Topical vitamin B12—a new therapeutic approach in atopic dermatitis—evaluation of efficacy and tolerability in a randomized placebo-controlled multicentre clinical trial
Article first published online: 30 APR 2004
British Journal of Dermatology
Volume 150, Issue 5, pages 977–983, May 2004
How to Cite
Stücker, M., Pieck, C., Stoerb, C., Niedner, R., Hartung, J. and Altmeyer, P. (2004), Topical vitamin B12—a new therapeutic approach in atopic dermatitis—evaluation of efficacy and tolerability in a randomized placebo-controlled multicentre clinical trial. British Journal of Dermatology, 150: 977–983. doi: 10.1111/j.1365-2133.2004.05866.x
- Issue published online: 17 MAY 2004
- Article first published online: 30 APR 2004
- Accepted for publication 30 August 2003
- atopic dermatitis;
- inducible nitric oxide synthase;
- nitric oxide;
- vitamin B12
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 < 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 B12 is a new therapeutic approach in atopic dermatitis. These results document a significant superiority of vitamin B12 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.