Method for the treatment of scars and keloids

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai

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514 55, 514 56, 514 62, 536 53, 536 20, 536 21, 536 552, 5361231, A61K 31715, C08B 3700

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active

057312982

DESCRIPTION:

BRIEF SUMMARY
This is in an application under 35 U.S.C. .sctn.371 of PCT/EP92/02990 having an international filing date of Dec. 24, 1992.


BACKGROUND OF THE INVENTION

The invention concerns a pharmaceutical composition for the treatment of wounds, scars and keloids.
Excess new growth of scar tissue occurs in many people during healing of skin wounds. In medical terminology this new formation of tissue is referred to as cicatricial hypertrophy or as keloid in severe cases. These are unpredictable reactions during wound healing caused by a predisposition. Up to now the reasons for excess cicatrisation are not known. Thus at present there is also no scientifically based causal method of treatment.
Numerous methods have been described for keloid treatment (cf. e.g. McCarthy/Convers "Plastic Surgery", volume 1, pages 732-747, W. B. Saunders, 1990). However, they are all more or less empirically based and do not have a secure foundation in a strict scientific sense. This is due on the one hand to a lack of basic knowledge and is also due to the fact that a spontaneous tendency of untreated keloids to regress is often observed.
As a consequence there is an extremely large number of competing methods of treatment whose effectiveness is, however, doubtful and of which the most important are briefly described in the following.
It is necessary to differentiate between mechanical (physical) and medicinal (chemical) methods of treatment.
The mechanical methods of treatment encompass the application of pressure on the keloid by external compression bandages and the application of foils made of silicon elastomers. A major disadvantage in this case is that the application has to be carried out over months and years. It can also not be used to the same extent in all body regions; thus for example an adequate degree of compression cannot be achieved on the neck. In addition extensive compression bandages always mean a considerable restriction in the freedom of movement and quality of life for the carrier. Moreover they also create considerable problems of hygiene, in particular in the warm period of the year and in hot countries. Compression bandages can also again lead to renewed tissue lesions by the mechanical strain on the sensitive scar skin and thus again promote keloid formation.
The physical methods also include cold treatment (cryotherapy) and laser therapy. Both methods produce tissue necroses by cold or heat by which means the active connective tissue cells and the fibrous substance within the keloid are destroyed. The keloids temporarily collapse and tissue defects are formed. During the subsequent healing of these defects, connective tissue cells again immigrate by which means the formation of keloid starts again. Consequently this method of treatment can thus always only achieve short-term improvements but no final healing.
In the case of the medicinal methods it is necessary to differentiate between preparations for external application and for injection.
In the case of the agents for external application, these are usually ointments with a great variety of active substances such as e.g. hormones, amino acids, mucopolysaccharides. Plant extracts such as from the thorn-apple are also used. A preferred component of preparations for the external treatment of scars and cicatricial keloids is heparin (cf. e.g. "Pharmazie in unserer Zeit" 10 (1981), page 168 to 181).
All preparations of active substances for external applications have the same inherent disadvantage, namely that the external application, i.e. spreading on the skin over the keloid, does not ensure an adequate tissue concentration in the keloid itself which can reach a thickness of up to several centimetres. Due to the excessively increased blood circulation within the keloids, the active substances--provided that they can penetrate the skin barriers at all--are rapidly transported away via the blood and lymph stream. The diffusion of the active substances in the tissue therefore only plays a subordinate role in the distribution.
It is also known that the active

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