Therapeutic agent for the external treatment of psoriasis, tinea and eczemas

The subject of the invention is a pharmaceutical composition for the external treatment of psoriasis, tinea and eczemas, comprising coconut oil, palm kernel oil, an extract of Laurus nobilis (Linn.) and an emulsifier.

BACKGROUND OF THE INVENTION 
1. Field of the Invention 
The object of the present invention is to provide a pharmaceutical 
composition for the external treatment of psoriasis, tinea and eczemas, 
with which treatment on humans has proved very successful. Even "hopeless 
cases" have shown distinct healing. A further object of the invention is 
that the composition for topical application makes possible a therapy 
which is free from side effects. 
2. Prior Art 
Therapeutic agents which are known for the external treatment of psoriasis, 
tinea and eczemas have not yet proved sufficiently effective, so that 
topical ointments based on tars have frequently been used in combination 
with an X-ray treatment. 
SUMMARY 
The subject of the invention is a pharmaceutical composition for topical 
application for the external treatment of psoriasis, tinea and eczemas, 
which comprises 30 to 50 percent by weight of coconut oil, 30 to 50 
percent by weight of palm kernel oil, 5 to 15 percent by weight of laurel 
oil from Laurus nobilis (Linn.), and 5 to 15 percent by weight of an 
emulsifier, the percentages by weight summing up to 100 percent by weight. 
In one embodiment of the composition of the invention, it may contain wool 
fat as emulsifier. 
In another embodiment, the composition may contain wool wax alcohols as the 
emulsifier. 
In a further embodiment, the composition may contain salts of 
pharmacologically permissible metals of aliphatic monocarboxylic acids 
with 10 to 22 carbon atoms as the emulsifier. 
In an additional embodiment, the composition may contain mono- and/or 
di-glycerides of aliphatic monocarboxylic acids with 10 to 22 carbon atoms 
as the emulsifier. 
In still an additional embodiment, the composition may contain about 50 
percent by weight of coconut oil, 30 percent by weight of palm kernel oil, 
10 percent by weight of laurel oil, and 10 percent by weight of wool fat. 
In a further embodiment, the composition contains about 40 percent by 
weight of coconut oil, 40 percent by weight of palm kernel oil, 10 percent 
by weight of laurel oil, and 10 percent by weight of zinc stearate. 
In a still further embodiment, the composition contains about 50 percent by 
weight of coconut oil, 30 percent by weight of palm kernel oil, 10 percent 
by weight of laurel oil, and 10 percent by weight of zinc stearate. 
In still an additional embodiment, the composition contains about 30 
percent by weight of coconut oil, 50 percent by weight of palm kernel oil, 
10 percent by weight of laurel oil, and 10 percent by weight of zinc 
stearate. 
In another embodiment, the pharmaceutical composition contains small 
amounts of antioxidants. 
In yet another embodiment, the pharmaceutical composition contains small 
amounts of preservatives. 
Coconut oil is isolated from the fruit of the coconut palm (Cocos nucifera) 
and contains, as the main constituents, 50 to 60% of caprilolauromyristin 
and 15 to 20% of myristodilaurine. In addition it contains small amounts 
of oleic acid glycerides, palmitodimyristine and stearodipalmitine. With 
reference to the fatty acid composition (in percentage) of coconut oil, 
Ullmanns Encyklopadie der technischen Chemie (Ullmans Encyclopedia of 
Technical Chemistry), 4th Edition, Volume 11 gives, on pages 458 and 459, 
13 percent of C.sub.10 and lower saturated fatty acids, 45 to 50 percent 
of C.sub.12 saturated fatty acids, 8 to 9 percent of C.sub.16 saturated 
fatty acids, and 2 to 3 percent of C.sub.18 saturated fatty acids, traces 
of C.sub.14/1 unsaturated fatty acids, traces of C.sub.16/1 unsaturated 
fatty acids, 5 to 8 percent of C.sub.18/1 unsaturated fatty acids, and 1 
to 3 percent of C.sub.18/2 unsaturated fatty acids. The content of free 
fatty acids in coconut oil is 5 to 17 percent (calculated relative to 
oleic acid). Coconut oil, as used in this specification, is also 
designated coconut fat or coconut butter, both in the literature and in 
commerce. It is preferred that the coconut oil employed be natural, but 
synthetic coconut oil prepared in accordance with foodstuff technology can 
also be used for the present invention. 
According to the citation, in Ullmanns on pages 458 and 459, palm kernel 
oil contains, with reference to the fatty acid composition (in 
percentage), 7 percent of C.sub.10 and lower saturated fatty acids, 47 to 
52 percent of C.sub.12 saturated fatty acids, 16 percent of C.sub.14 
saturated fatty acids, 6 to 9 percent of C.sub.16 saturated fatty acids, 2 
to 3 percent of C.sub.18 saturated fatty acids, 10 to 18 percent of 
C.sub.18/1 unsaturated fatty acids, and 1 to 3 percent of C.sub.18/2 
unsaturated fatty acids. Palm kernel oil contains 0.4 to 9.8 percent of 
free acids. 
In its properties and characteristic values, palm kernel oil is very 
similar to coconut oil; however, compared with the latter, it contains 
more oleic acid and only half as much C.sub.8 and C.sub.10 fatty acids in 
its glycerides. The palm kernel oil glycerides consist of 60 to 65 percent 
of tri-saturated components, about 25 percent of 
disaturated-monounsaturated components, and 10 to 15 percent of 
monosaturated-diunsaturated components. Palm kernel oil, as used in this 
specification, is also designated palm kernel fat in the literature and in 
commerce. It is preferred to use natural palm kernel oil, but synthetic 
palm kernel oil prepared in accordance with foodstuff technology can also 
be used for the present invention. 
"Laurel oil", as used in this specification, is understood to be the 
product "Oleum Lauri" described on pages 470 to 471 of the Deutsches 
Arzneibuch 6 (German Pharmacopoeia, 6th Edition), that is to say, the 
yellow-to-green semi-solid mixture of fats and oils, and lipid 
compositions expressed from the fruits of Laurus nobilis (Linn.) using 
heat or isolated by boiling. Laurel oil melts at approximately 36.degree. 
C. to give a dark green liquid which has a spicy odor and a bitter taste 
and mainly consists of lauryl laurate, lauryl stearate, and the essential 
oils and lipid components. 
The laurel oil described above is also occasionally known as "laurel 
tallow" in the literature and in European commerce. It is a greenish fatty 
composition which is isolated from the fresh fruits of the laurel (Laurus 
nobilis (Linn.)). The density is approximately 0.88, the melting point is 
about 40.degree. C., the saponification number is 198-199, and the iodine 
number is 68-80. Each of "laurel oil" and "laurel tallow", as defined in 
Deutsches Arzneibuch 6, and as defined above, may be used in the practice 
of this invention. 
Yet a further embodiment of the novel compositions of the invention 
comprises a composition in which the laurel essential extract consists of 
a mixture of 50 to 100 percent by weight of "laurel tallow" and 50 to 0 
percent by weight of "laurel oil", as the terms are used in literature and 
commerce. 
As used in this specification, laurel oil is defined as a mixture of fats, 
oils, and lipid components which is isolated from the leaves and berries 
of laurel, i.e., the plant Laurus nobilis (Linn.), and is a pale yellow 
oil which has a spicy odor and contains about 50 percent of cineol, as 
well as .alpha.-pinene, linalool, citral, geraniol, eugenol, and hitherto 
unidentified substances. In the Merck Index, 9th Edition (1976), page 707, 
No. 5228, there is defined: "Laurel Oil. Laurel berry oil. Fixed oil from 
fresh fruit of Laurus nobilis L., Lauraceae. Constit. Chiefly the lauryl 
alcohol esters of lauric, stearic, etc. acids and a volatile oil, the 
so-called laurel camphor. Greenish, fatty solid; the green color due to 
presence of some chlorophyll. d about 0.88. mp about 40.degree.. 
n.sub.D.sup.25 1.4783. Sapon no. 198-199. Iodine no. 68-80. Insol in 
water; sparingly sol in alcohol; sol in benzene, ether, carbon disulfide." 
The term "laurel camphor" for the volatile oil defined in the Merck Index 
definition of "Laurel Oil" is not identical with Camphor USP, which is a 
solid ketone of the formula C.sub.10 H.sub.16 O which is isolated from the 
plant Cinnamomum camphora (Linn.), or the synthetic isomorph thereof 
defined in Remington's Pharmaceutical Sciences, 13th Edition, page 813 
(1965). The volatile oil defined as laurel camphor in the Merck Index and 
the solid substance (Camphor USP) are very different things and are not to 
be confused. In the practice of the invention of this specification, no 
Camphor USP is contained in "laurel oil" or "laurel tallow". Camphor USP 
is neither found in nor contemplated as a component of the instant novel 
compositions. 
It is readily apparent that the "laurel oil" of the Merck Index definition 
is identical with the "laurel tallow" of European literature and commerce, 
and that the "laurel oil" of European literature and commerce is the 
"laurel oil" of the Merck Index definition enriched or more concentrated 
in the more volatile, lower-melting fats, essential oils, and lipid 
components. As used in this specification, "laurel oil" differs from 
"laurel tallow" in a composition sense solely in that the former contains 
somewhat more of the volatile components than does the latter, which 
latter is somewhat richer in the higher-melting lauryl alcohol esters of 
lauric and longer-chain fatty acids. Both "laurel oil" and "laurel tallow" 
derive from the same biological source, i.e., the fruits and leaves of 
Laurus nobilis (Linn.). 
In the sense of this invention, emulsifiers are defined as those which are 
pharmacologically and physiologically tolerated by the diseased skin 
surface to be treated and which impart a favorable consistency to the 
compositions hereof for their topical application to the skin, and which 
facilitate the taking up of the therapeutic agent by absorption and/or 
resorption and/or persorption. 
Suitable emulsifiers and emulsifying mixtures which meet these requirements 
are known to those skilled in the art and are set forth, for example, in 
the book Rompp, Chemie Lexikon (Chemical Dictionary), 6th Edition, 1966, 
Volume I, columns 1799 to 1806, along with further literature references 
and a list of suppliers. 
Examples of emulsifiers which can be used are: wool fat, wool wax alcohols, 
salts of pharmacologically permissible metals with aliphatic 
monocarboxylic acids with 10 to 22 carbon atoms, such as calcium stearate, 
magnesium stearate, aluminium stearate or zinc stearate, and emulsifier 
mixtures of mono- and/or diglycerides of aliphatic monocarboxylic acids 
with 10 to 22 carbon atoms. 
The compositions of the invention can also contain small amounts of 
antioxidants to prevent oxidative destruction of those components of the 
composition susceptible thereto. Antioxidants and their use are described 
in the chapter "Antioxidantien" ("Antioxidants") in Volume 8 of Ullmanns 
Encyklopadie der technischen Chemie (Ullmanns Encyclopedia of Technical 
Chemistry), 4th Edition. The compounds in the table below have been found 
effective as antioxidants in the practice of this invention, and are 
listed therein together with their customary range of incorporation, in 
percentage by weight, relative to the total weight of the composition. In 
addition, compounds which function as synergists to the antioxidants are 
also set forth in the table. 
______________________________________ 
Antioxidants % by weight 
______________________________________ 
L-Ascorbic acid 0.03-0.20 
2-/3-tert.-butyl-4-hydroxy-anisole (BHA) 
0.005-0.02 
2,6-di-tert.-butyl-4-hydroxy-toluene (BHT) 
0.005-0.12 
alkyl gallates 
alkyl = C.sub.3 H.sub.7 (PG), C.sub.8 H.sub.17 (OG) or C.sub.12 H.sub.25 
(DG) 0.008-0.10 
nordihydroguaiaretic acid (NDGA) 
0.005-0.025 
3,3'-thio-dipropionic acid 
0.01-0.02 
3,3'-thio-bis-(propionic acid alkyl esters) 
alkyl = C.sub.12 H.sub.23 (DLTDP) or C.sub.18 H.sub.37 (DSTDP) 
0.01-0.09 
Tocopherols 0.01-0.30 
and more 
2,4,5-trihydroxy-butyrophenone (THBP) 
0.01-0.02 
ascorbic acid esters, for example, ascorbic 
acid myristate, ascorbic acid palmitate or 
ascorbic acid stearate 0.01- 0.015 
Synergists: 
L-Ascorbic acid, lecithin, phosphoric acid, 
polyphosphoric 
acid, tartaric acid and citric acid 
______________________________________ 
The pharmaceutical compositions of this invention can also contain small 
amounts of preservatives to prevent microbiological degradation. 
Preservation by chemical agents is described on pages 440 to 461 in Volume 
11, 1960, of Ullmanns Encyklopadie der technischen Chemie (Ullmanns 
Encyclopedia of Technical Chemistry), 3rd Edition. Examples of 
preservatives effective in the practice of this invention are methyl 
p-hydroxy benzoate, ethyl p-hydroxy benzoate, propyl p-hydroxy benzoate, 
and sorbic acid. In general, the addition of about 0.01 to 0.2 percent by 
weight of preservative, relative to the weight of the total composition, 
suffices to prevent growth of molds, yeasts and bacteria and consequent 
spoilage and loss of efficacy of the compositions. A particularly useful 
preservative consists of seven parts of methyl p-hydroxy benzoate and 
three parts of propyl p-hydroxy benzoate, which mixture is effective at a 
total amount of 0.1 percent by weight, relative to the weight of the total 
composition. 
The topical pharmaceutical compositions of this invention can be 
manufactured using customary methods of the pharmaceutical compounding 
art. Thus, the components can be brought into the mobile or fluid state by 
careful warming to about 35.degree. to 50.degree. C. and combined by 
stirring, the emulsifier or emulsifier mixture then being added and finely 
dispersed. 
If desired, a completely homogeneous spreadable product can be manufactured 
by processing the batch produced in this way in a homogenizer, in which 
the batch is forced through nozzles under high pressure. 
If the product has become highly viscous due to storage at low 
temperatures, or if it should be found to contain crystalline fractions, 
it can be restored to a state in which it is very readily spreadable by 
gentle warming to about 30.degree. C. 
Psoriasis is a disease for which there has been no satisfactory method of 
treatment to date. The cause of psoriasis is unclear, but genetic factors 
appear to play a major role. 
The therapeutic composition of the invention is a combination of active 
compounds which is novel for the treatment of psoriasis and represents a 
therapy free from side effects. Excellent therapeutic results have been 
achieved in preliminary medical tests, even in "hopeless cases". 
By penetrating into the diseased tissue, the active components of the 
compositions herein apparently produce necrosis of the infected cells, 
which is apparent in the form of dermal shedding around the areas of 
erythematous development. The efficacy of the compositions is also 
demonstrated by the fact that no punctiform hemorrhages occur. After 
topical application to the effected sites, a gratifying alleviation of the 
irritating itching is noticeable after a few days. 
In the initial stages of treatment, visible reddening of the skin areas 
which are regenerating usually arises as a result of increased blood flow. 
The treatment period varies from individual to individual. Diseases in the 
primary stages require a considerably shorter period to demonstrate 
beneficial results (six to eight weeks). Despite reddening of the skin, 
the treatment can be continued until a normal skin color and gross 
appearance have returned to the affected site. 
The fields of efficacy for the novel compositions comprise the topical 
treatment of psoriasis, tineas, and eczemas; the treatment is indicated in 
particular in the case of chronic diseases. 
Unless otherwise prescribed by the doctor, the composition of the invention 
may conveniently and effectively be applied, or lightly rubbed into the 
affected areas of the skin three times a day. The treatment can be 
continued for a prolonged period without hesitation, or the development of 
distressing side effects. 
After the composition has been topically applied, all contact with water 
should preferably be avoided for a period of at least thirty minutes. 
It is appropriate to carry out the treatment with the compositions of the 
invention under medical supervision. 
No side effects, concomitant symptoms, contra-indications, or risks have 
become known to date. 
The following tests have been carried out to prove the therapeutic 
effectiveness of the compositions of the invention. 
TEST 1 
Skin compatibility of coconut oil, palm kernel oil, and emulsifier on the 
healthy skin 
In the first instance, compatibility tests were carried out on the healthy 
skin of forty voluntary persons, consisting of twenty men and twenty women 
of 21 to 70 years of age. By these investigations it was confirmed that 
coconut oil, palm kernel oil, and the emulsifiers mentioned in this 
application, as sole substance or in combination one with the other, are 
tolerated without irritation on the healthy skin. 
These personal investigations and results are in agreement with the results 
of examinations of the manufacturers. 
TEST 2 
Skin compatibility test of laurel oil, melting point 36.degree. C., and 
laurel oil (laurel tallow), melting point 40.degree. C., on the healthy 
skin 
The same forty persons were used for this test. Laurel oil (or laurel 
tallow) was applied and rubbed in in the liquid state in small amounts of 
50.+-.5 mg. After thirty minutes, the treated skin was observed. In 
sixteen men and seventeen women slight reddening of skin with the feeling 
of slight manifestation of irritation was observed. 
After thirty minutes, 50.+-.5 mg laurel oil was again applied to the skin 
of fifteen men and sixty minutes later, a very distinct itching irritation 
with reddening had occurred with nine men, and for six men formation of 
pustules, reddening and itching irritation had set in. 
After 24 hours, one man complained of allergic malady. 
These investigations have shown that laurel oil (or laurel tallow) applied 
alone on the healthy skin produces appearance of irritation. 
TEST 3 
Skin compatibility tests of therapeutic agents according to this 
application on the healthy skin 
30 to 50 percent by weight of coconut oil, 
30 to 50 percent by weight of palm kernel oil, 
5 to 15 percent by weight of laurel oil, 
5 to 15 percent by weight of emulsifier. 
The agents used in these tests were manufactured according to Examples 1 to 
77 following. The same forty persons were used as in the previous tests. 
Surprisingly, good compatibility of the compositions appeared with the 
healthy skin. 
TEST 4 
Skin compatibility tests of laurel oil, melting point 36.degree. C., and 
laurel oil (laurel tallow), melting point 40.degree. C., on the ill skin 
(psoriasis, tinea and eczemas) 
These examinations were carried out as described under Test 2, but there 
was proved the reaction on the ill skin of 
(a) six men--illness: psoriasis 
(b) two men and two women--illness: tinea 
(c) four men and one woman--illness: eczema. 
Four men of group (a), two men and one woman of group (b), and three men 
and one woman of group (c) had noted a strong burning pain upon 
application. The four men of group (a) tried spontaneously to wipe the 
test substance off their skin. Inflammation focus, perceived as point of 
pain and burning, appeared at two men of group (a), one woman of group 
(b), and one man of group (c) in the course of fifteen minutes. 
These tests show that laurel oil and laurel tallow, with melting points of 
36.degree. C. and 40.degree. C. respectively, are not compatible on the 
skin diseased with psoriasis, tinea and eczemas; moreover, skin irritation 
is produced. That is the reason that these substances cannot be used as 
therapeutic agents alone. 
TEST 5 
Skin compatibility tests of therapeutic agents according to the present 
invention on the skin diseased with psoriasis, tinea and eczemas 
For these tests there were used agents, manufactured according to Examples 
1 to 77. These examinations were carried out as described under Test 2, 
evaluating the reaction on the ill skin of: 
(a) six men and four women--illness: psoriasis 
(b) four men and four women--illness: tinea 
(c) four men and two women--illness: eczema. 
In a completely concordant manner, no skin irritation or risk factor was 
determined. 
TEST 6 
Therapeutic examination on the skin, diseased with psoriasis, tinea and 
eczemas 
The skin, diseased with psoriasis, tinea and eczemas of the test persons 
who placed themselves at the disposal, for the skin compatibility tests of 
therapeutic agents according to the present invention, was proved with the 
following combinations: 
I. 
45 percent by weight of coconut oil 
45 percent by weight of palm kernel oil 
10 percent by weight of emulsifier 
II. 
80 percent by weight of coconut oil 
10 percent by weight of laurel oil 
10 percent by weight of emulsifier 
III. 
80 percent by weight of palm kernel oil 
10 percent by weight of laurel oil 
10 percent by weight of emulsifier 
IV. 
30 to 50 percent by weight of coconut oil 
30 to 50 percent by weight of palm kernel oil 
5 to 15 percent by weight of laurel oil 
5 to 15 percent by weight of emulsifier. 
The combination I, II, III, and IV were applied on and lightly rubbed into 
the skin at different sites of the same person, three times daily. 
Combination I did not show any effect after six weeks. 
The combinations II and III, in comparison with combination I and with the 
untreated skin, showed a small therapeutic, but not sufficient, effect 
after six weeks. 
Upon examination of combination IV according to the invention, after six 
weeks, in all cases good therapeutic results were confirmed. 
As experience and the test results have shown, the therapeutic effects are 
obtainable only with a composition made according to the present 
invention. 
Further, the following additional tests were carried out to prove 
effectiveness of the therapeutic combination of the present invention. 
TEST GROUPS 
(A) 
Forty people, twenty male, twenty female, in the age group 21 to seventy, 
free from skin diseases. 
(B)(a) 
42 people, 22 male, twenty female, suffering from chronic psoriasis, age 
group 18 to 45. 
(b) 
Eight people, four male, four female, suffering from tinea, age group 30 to 
42. 
(c) 
Twelve people, four male, eight female, suffering from eczema, age group 27 
to 36. 
(C)(a) 
114 people, fifty male, 64 female, suffering from chronic psoriasis, age 
group 18 to 63. 
(b) 
Twenty people, ten male, ten female, suffering from tinea, age group 25 to 
42. 
(c) 
Twenty people, eleven male, nine female, suffering from eczema, age group 
26 to 36. 
Group C partially contains Group B. 
All test people volunteered for the tests. 
TESTED PHARMACEUTICAL COMPOSITIONS ACCORDING TO THE INVENTION 
(A) Forty percent coconut oil; forty percent palm kernel oil; ten percent 
laurel oil; 9.9 percent Ca-stearate; 0.1 percent hydroxybenzoic acid 
ester. 
(B) Fifty percent coconut oil; fifty percent palm kernel oil; ten percent 
laurel oil; 0.08 percent tocopherol; 9.92 percent lanolin. 
(C) Thirty percent coconut oil; fifty percent palm kernel oil; 8.4 percent 
laurel tallow; 3.6 percent etheral laurel oil; ten percent zinc stearate. 
(D) 45 percent coconut oil; 45 percent palm kernel oil; five percent laurel 
oil; 0.05 percent sorbic acid; 0.015 percent ascorbic acid-palmitate; 
4.935 percent wool wax alcohols. 
TESTS CARRIED OUT ON HEALTHY PATIENTS 
(1) Skin compatibility tests of coconut oil, palm kernel oil and 
emulsifying agents on healthy skin: 
With Test Group A, first of all compatibility tests were carried out on the 
healthy skin. By means of these tests it was confirmed that coconut oil, 
palm kernel oil and those emulsifiers named in this patent application, 
either as sole substance tested or in combination applied to the healthy 
skin, were tolerated without irritation. 
Said tests and results correspond entirely with the results of the tests 
carried out by the various manufacturers. 
(2) Skin compatibility tests of laurel oil, melting point 36.degree. C. and 
laurel oil (laurel tallow), melting point 40.degree. C., on the healthy 
skin. 
The same forty people were used for this test. 
Laurel oil or laurel tallow was applied in a liquid state in a small 
quantity of 50.+-.5 mg and rubbed in. 
After thirty minutes the treated skin was observed. In the case of sixteen 
men and seventeen women, slight skin reddening was observed along with the 
sensation of slight irritation. 
In the case of fifteen men, a renewed quantity of 50.+-.5 mg laurel oil was 
applied after thirty minutes. After sixty minutes, nine men experienced a 
very marked irritation together with reddening and six men experienced the 
formation of blisters, reddening and irritation. After 24 hours one man 
complained of allergic conditions. 
These tests have shown that laurel oil or laurel tallow when applied alone 
to the healthy skin cause irritation. 
(3) Skin compatibility tests of therapeutic agents, according to the 
invention, on the healthy skin: 
Test Group A; compositions A+C. 
Surprisingly enough, there was a good compatibility of the preparations on 
the healthy skin in the case of 39 test people. In one case (female), 
composition C produced a slight reddening, which was subjective but not 
regarded as unpleasant. 
(4) Skin compatibility tests of laurel oil, melting point 36.degree. C., 
and laurel oil (laurel tallow), melting point 40.degree. C., on the 
diseased skin (psoriasis, tinea and eczemas). 
These tests were carried out as described in Test 2. 
Test Groups B(a), B(b), B(c). 
Twelve men and twelve women from the Group B(a), four men and two women 
from the Group B(b) and three men and eight women from the Group B(c) 
indicated a marked burning pain upon application. The four people from the 
Group B(a) tried immediately to rub the test substance off the skin. 
In the case of eight men and nine women from the Group B(a), two women from 
the Group B(b) and two men from the Group B(c), focuses of inflammation 
occurred within the course of fifteen to thirty minutes, which were 
experienced as areas of pain and burning. 
These tests show that laurel oil with the melting point 36.degree. C. or 
40.degree. C. is incompatible on the skin diseased with psoriasis, tinea 
and eczemas, causes skin irritation and pain, and for this reason alone 
cannot be used as a therapeutic agent. 
(5) Skin compatibility tests of therapeutic agents according to the present 
invention on skin diseased with psoriasis, tinea and eczemas: 
Test Groups B(a), B(b), B(c); compositions A+C. 
Surprisingly enough, no skin irritations or other side effects were 
observed in this series of tests. 
(6) Therapeutic tests on skin diseased with psoriasis, tinea and eczemas: 
Test Groups C(a), C(b), C(c); compositions A, B, C, D. 
The compositions were applied three times daily to the test subjects on 
various diseased areas of the skin. For comparison, no treatment was 
undertaken on a fifth area of their skin, which was likewise erythematic. 
The patients guaranteed in writing that they would give up any further 
therapeutic treatment of their skin during the ten (10) week period of 
tests with the compositions according to the invention. 
The following results were evident after treatment: 
TABLE I 
______________________________________ 
Com- 
posi- 
tion Ca Cb Cc 
______________________________________ 
30 .male. 
50 .female. 
++ 2 .male. 
4 .female. 
++ 3 .male. 
2 .female. 
++ 
A 18 .male. 
14 .female. 
+ 7 .male. 
6 .female. 
+ 7 .male. 
6 .female. 
+ 
2 .male. 0 1 .male. 0 1 .male. 0 
- - 1 .female. 
- 
30 .male. 
48 .female. 
++ 2 .male. 
3 .female. 
++ 3 .male. 
2 .female. 
++ 
B 19 .male. 
15 .female. 
+ 7 .male. 
6 .female. 
+ 7 .male. 
7 .female. 
+ 
1 .male. 
1 .female. 
0 1 .male. 
1 .female. 
0 1 .male. 0 
- - - 
30 .male. 
48 .female. 
++ 2 .male. 
3 .female. 
++ 3 .male. 
2 .female. 
++ 
C 19 .male. 
14 .female. 
+ 7 .male. 
7 .female. 
+ 6 .male. 
6 .female. 
+ 
1 .male. 
2 + 0 1 .male. 0 2 .male. 
1 .female. 
0 
- - - 
+.male. 
45 .female. 
++ 2 .male. 
3 .female. 
++ 3 .male. 
2 .female. 
++ 
D 18 .male. 
14 .female. 
+ 7 .male. 
6 .female. 
+ 7 .male. 
7 .female. 
+ 
2 .male. 
5 .female. 
0 1 .male. 
1 .female. 
0 1 .male. 0 
- - - 
______________________________________ 
Key to symbols: 
++ = very marked improvement 
+ = still clear improvement 
0 = no noticeable reaction 
- = Worsening effect. 
TABLE II 
______________________________________ 
Good Effect No Effect 
Test Group ++and + 0 and - 
______________________________________ 
C(a) 442 14 
C(b) 74 6 
C(c) 73 7 
______________________________________ 
In none of the patients (except for one evident allergy to hydroxybenzoic 
acid esters) was there any appearance of subjective or objective side 
effects. 
The described test results show that the desired therapeutic effects can be 
achieved only with a pharmaceutical composition according to the present 
invention. 
ADDITIONAL CLINICAL EVALUATION 
Further, comparative treatments of psoriatic lesions with customary 
therapeutic medicaments and with topical application of the composition 
defined below were undertaken. That composition (I) was composed of: 
Coconut oil: 50 grams 
Palm kernel oil: 30 grams 
Laurel oil as defined in the German Pharmacopeia: 10 grams 
Emulsifier of equal parts of zinc stearate and lanolin: 10 grams 
This composition (I) was applied topically to sixty chronic clinical 
psoriasis patents for evaluation. To fifteen patients, there were also 
applied for side-by-side comparison, preparations which, according to the 
art, are customary antipsoriatically effective therapeutic medicaments. 
Those known medications evaluated were (1) a preparation based upon 
corticosteroids (Triamcinolone) and (2) a tar preparation based upon coal 
tar. 
In none of the fifteen patients under evaluation with the above 
compositions (1) and (2) did there occur a single exacerbation of the 
clinical condition compared with the control or comparative treatments. 
In twelve of the fifteen patients treated for twelve to fourteen days with 
the above-identified inventive composition (I), there occurred a 
surprising objectively visible lessening of the affliction, such that the 
affected body areas (mostly of the elbows and in the scalp area) were 
rendered completely normal. This was not thought possible by the patients, 
who for many years had used the customary medicaments for psoriasis. 
In the remaining 45 patients, no comparative therapeutic evaluation was 
undertaken. Each of these patients had in earlier years sought medical 
treatment for their affliction without any substantial improvement, 
although further advance of the affliction was delayed for some. 
In 38 patients, there occurred within from two weeks to two months an 
exfoliation of the diseased dermal tissue. Also, during the post-treatment 
period of three to eight months, there was no further occurrence of 
psoriasis on the previously afflicted dermal parts of these 38 patients. 
Thus the therapeutic efficacy of the compositions of the present invention 
has been established in comparison with treatments heretofore known, in 
which comparison the compositions of the invention were shown to be highly 
antipsoriatically effective.