Komfoderm M2, cream 10 g

Comfoderm® M2 is a combination drug with an effect due to its constituents.

Methylprednisolone aceponate is a nonhalogenated synthetic steroid.
When applied externally methylprednisolone aceponate suppresses inflammatory and allergic skin reactions associated with increased proliferation, which leads to reduction of objective symptoms of inflammation (erythema, edema, mucous) and subjective sensations (itching, irritation, pain, etc.). When methylprednisolone aceponate is used topically at the recommended dose, systemic effects are minimal in both humans and animals.

After repeated application of methylprednisolone aceponate on large surfaces (40-60% of the skin surface), as well as when used under the occlusive dressing no adrenal disturbances are noted: plasma cortisol levels and its circadian rhythm remain within normal limits, there is no reduction of cortisol concentration in daily urine.

Methylprednisolone aceponate (especially its main metabolite, 6α-methylprednisolone-17-propionate) binds to intracellular glucocorticoid receptors. The steroid-receptor complex binds to specific DNA sites of immune response cells, thus causing a series of biological effects.

In particular, binding of the steroid-receptor complex to the DNA of the immune response cells leads to induction of macrocortin synthesis. Macrocortin inhibits the release of arachidonic acid and thus the formation of inflammatory mediators such as prostaglandins and leukotrienes.

Inhibition by glucocorticosteroids of vasodilatory prostaglandin synthesis and potentiation of vasoconstrictor effect of adrenaline lead to vasoconstrictor effect.

Urea has keratolytic and moisturizing effects. Urea promotes water binding and consequently softens the horny layer of the skin. In addition to its keratolytic effect, urea has proteolytic activity.

Pharmacokinetics

Methylprednisolone aceponate is hydrolyzed in the epidermis and dermis when applied topically. The main and most active metabolite is 6α-methylprednisolone-17-propionate, which has a significantly higher affinity for glucocorticosteroid receptors in the skin, indicating the presence of its “bioactivation” in the skin.

The extent of percutaneous absorption depends on the condition of the skin and the route of application (with or without an occlusive dressing).

The percutaneous absorption in patients with atopic dermatitis (neurodermatitis) and psoriasis is not more than 2.5%, which is only slightly higher than that in healthy volunteers (0.5-1.5%).
After entering the systemic bloodstream 6α-methylprednisolone-17-propionate rapidly conjugates with glucuronic acid and is thus inactivated.

Methylprednisolone aceponate metabolites are eliminated mainly by the kidneys with a half-life of about 16 hours. Methylprednisolone aceponate and its metabolites do not cumulate in the body.
Due to the low absorption capacity of urea when used topically, there is little chance of systemic effects.

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