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

Summary Background Vitamin B12 is an effective scavenger of nitric oxide (NO). As the experimental application of a NO synthase inhibitor, Nω‐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 B12. Objectives The efficacy and tolerability of a new vitamin B12 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 B12‐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 B12 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