CLOBESOL ® Clobetasol

CLOBESOL ® is a drug based on Clobetasol propionate

THERAPEUTIC GROUP: Non-associated corticosteroids, dermatological preparations

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications CLOBESOL ® Clobetasol

CLOBESOL ® is indicated in the treatment of all skin disorders sensitive to corticosteroids, and generally resistant to other therapies.

Mechanism of action CLOBESOL ® Clobetasol

CLOBESOL ® is a drug that is particularly active against cutaneous inflammatory diseases thanks to the presence of Clobetasol, a synthetic corticosteroid with much more intense therapeutic activity than that of other corticosteroids such as Betamethasone.

In addition to the classic anti-inflammatory activity, carried out through the inhibition of the phlogistic cascade and the reduction of the synthesis of inflammatory mediators, Clobetasol was also effective in reducing the local concentration of mast cells, in contrasting the classical vasodilation that is observed during allergic events and inflammatory and thus ensuring a prompt remission of symptoms.

The aforementioned therapeutic properties are further supported by the good pharmacokinetic properties which allow to significantly limit the percutaneous systemic absorption of the topically applied active principle, thus reducing the risk of potential clinically relevant side effects.

Studies carried out and clinical efficacy

CLOBETASOL IN THE TREATMENT OF VITILIGINE

Dermatol Ther (Heidelb). 2013 Jun 4; 3 (1): 95-105. doi: 10.1007 / s13555-013-0028-8. Print 2013 Jun.

Study that demonstrates the ability of a Clobetasol-based skin foam to significantly improve the symptomatological manifestations present during vitiligo.

CLOBETASOL TOXICITY

Therapie. 2013 May-Jun; 68 (3): 179-81. doi: 10.2515 / therapie / 2013026. Epub 2013 Jul 26.

Case report that denounces the appearance of neuropsychiatric disorders following the incorrect use of Clobetasol proprionate, thus highlighting the danger of apparently harmless drugs.

Study that reaffirms the usefulness of the daily administration of Clobetasol in the topical treatment of psoriasis, highlighting the low efficacy of other therapeutic schemes such as the one every other day.

Method of use and dosage

CLOBESOL ®

Cream and ointment with 0.05% Clobetasol propionate.

Always according to medical indications, it is generally recommended to apply the appropriate quantity of medicine directly on the region affected by the lesion 1-2 times a day until the partial remission of the symptomatology.

Therapy can be prolonged, always according to medical judgment, reducing the doses used.

Usually CLOBESOL ® ointment is more indicated in the treatment of hyperkeratotic lesions while CLOBESOL ® in cream is indicated in the treatment of all localized lesions.

Warnings CLOBESOL ® Clobetasol

Medical consultation is a mandatory and necessary step in the treatment with CLOBESOL ® in order to assess the prescriptive appropriateness and thus limit the incidence of potential side effects.

However, the patient must play an active role in the treatment, taking care of:

avoid contact of the drug with eyes and mucous membranes;
avoid using the occlusive bandage;
avoid applying the medicine on large and severely damaged skin areas;
avoid prolonged use of the drug;
clean hands thoroughly after each application;
avoid direct exposure to ultraviolet radiation.

The above warnings together with the precautions to be used for hepatopathic and nephropathic patients allow to limit the adverse reactions associated with topical therapy with corticosteroids, supporting the efficacy of the therapy itself.

PREGNANCY AND BREASTFEEDING

The absence of studies able to better characterize the safety profile of topical Clobetasol for fetal and infant health and the presence of evidences that underline the toxicity of systemic corticosteroids for the unborn child, inevitably extend the aforementioned contraindications to use of CLOBESOL ® also to pregnancy and subsequent breastfeeding period.

Interactions

The low systemic absorption of the active ingredient that follows the topical use of CLOBESOL ® allows to significantly limit the risk of clinically relevant drug interactions.

However it would be appropriate to consider the ability of cytochromial system inhibitors to increase the half-life of the drug.

Contraindications CLOBESOL ® Clobetasol

The use of CLOBESOL ® is contraindicated in patients who are hypersensitive to the active substance or to one of its excipients, in patients under the age of 1 year and in patients suffering from serious bacterial and viral infections such as tuberculous, lactic and viral processes, acne rosacea, perioral dermatitis, perianal and genital itching and skin ulcers.

Undesirable effects - Side effects

Treatment with CLOBESOL ®, especially when prolonged over time, could expose the patient to the risk of local adverse reactions such as redness, burning, itching, dermatitis, atrophy, hypertrichosis, skin atrophy and rash.

Fortunately, systemic adverse reactions are rarer.