Abstract

1. Multicentric clinical trials on triamcinolone acetonide cream with new formulation were conducted at eleven medical institutions to assess its clinical efficacy in comparison to the old cream. The new cream formulation has several distinct features, e.g., (a) benzyl alcohol as a preservative instead of parabens, (b) increased water content, (c) new type emulsifier. In order to asertain the clinical efficacy of the new cream formulation the limited double-blind method was adopted. 2. In these clinical trials, a total of 129 patients were tested and analyzed ; 43 patients with the exudative type of eczematous dermatitis, 42 patients with the lichenified type of ec-zematous dermatitis and 44 patients with psoriasis vulgaris. 3. Analyses in the 95% significance level (p≤0.05) indicated no significant difference between the new and the old cream formulations in all types of dermatitis involved. However, it was suggested that the new cream formulation was clinically more effective than the old cream formulation particulary in psoriasis vulgaris and the exudative type of eczematous dermatitis from the results of drug preference. 4. The questionaire conducted with regard to the property of the new cream formulation in clinical use indicated that the new cream formulation was superior to the old cream in its' extension, refreshing feeling and vanishing on the lesion. 5. The study showed that triamcinolone acetonide new cream formulation is more useful than the old one.

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