Clinical study of the relationship between dose and response to halopredone acetate in dermatoses

Abstract

A comparative clinical investigation with three different concentrations of 17,21-bis(acetyloxy)-2-bromo-6beta,9-difluoro-11beta-hydroxypregna-1,4-diene-3,20-dione (halopredone acetate; Topicon), a new topical corticosteroid, has been made to assess the optimum concentration of active substance to be incorporated into cream on the basis of the therapeutic effects achieved in dermatologic patients. The remarkable therapeutical effectiveness of the new steroid, however, has made it impossible to ascertain statistically significant differences between preparations containing either 0.01%, 0.025% or 0.05% of active substance, and to gain thereby a clear answer concerning the relationship between dose and response. Numerous haematochemical controls were made during the trials. In particular, we determined the plasma cortisol levels in patients suffering from large lesions requiring prolonged occlusive medication. No significant alterations of the basal values were observed. As already observed in animals, halopredone, acetate is devoid in humans also of the wellknown effects on the hypophysial-adrenal axis due to transcutaneous absorption of steroids.