Drug – bio-affecting and body treating compositions – Containing designated ingredient to reduce noxious effects...
Reexamination Certificate
2000-11-27
2003-06-24
Padmanabhan, Sreeni (Department: 1619)
Drug, bio-affecting and body treating compositions
Containing designated ingredient to reduce noxious effects...
C514S558000, C514S559000, C514S560000, C424S725000
Reexamination Certificate
active
06583184
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to the use of comfrey. More particularly, the present invention relates to the use of comfrey to ameliorate, prevent, reduce and/or treat irritation caused by topical compositions having a retinoid or a retinoid compound.
2. Description of the Prior Art
Retinoid or retinoid compounds/derivatives (collectively referred to herein as “retinoid” or “retinoids”) are vitamin A derivatives. They are used in topical compositions to treat a variety of adverse skin conditions. Such skin conditions include acne, actinic damage, fine lines, wrinkles, warts, psoriasis, dandruff and eczema. Representative compositions having a retinoid are discussed, by way of example, in U.S. Pat. Nos. 3,006,939; 3,060,229; 3,932,665; 4,826,828; and 4,934,114.
However, topical compositions having a retinoid have been limited by way of the amount of retinoid since retinoid contained in the composition has been found to irritate the skin. Such irritation is acute especially when the amount of retinoid in the composition is high. However, some consumers with sensitive skin cannot even tolerate small amounts of retinoid.
The irritation can manifest itself in the form of physical discomfort and/or unaesthetic skin appearance. Such an unaesthetic skin appearance can progress to dermatitis or erythema. The irritation may disturb the user to such an extent that the user will discontinue use of the composition having a retinoid. Alternately, the user may reduce the frequency of use, thereby possibly reducing the effectiveness of the composition for its intended purpose.
Known prior art provides natural and synthetic substances, such as cortisone derivatives, that are useful anti-inflammatory agents in topically applied skin compositions. Such substances are discussed, by way of example, in U.S. Pat. Nos. 5,962,018; 6,008,246; and 6,020,367; and International Application (WO) Nos. 9739726; 9746231; 9848768; and 9850005. However, none of these patents or published applications points out a non-cortisone, anti-inflammatory agent that is particularly suited for reducing skin irritation induced by a retinoid in a topical cosmetic composition.
U.S. Pat. No. 5,578,312 to Parrinello is directed to a skin care system and method To improving the moisture retention in skin, particularly for individuals who are undergoing treatment for life threatening illnesses. As stated in column 2, lines 4.6, et seq., a second embodiment of the moisturizer includes vitamin A and allantoin. Column 4, lines 63 et seq. states that comfrey leaf Contains allantoin. However, this is very specifically directed to a tea solution. Moreover, based upon the specific gravity values of most commercially available Vitamin A materials, all of the exemplified formulas disclose a Vitamin A concentration greater than 1.0 wt. %.
A commercial cosmetic product sold by Avon Products, Inc. under the name Daily Revival contained retinyl palmitate and comfrey. However, the retinyl palmitate was not present in a skin irritating amount, nor was the product used for the treatment or prevention of skin irritation of any kind.
Heretofore, there has been a need for a composition that ameliorates, prevents, reduces and/or treats the irritation induced by a retinoid. It has been found that retinoid-induced irritation has a direct correlation to retinoid efficacy. Thus, simply reducing retinoid content may decrease irritation to the skin, but may also fail to provide an efficacious amount of retinoid. Moreover, consumers with sensitive skin needs may hot tolerate even reduced retinoid content compositions. However, these sensitive skin consumers require, and would benefit from, a retinoid-containing composition that is both tolerated and efficacious. The present composition having comfrey achieves this need.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a topical composition having comfrey to treat, ameliorate and/or reduce or prevent skin irritation induced by a retinoid.
It is a further object of the present invention to provide a method for treating, that is ameliorating and/or reducing, skin irritation induced by a retinoid.
It is still a further object of the present, invention to provide a method for preventing irritation induced by a retinoid.
These and other objects of the present invention are achieved by a topical composition that has comfrey in an amount effective to prevent and/or treat skin irritation induced by a retinoid.
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to the surprising recognition that comfrey has a direct effect in mitigating skin irritation induced or caused by the topical use of a retinoid. It has been discovered that comfrey will treat, namely ameliorate and/or reduce, such irritation. It has also been discovered that comfrey will prevent such irritation. The efficacy of the retinoid in a topical composition will not be adversely affected by the addition of comfrey to the composition.
As stated above, retinoids are Vitamin A derivatives. Commonly used retinoids include, but are not limited to, retinal, retinol, retinoic acid, retinyl acetate, retinyl palmitate, retinyl propionate, isotretinoin, synthetic retinoid mimics, and tretinoin. The amount of retinoid in a topical composition varies depending on the condition to be treated or prevented, as well as on the composition and the retinoids themselves. However, for most conditions to be treater or prevented, the amount of retinoid in any composition is about 0.1 percentage by weight (wt %); but no greater than about 1.0 wt %, preferably no greater than about 0.5 wt %, since this amount is associated with some irritation and is always irritating to users with sensitive skin.
The comfrey of the present invention may be derived from any part of the comfrey plant (preferably,
Symphytum officinale
) These parts include the flowers, leaves, roots, seeds and stems. Preferably, the comfrey is extracted from the leaves and roots of the plant. The comfrey extract may be in the form of a liquid or powder. A suitable example of a comfrey extract is available from Cosmetochem under the tradename HERBASOL™. It is an extract obtained from comfrey herbs in approximately 60:40 v:v water in propylene glycol solution. It is about 3.5% to 5.5% active.
Comfrey should be present in the topical composition of the invention in an amount, on an active basis, of at least about 0.005 wt % based on the total weight of the composition to treat retinoid-induced skin irritation. Preferably, comfrey is present in an amount at least about 0.005 wt %. to about 90 wt %, more preferably about 0.01 wt % to about 25 wt %, and most preferably about 0.01 wt. % to about 1.0 wt. % based on the total weight of the composition.
As a guideline, it is preferred that when the retinoid is retinol, the amount of comfrey to retinol ratio is from about 1:5 to about 10:1, more preferably from about 1:4 to about 5:1, or most preferably from about 1:3 to about 5:1.
It should be understood that the effect produced by a retinoid will vary by the type and amount of retinoid used in the topical composition. Accordingly, those skilled in the art will vary the amount to compensate for the various efficacies and concentrations associated with each retinoid, as well as the efficacy of the vehicle used. For example, drying vehicles, such as anhydrous gels, are generally considered to increase the potency/irritation of the retinoid as compared to emollient vehicles, such a oil-in-water creams.
The present invention functions against the irritating effect of a retinoid. As is known in the art, potencies of different retinoids vary. For example, retinoic acid is known to be more potent/irritating than retinol. In contrast, retinyl palmitate is known to be less potent than retinol. For this reason, retinyl palmitate is known to produce less irritation compared to retinol on a weight to weight basis. In fact, when retinyl palmitate is employed in commercial skin care products, there is virtually no irritation associate
Avon Products Inc.
Ohlandt Greeley Ruggiero & Perle L.L.P.
Padmanabhan Sreeni
Willis Michael A.
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