BACKGROUND: The therapy for skin diseases with topical glucocorticoids is limited by their local and systemic side effects. A glucocorticoid with an improved benefit-to-risk ratio is desirable. OBJECTIVE: A new topical corticoid, methylprednisolone aceponate (MPA) 0.1% ointment, was compared with the same formulation of mometasone furoate. METHODS: The two ointments were compared with respect to suppression of UVB light-induced erythema (n = 20) and with respect to atrophogenicity and appearance of telangiectasia (n = 20) in two double-blind trials with intraindividual comparisons in healthy volunteers. In a third trial, serum cortisol levels were measured in volunteers receiving extensive (60% of body surface) cutaneous application of MPA (n = 10) ormometasone furoate (n = 11). RESULTS:MPA and mometasone furoate were equally effective in suppressing UVB light-induced erythema. Atrophogenicity, as well as the incidence and severity of telangiectasia, were significantly more pronounced with mometasone furoate than with MPA. Both ointments decreased serum cortisol levels and did not differ significantly in this respect. However, the incidence of serum cortisol level suppression was higher in the mometasone furoate group than in the MPA group. CONCLUSION:MPA ointment has equal antiinflammatory activity and similar cortisol suppression but significantly fewer local side effects than mometasone furoate.
RCT Entities:
BACKGROUND: The therapy for skin diseases with topical glucocorticoids is limited by their local and systemic side effects. A glucocorticoid with an improved benefit-to-risk ratio is desirable. OBJECTIVE: A new topical corticoid, methylprednisolone aceponate (MPA) 0.1% ointment, was compared with the same formulation of mometasone furoate. METHODS: The two ointments were compared with respect to suppression of UVB light-induced erythema (n = 20) and with respect to atrophogenicity and appearance of telangiectasia (n = 20) in two double-blind trials with intraindividual comparisons in healthy volunteers. In a third trial, serum cortisol levels were measured in volunteers receiving extensive (60% of body surface) cutaneous application of MPA (n = 10) or mometasone furoate (n = 11). RESULTS:MPA and mometasone furoate were equally effective in suppressing UVB light-induced erythema. Atrophogenicity, as well as the incidence and severity of telangiectasia, were significantly more pronounced with mometasone furoate than with MPA. Both ointments decreased serum cortisol levels and did not differ significantly in this respect. However, the incidence of serum cortisol level suppression was higher in the mometasone furoate group than in the MPA group. CONCLUSION:MPA ointment has equal antiinflammatory activity and similar cortisol suppression but significantly fewer local side effects than mometasone furoate.
Authors: H Schäcke; T M Zollner; W D Döcke; H Rehwinkel; S Jaroch; W Skuballa; R Neuhaus; E May; U Zügel; K Asadullah Journal: Br J Pharmacol Date: 2009-05-06 Impact factor: 8.739