A pharmaceutical composition comprises a synergistic combination of about 0.01-0.15% by wt. triamcinolone acetonide and about 0.04-0.3% by wt. halcinonide as active ingredients, in combination with a pharmaceutically acceptable carrier.
A pharmaceutical composition comprises a synergistic combination of at least about 0.01% by wt. triamcinolone acetonide and at least about 0.01% by wt. halcinonide as active ingredients therein, in combination with a pharmaceutically acceptable carrier.
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2. A pharmaceutical composition comprising about 0.1% triamcinolone acetonide and about 0.1% halcinonide in combination with a pharmaceutical carrier.
1. A pharmaceutical composition comprising triamcinolone acetonide and halcinonide in synergistic and effective amounts in combination with a pharmaceutically acceptable carrier.
4. A pharmaceutical composition comprising triamcinolone acetonide and halcinonide in synergistic and effective amounts in combination with one or more of petroleum jelly, lanoline, and lanet wax.
6. A pharmaceutical composition comprising about 0.1% triamcinolone acetonide, about 0.1% halcinonide, about 45 to 50% vaseline, about 6.5 to 7.5% lanoline, about 12 to 15% lanet wax, and a remainder of water, wherein, the percent values are characterized by weight.
3. A pharmaceutical composition according to
7. A method for treating psoriasis in a patient comprising topically administering a composition of
8. A method for treating psoriasis in a patient comprising topically administering a composition of
9. A method for treating psoriasis in a patient comprising topically administering a composition of
10. A method for treating dermatitis in a patient comprising topically administering a composition of
11. A method for treating dermatitis in a patient comprising topically administering a composition of
12. A method for treating dermatitis in a patient comprising topically administering a composition of
13. A method for treating eczema in a patient comprising topically administering a composition of
14. A method for treating eczema in a patient comprising topically administering a composition of
15. A method for treating eczema in a patient comprising topically administering a composition of
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DESCRIPTION OF DRAWINGS
FIGS. 1A and 1B are photographs taken of a patient suffering from severe psoriasis, before treatment with a composition according to the present invention;
FIGS. 1C and 1D are photographs taken of the same patient three months after treatment.
FIGS. 2A and 2B are photographs take of a patient suffering from allergic eczema before treatment with a composition according to the present invention;
FIGS. 2C and 2D are photographs taken of the same patient three weeks after treatment.
FIGS. 3A and 3B are photographs taken of a patient suffering from atopic eczema before treatment with a composition according to the present invention and two weeks after treatment.
FIGS. 4A and 4B are photographs taken of a patient suffering from severe dermatitis of the foot before treatment with a composition according to the present invention, and ten days after treatment respectively.
FIGS. 5A and 5B are photographs taken of a patient suffering from severe eczema of the hand before treatment with a composition according to the present invention.
FIGS. 5C and 5D are photographs taken of the same patient two weeks after treatment.
FIGS. 6A, 6B and 6C, are photographs taken of a patient suffering from severe psoriasis before treatment, 1 week into treatment, and 3 weeks after treatment with a composition containing a total of 0.2% active ingredients applied to one side of his body, according to the present invention.
FIGS. 6D, 6E and 6F are photographs taken of the same patient of FIGS. 6A, 6B and 6C before treatment, 1 week into treatment, and 3 weeks after treatment with a composition containing a total of 0.04% active ingredients applied to the other side of his body, according to the present invention.
FIGS. 7A, 7B and 7C are photographs taken of the right leg of a patient suffering from eczema taken before treatment, 1 week into treatment and 3 weeks into treatment with a comparative composition containing 0.2% tiamcinolone acetonide as the sole active ingredient.
FIGS. 7D, 7D, and 7F are photographs taken of the left leg of a patient suffering from eczema taken before treatment, 1 week into treatment, 3 weeks into treatment and 4 weeks into treatment with a composition according to the present invention containing 0.1% halcinonide and 0.1% triamcinolone acetonide as combined active ingredients therein.
FIGS. 8A and 8B are photographs of an infant suffering from infant dermatitis before treatment; and
FIGS. 8C and 8D are pictures of the same infant taken 2 months later after treatment with a composition according to the present invention.
In the following examples and referring to FIGS. 1A-8D, compositions according to the present invention containing 0.1% halcinonide and 0.1% triamcinolone acetonide were used except where otherwise indicated.
Two compositions according, to the present invention were prepared in the following manner:
Preparation of the Base
Vaseline® (490 g) was mixed with lanolin (70 g) and lanet wax (140 g) was added while heating at a temperature not exceeding 70° C. and mixing constantly in order to maximize the homogenicity of the base. 300 g water was added at 70°C
Active Ingredients
1a) Per 100 g ointment--200 mg halcinonide --100 mg triamcinolone
1b) Per 100 g ointment--300 mg halcinonide --100 mg triamcinolone (Forte-extra strength formulation)
The above amounts of active ingredients were respectively mixed together with a mortar and pestle with the help of a drop of paraffin. While mixing constantly the base was added drop by drop at first, then more rapidly, until a total amount of 100 gm was obtained.
a) A comparative composition was prepared as in Example 1, however having only 0.01% halcinonide and 0.01% triamcinolone acetonide in the final composition.
b) A comparative composition was prepared as in Example 1, having 0.3% halcinonide as sole active ingredient.
c) A comparative composition was prepared as in Example 1, having 0.3% triamcinolone acetonide as sole active ingredient.
A volunteer patient having severe psoriasis over the entire body was treated at different sites with compositions 1a, 1b and comparative compositions 2a, 2b and 2c by application of minor equal amounts massaged into effected areas twice a day for a three week period.
The observed results were as follows:
Composition 2a--Some spots of the psoriasis disappeared, but not all, and where they did fade, pink color remained.
Composition 2b--No lasting results--no appreciable improvement.
Composition 2c--No lasting results--no appreciable improvement.
Composition 1a--Within one week of treatment the psoriasis on the entire area of treatment disappeared with skin returning to normal color except for a few isolated spots of original long established psoriasis. (These spots also disappeared upon treatment with composition 1b) nd .
Composition 1b--Within one week of treatment the spots completely disappeared with skin returning to normal color and with no sign of previous psoriasis.
It should be noted that this experiment was performed on a subject with a severe case of psoriasis covering parts of the entire body and that while the prior art formulations in their maximum permitted dose had no appreciable effect, the compositions of the present invention effected a complete removal of all external manifestations of the psoriasis which lasted for over a one year period before the recurrence of the condition.
Over 1600 volunteer patients suffering from psoriasis, atopic eczema, allergic eczema, rosacea, and other similar dermatological conditions were treated with compositions according to the present invention.
The patients were instructed to apply the composition twice a day for a period of between 2 and 4 weeks, morning and evening until all external manifestations disappeared, and then the composition was applied once a day for an additional period of 1 week. A very small amount was used each time, massaged very well into the skin.
In this extended testing it was found with regard to psoriasis patients that approximately 5% had no recurrence even after eight years approximately 40% had no recurrence for a period in excess of twelve months and another approximately 40% had no recurrence for a period in excess of six months. In those volunteers in which a recurrence was noted, application of the composition according to the present invention once again affected a removal of all external manifestations for an extended period of time.
Among the sixteen hundred volunteers tested were people suffering from psoriasis, eczema of different types, causes and severity as well as people suffering from rosacea, and dermatitis of different types, causes and severity.
While not sufficiently tested under controlled conditions, it has been reported by volunteer patients that the composition of the present invention was also effective in treating sores associated with herpes simplex, pain associated with arthritis, even when said arthritis was not associated with psoriasis and bursitis.
Referring to FIGS. 1A and 1B, there is seen a volunteer patient who reported having had suffered from severe psoriasis for over twenty years with extensive lesions on his chest, stomach and arms.
After three weeks of treatment with the composition of the present invention, the lesions had disappeared. The patient returned and was photographed after three months and the results are seen in FIGS. 1C and 1D. As illustrated, only minor discolorations and scaring from the original severe psoriasis appear, while the skin is totally clear of active sores and lesions.
Referring to FIGS. 2A and 2B, there is seen a young boy who is allergic to eggs, citrus fruits, chocolate, nuts, fish, tomatoes, ketchup, strawberries and other food products which all give him allergic eczema, from which he has suffered all his life. As illustrated in these pictures, the boy's arms and stomach are covered with eczema spots and sores.
This volunteer patient was treated with a composition of the present invention and his mother reported that after for days 80% of his rash had disappeared, as had the accompanying itching feeling. After ten days the entire rash was gone.
FIGS. 2C and 2D are photographs taken 21/2 weeks after commencement of treatment and, as can be seen, the skin is completely clear of all rash and sores.
FIG. 3A is a photograph of the hands of a dishwasher, suffering from atopic eczema, whose fingers were swollen and chapped and even infected. He had used cortisone creams over a period of over five years, ranging in prescriptions of 1% to 3% without relief. After two weeks of treatment with the composition of the present invention, the swelling, infection and chapping had all disappeared as shown in FIG. 3B.
FIG. 4A is a photograph of the foot of a volunteer patient suffering from dermatitis. As can be seen, his foot is dry and scaly with scabs and sores. FIG. 4B is a photograph of the same patient taken only ten days later, after treatment with a composition of the present invention. As can be seen, the foot exhibits a marked improvement, being free of scales, scabs and sores and having returned to almost a normal color, which was achieved after an additional one week of treatment with the composition of the present invention.
FIGS. 5A and 5B are photographs of a 41/2 year old boy suffering from severe eczema of the hands. As can be seen his hands and tips of the fingers are covered with scales, sores, scabs and white lesions, and patches are even hanging from his finger tips. His mother advised that he had suffered from this condition all his life, and that treatment with cortisone and other recommended creams did not remove this condition.
After 2 weeks of treatment with a composition of the present invention the hands are completely free and clean of all sores and scabs, as can be seen in FIGS. 5C and 5D.
The same patient who suffered severe psoriasis and was treated in 1988 as discussed with reference to FIGS. 1A-1D, suffered a recurrence of the condition and agreed to try two different formulations of compositions according to the present invention on the two sides of his body.
As indicated hereinbefore, FIGS. 6A, 6B and 6C are photographs taken before treatment, 1 week into treatment, and 3 weeks after treatment with a composition containing a total of 0.2% active ingredients applied to one side of the body, while FIGS. 6D, 6E and 6F are photographs taken of the same patient of FIGS. 6A, 6B and 6C before treatment, 1 week into treatment, and 3 weeks after treatment with a composition containing a total of 0.04% active ingredients applied to the other side of the body.
As will be noted from FIGS. 6A and 6D, on Apr. 28, 1995, both sides of the body and both arms exhibited large patches of encrusted lesions. As can be seen from FIGS. 6B and 6E, already on May 1, 1995, a major improvement is noted wherein the encrusted lesions have disappeared and there remain only milder red patches. Referring now to FIGS. 6C and 6F, 31/2 weeks after treatment, even the red patches have disappeared leaving only mild discolorations, both on the side treated with a diluted composition containing only 0.02% triamcinolone acetonide and 0.02% halcinonide, As can be seen, there is no appreciable difference to the visible eye between the effect of these compositions of different dosages according to the present invention.
A further comparative test was carried out on a patient suffering from eczema on extensive parts of her body. This patient was instructed to apply three creams to different parts of her body without being told the content of the various creams. The first cream contained 0.2% triamcinolone acetonide, and was applied to the right leg with the results being shown in FIGS. 7A, 7B and 7C. The second cream contained 0.2% halcinonide and was applied to the left leg with the results being shown in FIGS. 7D, 7E and 7F. The third cream contained a combination of 0.1% triamcinolone acetonide and 0.1% halcinonide and was applied to the arms with the results being shown in FIGS. 7G, 7H, 7I and 7J.
The volunteer patient reported having severe atopic eczema since birth, having used cortisone creams over long periods for the last 36 years, without relief from the rash and itching which accompany this condition.
Referring to FIGS. 7A, 7D and 7G, the itchy scabby sores on the arms and legs of the patient are quite evident. Referring to FIGS. 7B, 7E and 7H, it can he noted that one week after treatment the sores still remain, however are much milder.
The major difference between the three creams becomes evident however, three weeks into treatment, wherein the sores are almost completely gone on the arms of the patient, as can be seen from FIG. 7I, however, have returned and begun to be even worse on both legs of the patient, as seen in FIGS. 7C and 7F when compared to FIGS. 7B and 7E.
The patient also reported that in all areas that were treated with cream c, the skin had become better and better, but in the areas that were treated with a and b, the rash began to return and was resistant to the treatment and small open sores reformed on the skin.
At this point and time, the patient refused to continue using creams a and b, and switched to the use of cream c (which is the cream according to the present invention), on all parts of her body.
FIG. 7J shows the arms of the patient clear of all sores after less than one month of treatment and the patient reported that the rash is completely gone, the sores are completely gone, and the skin is continuing to improve and be softer and more supple every day.
Referring now to FIGS. 8A and 8B there are seen photographs of an infant suffering from severe infant dermatitis before treatment and having extensive red rash areas on both the front and back of his body.
FIGS. 8C and 8D are pictures of the same infant taken 2 months later after treatment with a composition according to the present invention, and as can be seen, the body is almost completely clear of the original rash.
While this invention has been particularly shown and described with references to preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims.
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| Feb 23 2005 | MASSA TECHNOLOGY S A | PSORIAID S A | CHANGE OF NAME SEE DOCUMENT FOR DETAILS | 016274 | /0741 |
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