DITHROCREAM Cream Ref.[27607] Active ingredients: Dithranol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Diomed Developments Ltd, T/A Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR

5.1. Pharmacodynamic properties

Dithranol has been used in the treatment of sub-acute and chronic psoriasis for over 70 years and, during that time it has become established as a safe and effective form of therapy. Its precise mode of action is still to be confirmed, although it has been shown to inhibit DNA replication, cellular respiration and key cellular enzymes eg glucose-6-phosphate dehydrogenase.

Because dithranol causes staining and irritation, it is now widely used in short contact therapy where the preparation is washed off the skin after periods of one hour or less. For this purpose, Dithrocream is particularly suitable, as it is convenient to apply and washes off easily in a bath or shower.

5.2. Pharmacokinetic properties

The traditional formulations of dithranol are based on soft paraffin from which it is effectively released into the skin. In Dithrocream, during manufacture, the oily paraffin phase of the cream is heated until the dithranol entirely dissolves so that, on cooling, it is retained solely within the paraffin phase and does not spread into the aqueous phase. After application of Dithrocream to the skin, the water is lost through absorption and evaporation, leaving the oily phase which then acts in the same way as a dithranol ointment. However, since the cream may be rubbed into the skin more effectively than the ointment, it is convenient to apply and, owing to the presence of the emulsifying components, is easier to wash off. The availability of the dithranol has now been confirmed in numerous publications detailing the results of clinical trials.

5.3. Preclinical safety data

No special information.

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