Comparison of the Dermal Toxicity of four Antimicrobial-Steroid Cream Combinations in the Rabbit

Abstract

The dermal toxicity of four antimicrobial-steroid cream formulations, tolnaf-tate 1%/hydrocortisone 0.5% (TH), clotrimazole 1%/hydrocortisone 0.5% (CH), clotrimazole 1%/betamethasone 0.06% (CB), and clotrimazole 1%/gentamkin 0.1%/betamethasone 0.05% (CGB), was compared in separate studies. All cream formulations were applied to the intact skin of rabbits for 21–25 consecutive days. For comparison, two control groups were used in each study: one dosed with the appropriate vehicle and one nmfreated group.

The results of these studies have shown that erythema produced on intact rabbit skin by each of the medicated cream formulations was equivalent or slightly less than that produced by each of the corresponding vehicles. There was no significant difference between the medicated and vehicle creams in the time of onset of erythema or in the incidence of edema, atonia, papules, pustules, desquamation, wrinkling, fissuring, or skin thickness. These findings suggest that tolnaftate, hydrocortisone, clotrimazole, gen-tamicin, and betamethasone can be used in combination in topical preparations with no increase in the potential for dermal irritation.