Topical vitamin B12 -: a new therapeutic approach in atopic dermatitis-evaluation of efficacy and tolerability in a randomized placebo-controlled multicentre clinical trial

Background Vitamin B-12 is an effective scavenger of nitric oxide (NO). As the experimental application of a NO synthase inhibitor, Nomega-nitro-L-arginine, led to a clear decrease in pruritus and erythema in atopic dermatitis, it would be reasonable to assume a comparable effect of vitamin B-12. Objectives The efficacy and tolerability of a new vitamin B-12 cream as a possible alternative to current therapies was examined. Methods A prospective, randomized and placebo-controlled phase III multicentre trial, involving 49 patients was conducted. For the treatment duration of 8 weeks, each patient applied twice daily (in the morning and evening) the vitamin B-12-containing active preparation to the affected skin areas of one side of the body and the placebo preparation to the contralateral side according to the randomization scheme. Results On the body side treated with the vitamin B-12 cream, the modified Six Area Six Sign Atopic Dermatitis score dropped to a significantly greater extent than on the placebo-treated body side (for the investigational drug 55.34 +/- 5.74 SEM, for placebo 28.87 +/- 4.86 SEM, P < 0.001). At the conclusion of the study, the investigator and patients awarded mostly a 'good' or 'very good' rating to the active drug (58% and 59%, respectively) and a 'moderate' or 'poor' rating to the placebo (89% and 87%, respectively). Conclusions Topical vitamin B-12 is a new therapeutic approach in atopic dermatitis. These results document a significant superiority of vitamin B-12 cream in comparison with placebo with regard to the reduction of the extent and severity of atopic dermatitis. Furthermore, the treatment was very well tolerated and involved only very low safety risks for the patients.