FILMAGENE exhibits galenical characteristics which
provide it with a strong covering capacity and do not entail any "sticky" sensation.
Its drying time has proved to be relatively short.
The experiments carried out in the animal have shown the good local tolerance
of this product and the observations performed in the man, under customary use
conditions, have revealed no intolerance phenomenon of great importance.
Thanks to the physico-chemical properties of its components and its cosmetic
qualities, the dermal protective cream FILMAGENE appears to be a suitable product
for those "hand problems" directly related to the peculiarity of the work in nursing
departments.
FILMAGE, 20, rue Sevin-Vincent, F-92210 SAINT-CLOUD, FRANCE
FILMAGENE™, Dermal protective cream
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8. REFERENCES
1.
Stability study of the protective cream FILMAGENE.
Internal report, 1996.
2.
Determination of the primary cutaneous irritation index in the rabbit. Study of a
protective cream.
Internal report, 1994.
3.
Evaluation of ocular irritation in the rabbit. Study of a protective cream.
Internal report, 1994.
4.
Appreciation of the superficial cutaneous aggressivity of a protective cream
after repeated applications during 28 days in the rabbit.
Internal report, 1994.
5.
Assessment of the protective activity of FILMAGENE cream against the
cutaneous irritation and corrosion induced by 60 % sulphuric acid in the rabbit.
Internal report, 1996.
6
FILMAGENE™, clinical documentation, 1994.
FILMAGE, 20, rue Sevin-Vincent, F-92210 SAINT-CLOUD, FRANCE