In a double-blind, randomized, group-comparative clinical trial, 31 patients with acne vulgaris received topical treatment for 6-8 weeks with a lotion containing either 0.05% retinoic acid or 0.1 % of the retinoic acid derivative Ro 11-1430. The side-effects erythema, desquamation and burning were significantly less frequent with Ro 11-1430 than with retinoic acid. The treatments appeared to be approximately equally effective in reducing the number of acne elements, but due to the limited number of patients studied, the trial was admittedly not sufficient to detect differences with regard to therapeutic efficacy.
During the winter of 1971/72, eleven dermatologists in private practice and the dermatological departments of the Finsen Institute and Marselisborg Hospital conducted a controlled clinical trial to investigate the effect of topically applied tretinoin in patients with acne vulgaris using a 0.02-percent cream, a 0.05-percent cream, and the cream base alone. The effect of the treatment was evaluated by counting the acne lesions, the number being arranged according to a score system. As regards the effect on comedones and papules, the tretinoin cream was significantly better than the cream base alone. A concentration of 0.05% showed a quicker onset of action and a more pronounced effect than a concentration of 0.02%. The effect of the treatment was less pronounced and not statistically significant as far as pustules and cysts were concerned. The investigation confirmed previous good experience with this form of treatment. The effect upon the placebo group was considerable. This calls for caution when the effect of new acne agents is to be evaluated. Attention is drawn to the special form of cooperation used in the investigation; in this way, it was possible to include a great number of out-patients.
The effect of a new non-steroid anti-inflammatory substance (bufexamac) in a special constituent was compared with that of 0.1% triamcinolone acetonide, 1% hydrocortisone cream, and placebo during a double-blind multicentre trial. The clinical effect of these four creams was studied in 193 patients receiving treatment for the following skin disorders: atopic dermatitis, allergic contact dermatitis, and non-allergic contact dermatitis, as well as dermatitis seborrheica. After 2 and 4 weeks’ treatment, when 193 and 157 patients, respectively, were re-examined, the effect of triamcinolone acetonide and hydrocortisone cream was significantly better, than that obtained with bufexamac in the cream basis employed. On the other hand, no statistically significant difference in effect between bufexamac and placebo cream was observed.
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