Hydroxy B12 0.07% Zinc Pyrithione 0.25% Topical Cream
Topical B12 (hydroxycobalamin) and zinc pyrithione offers a non-steroidal approach to the pathogenesis of eczema.
Hydroxycobalamin/Zinc Pyrithione is commonly compounded as a 0.07/0.25% topical cream.
Although the pathyphysiology in not completely understood, there are numerous studies that implicate immune dysregulation and skin barrier dysfunction in atopic dermatitis (AD). An impaired skin barrier may be the initial step in the development of the atopic march as well as AD, which leads to further skin inflammation and allergic sensitization. Type 2 cytokines (IL-4, IL-5, IL-9, IL-13) as well as IL- 17 and IL-22 also contribute to skin barrier dysfunction and the development of AD. These proinflammatory cytokines are likely involved in the up-regulation of inducible Nitric Oxide Synthase (iNOS).
Nictric Oxide Synthase (NOS) is nearly ubiquitous amongst skn cell populations of the body, and includes keratinocytes, endothelial cells, fibroblasts, melanocytes adipocytes, Langerhans cells, neutrophils and macroohages. This broad distribution allows the production of NO which aids in formation of cutaneous protective barriers, antimicrobial defense, and circualtion regulation.
There are 2 isoforms which are conservatively expressed: NOS1/neruonal NOS (nNOS) and NOS3/endothelial NOS (eNOS) and produce small anounts of NO over short periods of time through calcium-depoendent enzymes regulated by calmodulin. The third isoform, NOS2/inducable (iNOS), however, generates large quantities of NO through a noncalcium dependent mechanism, and is stimulated by bacterial products, cytokines, and neuropeptides.1,2
NO can play both beneficial as well as harmful roles in skin health, and given NO’s important role in daily skin maintenance, NO imbalances caused by proinflammatory mediatiors leads to dysregualtion and disease.
Research conducted by Taniuchi3 and Necmettin4 confirms the correlation between an increased concentration of nitric oxide (NO) and the severity of the AD disease.
Therefore, targeted therapies could act to restore NO homeostasis, thereby alleviating the symptoms of these oftentimes debilitating conditions.
Cobinamide, a cobalamin (vitamin B12) precursor binds to NO with high affinity and has been shown to be a potent NO-scavenger in biologic systems.
To avoid the possible concentration-related adverse events, transdermal application considered the most appropriate way of administration.
Zinc inhibits the expression of integrins by keratinocytes and modulates the production of TNF-α and IL-6 and reduces the production of inflammatory mediators like nitric oxide. It is also proposed that it is the toll-like receptor mediated regulation of zinc homeostasis which influences dendritic cell function and immune processes.10
A prospective, randomized and placebo-controlled phase III multicenter trial involving 49 patients was conducted for 8 weeks. Each patient applied the cream twice daily (morning and evening) to the affected areas. On the side treated with 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 the placebo 28.87 +/- 4.86 SEM, P<0.001. Trial investigators and participants awarded ‘good’ or ‘very good’ ratings to the active drug (58% and 59%) versus moderate or poor rating to the placebo (89% and 87%, respectively.5
A 4 week double-blinded, randomized, placebo-controlled study with intraindividual left/right comparison was set up to determine whether topical vitamin B-12 would be effective in 21 patients ranging from 6 months to 18 year.
Skin treated with topical vitamin B12 improved significantly more than placebo treated skin at 2 and 4 weeks (p=0.02, 0.01 respectively)6
Another study evaluated the efficacy and tolerability of topical Vitamin B12-barrier cream (MB12) compared with standard glycerol-petrolatum-based emollient cream (GPC) used three times a day for mild AD. The study was conducted as a on one hemi-body randomized, controlled, single-blind, intra-patient left-to-right comparative trial by patients with clinical diagnosis of mild AD measured with total SCORAD index over 4 months. MB12 was compared on one hemi-body treated (GPC). All 22 patients were randomized (left or right side treated with MB12 or GPC). At week 12 a reduction from baseline in SCORAD index was assessed in both body sites with 77.6% SCORAD index reduction in the MB12 treated body sites versus 33.5% in the GPC treated body sites. These results suggest that MB12 could represent a new option in the treatment of mild AD.7
The topical use of B12 0.07%5,6,7 has been clinically studied for the use in atopic dermatitis in adults and children.
Pyrithione zinc, which is also known as zinc pyrithione, is a common ingredient in anti-dandruff shampoos, but it can also be effective at treating psoriasis, eczema, and acne. This is because of its antimicrobial, antibacterial, and antifungal properties.12
Apply Hydroxy-B12/Zinc Pyrithione 0.07/0.25% topical cream to affected areas twice daily.
Methylcobalamin
- Mild transient diarrhea
- Polycythemia
- Itching
- Transitory exanthema
- Edema
A mild exacerbation of the skin inflammation may be a common initial response (2-4 days after treatment initiation) with a subsequent consistent improvement of the disease state thereafter.
Vitamin B12/Zinc Pyrithione 0.07/0.25% cream is likely safe in children, pregnancy & lactation.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
- Han G, Zippin JH, Friedman A. From bench to bedside: the therapeutic potential of nitric oxide in dermatology. J. Drugs Dermatol. 2009;8(6):586–594.
- Kutner AJ, Friedman AJ. Use of nitric oxide nanoparticulate platform for the treatment of skin and soft tissue infections. Wiley Interdiscip. Rev. Nanomed. Nanobiotechnol. 2013;5(5):502–514.
- Taniuchi, S., Kojima, T., Hara Mt, K., Yamamoto, A., Sasai, M., Takahashi, H. and Kobayashi, Y. (2001), Increased serum nitrate levels in infants with atopic dermatitis. Allergy, 56: 693-695.
- Necmettin Akdeniz, Akin Aktaş, Teoman Erdem, Mehmet Akyüz & Şevki Özdemir (2004) Nitric oxide levels in atopic dermatitis, The Pain Clinic, 16:4, 401-405
- Stainer R, et al. Topical Vitamin B12 – a new therapeutic approach in atopic dermatitis – evaluation of efficacy and tolerability in a randomized placebo-controlled multicenter clinical trial. Br J Dermatol. 2004 May;150(5):977-83.
- Januchowski R. Evaluation of topical vitamin B(12) for the treatment of childhood eczema. J altern Complement Med. 2009 Apr;15(4):387-9
- S. P. Nistico, E. Del Duca, F. Tamburi et al., “Superiority of a vitamin B12-barrier cream compared with standard glycerol-petrolatum-based emollient cream in the treatment of atopic dermatitis: a randomized, left-to-right comparative trial,” Dermatologic Therapy, vol. 30, Article ID e12523, p. 5, 2017.
- Hibbs JB, Taintor RR, Vavrin Z, Rachlin EM. Nitric oxide: a cytotoxic activated macrophage effector molecule. Biochem Biophys Res Commun. 1988;157:87–94
- Xie QW, Kashiwabara Y, Nathan C. Role of transcription factor NF-κB/Rel in induction of nitric oxide synthase. J Biol Chem. 1994;269:4705–4708.
- Kitamura H, Morikawa H, Kamon H, et al. Toll-like receptor-mediated regulation of zinc homeostasis influences dendritic cell function. Nature Immunology. 2006;7(9):971–977
- Sadeghian G, Ziaei H, Nilforoushzadeh MA. Treatment of localized psoriasis with a topical formulation of zinc pyrithione. Acta Dermatovenerologica Alpina, Pannonica et Adriatica. 2011;20(4):187–190.
- Opdyke DL, Burnett CM, Brauer EW. Anti-seborrhoeic qualities of zinc pyrithione in a cream vehicle: II. Safety evaluation. Food Cosmet Toxicol. 1967;5(3):321–326
This drug monograph does not provide medical or legal advice. All content found on this drug monograph, including: text, images, audio, or other formats were created for informational purposes only. Viewing this drug monograph, receipt of information contained in this monograph, or the transmission of this information from our pharmacy does not constitute a pharmacist-patient relationship.
The medical information on this monograph is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay seeking it because of something you have read on this drug monograph.
If you think you may have a medical emergency, call your doctor, go to the emergency department, or call 911 immediately. Harbor Compounding Pharmacy does not recommend or endorse any specific tests, physicians, products, procedures, opinions, or other information that may be mentioned on any of our content.
Medical information changes constantly. Therefore the information on our drug monograph(s) should not be considered current, complete or exhaustive, nor should you rely on such information to recommend a course of treatment for you or any other individual. Reliance on any information provided by Harbor Compounding Pharmacy, its employees, contracted writers, or medical professionals presenting content for publication to Harbor Compounding Pharmacy is solely at your own risk.
Harbor Compounding Pharmacy
2000 Harbor Blvd, Suite C100
Costa Mesa, CA 92627