Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined... – Derived from arthropod
Reexamination Certificate
2003-03-10
2004-10-12
Lankford, Jr., Leon B. (Department: 1651)
Drug, bio-affecting and body treating compositions
Extract, body fluid, or cellular material of undetermined...
Derived from arthropod
C424S520000
Reexamination Certificate
active
06803056
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a method and composition for the treatment of lesions associated with viral infections, such as Herpes simplex or Herpes zoster.
BACKGROUND OF THE INVENTION
Herpes viral infections are chronic. Once the virus enters the body, it lies dormant in the nerve cells and periodically reactivates. When the virus reactivates, it characteristically causes a sore at the site where it first entered the body. To date, there is neither a vaccine to prevent the Herpes infection, nor any way to eliminate the virus from the body. Once infected, the patient has the virus for life.
Recurrent outbreaks of the Herpes virus generally follow a staged progression. The stages are easily identifiable and include prodrome, vesicles, ulceration, crust and healing. Some of these stages can last less than 24 hours. Prodrome is generally a short period of tingling, itching, numbness or burning with no visible sign of an outbreak. Vesicles is the formation of one or more fluid-filled blisters, often in a cluster and usually surrounded by sore, red skin. The ulceration stage is when the blisters open to form painful ulcers or open sores. At the edge of the sore, a soft or hard yellow crust begins to appear. Ulcers and painful, sore, red skin persist through this stage. At the crust stage, weeping sores or ulcers become completely covered by a crust or scab. No ulcers or blisters are present. The healing process is manifested by disappearance of the crust, swelling, pain and itching. Skin eruptions due to viral infection, especially Herpes viruses, generally have a normal infective course that lasts from 10 to 60 days depending on the exact causative species and anatomical location of the infection.
Propolis has been used in both water-based and oil-based preparations to treat viral outbreaks. Propolis preparations are reported to reduce the healing process by up to 50% or from an average of 9 to 10 days to an average of 4 to 5 days. In a placebo-controlled study involving 50 patients with recurrent oral Herpes, a commercial petroleum-based propolis ointment (Herpestat or HelaStop) reduced healing time by 50%, Szmeja and Konopacki,
Otolaryng. Pol.,
XLI(3): 183-188 (1987). The average healing time for the placebo patients was 8 days and the average healing time for patients using Herpestat, which is also called Herstat, was 4 days. The same results were reported for a placebo controlled study using a commercial aqueous propolis extract solution, Nivcrisol-D Giurcaneanu et al.,
Virologie,
39(1):21-24 (1988). This study involved 65 patients. Patients using placebo had an average healing time of 8 days and those using Nivcrisol-D, an average healing time of 4 days.
In a placebo controlled study involving 90 patients with recurrent genital Herpes, the efficacy of acyclovir ointment and a petrolatum based propolis ointment (HelaStop) were compared. The average healing time for both the placebo and acyclovir ointment was 12 days and an average healing time for the propolis ointment group was 8-9 days, Vynograd et al.,
Phytomedicine,
7(1):1-6 (2000). In Table 3 of Vynograd eta, it is reported that of 30 patients treated with a propolis preparation, none had healed Herpes lesions after three days, only 10 had healed after seven days and 24 had healed after ten days.
Busciglio, U.S. Pat. No. 4,748,022 discloses compositions comprising diphenhydramine HCl, lidocaine HCl, aloe vera gel and propolis in a formulation having a basic pH. In the comparative data, while the composition containing all ingredients was superior to a similar formulation without the aloe vera gel and propolis, a formulation omitting only propolis demonstrated about 40% better average healing time than the formulation containing all ingredients. It should be noted that one subject reported no healing with the formulation omitting propolis. Regardless, the results must be viewed as inconclusive in terms of the capacity of the formulation ingredients to enhance the efficacy of propolis.
It is evident from these results that there is still a need for an effective treatment. It has been found that by using propolis in the compositions of the present invention, the healing time of Herpes outbreak is dramatically reduced to 36-48 hours and material progression of the outbreak is prevented beyond the stage of progression at the time of the initial application.
SUMMARY OF THE INVENTION
The present invention relates to topical preparations and methods for treatment of skin and mucosal membrane lesions associated with viral infections, such as Herpes simplex or Herpes zoster. More specifically, the present invention provides a composition and method for the treatment of lesions associated with Herpes viruses that reduces the healing time of a Herpes outbreak and stops the outbreak on contact with full healing, generally in 36 to 48 hours.
In particular, the present invention provides a composition for the treatment of lesions associated with viral infections comprising: propolis extract, a skin protectant, a penetration enhancing agent and an emulsion base. The present invention also provides a method for the treatment of lesions associated with viral infections comprising applying to the lesion an effective amount of the subject compositions.
REFERENCES:
patent: 4699791 (1987-10-01), Tabord
patent: 4748022 (1988-05-01), Busciglio
patent: 5449794 (1995-09-01), Markonius
patent: 5591771 (1997-01-01), Markonius
patent: 5861430 (1999-01-01), Markonius
patent: 5977176 (1999-11-01), Wise et al.
patent: 6027716 (2000-02-01), Levin et al.
Szmeja et al.,Otolaryng. Pol., XLI(3) pp. 183-188 (1987).
Giurcaneanu et al.,Virologie,39(1), pp. 21-24 (1988).
Vynograd et al.,Phytomedicine7(1) pp. 1-6 (2000).
Villanueva et al.,Annals Inst. Pasteur Paris118(1), pp. 84-87 (1970).
Schneiderweind et al.,Pharmazie,30(12), p. 603 (1975).
Park et al.,Biosci. Biotechnol. Biochem.,62(11) pp. 2230-2232 (1988).
Markham et al.,Phytochemistry42(1), pp. 205-212 (1996).
Pepeljnjak et al.,Pharmazie40(2) pp. 122-123 (1985).
Gibbons, Del Deo, Dolan Griffinger and Vecchione
Lankford , Jr. Leon B.
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