Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined... – Embryonic structure
Reexamination Certificate
2001-05-07
2003-12-09
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Extract, body fluid, or cellular material of undetermined...
Embryonic structure
Reexamination Certificate
active
06660305
ABSTRACT:
TECHNICAL SECTOR
This invention relates to the field of human medicine, more specifically to dermatology, and in particular to a composition developed for stimulating the synthesis of the melanic pigment of the skin, therefore useful in the treatment of vitiligo, as well as the procedure for obtaining that composition.
PRIOR ART
Vitiligo or leukoderma is one of the oldest known diseases of humanity, and is characterized by the loss of the cells that produce melanic pigment in the skin. This disease affects approximately 1% of the world's population, without distinction as to age, sex or race. It is of unknown etiology and no treatment has been found for it up to now. It appears as a gradual depigmentation of the skin of patients who are in situations of extreme nervous tension, and has an unfavorable affect on their psyche and social behavior as its external symptoms emerge, appearing as white areas of skin surrounded by a halo of hyperpigmentation, and manifesting themselves primarily on the face, trunk and around the joints.
Current technology recognizes that certain chemical substances of vegetable origin or produced semi-synthetically, known as psoralens, can be used in the treatment of vitiligo. These substances, administered orally or topically, concentrate in the melanocytes or cells that produce the dermic pigment, absorbing energy from ultraviolet radiation and stimulating the production of the pigment melanin. (Arnold, M. J. Jr. “Psoralens and Suntan,” Hawaii Med. J., 1957-16391); (Becker, S. W. Jr. “Methods of Increasing Skin Pigmentation,” J. Sec. Cosmetic Ehem., 1958-9-80); (Fitzpatrick, T.B. “Pigmentary Diseases,” Current Therapy, 1958-314); (Becker, S. W. Jr. “Effects of 8-Methoxy Psoralen and Ultraviolet Light in Human Skin,” Science, 1958-127-878); (Sidi, E. Planat, P. “Practical Considerations on Current Treatment of Vitiligo,” Revue of Medicine, Dec. 23, 1968).
However, psoralens are not without toxic secondary effects, being capable of causing dermatitis and necrosis of the skin when applied topically. Furthermore, their effect is slow and reversible in the majority of cases when the medication is discontinued. In addition, these substances present some difficulties in application, which requires a gradually increasing daily period of ultraviolet radiation exposure for the patient, sometimes provoking severe toxic reactions such as burns resulting from their topical application, or hepatic insufficiency, digestive, renal and nervous disturbances from their oral administration.
The currently known technical solution that is most similar to this invention is Melagenina Lotion®, Patent FR 8220746. Melagenina Lotion® is a 50% human placenta alcoholic extract, which is obtained from healthy pregnant women under aseptic conditions after normal childbirth. This extract contains a lipoprotein with a molecular weight between 1500 and 4000 Daltons, which constitutes its active element. This substance stimulates the reproduction of the melanocytes and the synthesis of the melanic pigment, also accelerating the oxidation of the amino acid L-dopa in the presence of sunlight, which encourages its transformation into melanin after internal chemical processes.
Melagenina Lotion® has been used successfully for the treatment of vitiligo up to now. According to clinical trials that were performed, its use was noticeably effective among all the patients to whom it was applied. (Miyares Cao C., Taboas M. and López H. “Informe preliminar sobre el empleo de extracto placentario humano en la terapeutica del Vitiligo,” [Preliminary Report on the Use of Human Placenta Extract in the Treatment of Vitiligo] Revista Cubana de Farmacia 10 (1). 1976; Miyares Cao C. et al. “Estudio experimental y clinico del efecto pigmentante epidermico del extracto placentario humano,” [Experimental and Clinical Study of the Epidermal Pigmenting Effect of Human Placenta Extract] Revista Cubana de Farmacia, Volume 20, No. 6, November-December 1981; Sharma S. K.,. Jain R. K and Sharma A. K. “Topical Human Placental Extract for the Treatment of Vitiligo, A Preliminary Study”; Miyares C. et al., “Estudio experimental y clinico del efecto pigmentante epidermico del extracto placentario humano,”[Experimental and Clinical Study of the Epidermal Pigmenting Effect of Human Placenta Extract] Annais Brasileiros de Dermatologia, 1986: 61: 3 (Supplement); Miyares Cao C. “Melagenina Producto Cubano. Nuevo y Eficaz medicamento para el tratamiento del Vitiligo,” [The Cuban Product Melaginina. A New and Effective Medication for the Treatment of Vitiligo] Serie de Resenas Nacionales, Ed. Palacio de las Convenciones. Havana, p. 15. 1986).
Melagenina Lotion®, although free of harmful side effects, is a product that must be used in three daily applications at 8-hour intervals and accompanied by sun or infrared exposure at one of the applications, which makes it difficult for many of the patients to complete the treatment.
Current technology also recognizes that calcium actively participates in the process of skin pigmentation, through the stimulation of the secreting action of the melanocytes in proportion to the concentration of this ion. (Meyer, A. 1986. “Influence of Calcium on the Melanocytes in the Inner Ear,” Abst; 13th International Pigment Cell Conference Oct. 5-6, Tucson, Ariz., USA; and Negishi, S. 1986. “The Role of Calcium in Light Response of Onyzias Melonophores,” Abst; 13th International Pigment Cell Conference Oct. 5-6, Tucson, Ariz., USA).
REFERENCES:
patent: 4507277 (1985-03-01), Cao et al.
patent: 5690966 (1997-11-01), Bhadra et al.
patent: 6451358 (2002-09-01), Zhao
Prajnamoy et al., Intl J of Dermatology (1995); 34(1): 61-66,. Hydroalcoholic human placental extract: Skin pigmenting activity and gross chemical composition.*
Schallreuter et al., Dermatology (1995); 190: 223-229. Treatment of vitiligo with a topical application of pseudocatalase and calcium in combination with short-term UVB exposure.*
Carsberg et al., J Dermatological Science (1995); 9:157-164. Intracellular calcium modulates the responses of human melanocytes to melanogenic stimuli.
Centro de Histoterapia Placentaria
Flood Michele C.
Lackenbach & Siegel LLP
Tate Christopher R.
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