Azeco Cosmeceuticals

This includes beneficial bacteria that live with us in harmony. Long term use of these ingredients will result in premature skin ageing, semi-permanent skin dehydration and a complete disruption of the skin’s microflora. The ultimate result is an attack on the overall immune system with all consequences. Several of these frequently used anti-acne ingredients have outspoken CMR proper-ties (Carci- nogenicity-Mutagenicity-Reprotoxicity). The FDA have placed in January 2014 an inquiry for surveillance for adverse drug effects for anti-acne products containing benzoyl peroxide, salicylic acid, or both, on its latest quarterly list of products to monitor because of potential signals of hyper-sensitivity and anaphylactic reactions. Reference is made to:

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm376571.htm.

Azelaic acid is able to assist in normalisation of the microflora on the skin. Organisms that have become opportunistic are normalised to their normal level, including P.acnes, and it thus assists in many cases in clearing and preventing acne. Azelaic acid is prescribed mostly in cream form and works well in mild to moderate outbreaks of acne; it does not work for forms of acne that have a different origin. It takes 1-2 months before azelaic acid starts to show its performance and the acne lesions to start disappearing. The mode of action has not been fully elucidated, but in numerous preclinical and clinical studies it has been demonstrated that aze- laic acid displays three pharmacological properties: 1. It normalizes the disturbed follicular keratinization that leads to the formation of comedones in acne patients. The reduction in the count of comedones has subsequently been demonstrated in various clinical studies. 2. Azelaic acid has a significant antibacterial effect on the follicular Propionibacterium acnes and Staphylococcus epidermidis (in vitro). This effect is primarily bactericidal but may in vivo be modified to a bacteriostatic one. Studies have shown that in acne patients two or three months of topical treatment with azelaic acid reduces the intra-follicular microbial colonization by more than 97.7%. Whereas P.acnes is frequently resistant against topical antibiotics such as erythromycin and/or clindamycin, there are no indications that P.acnes may become resistant against azelaic acid. 3. In addition it has been shown that azelaic acid is effective in inhibiting the growth of antibiotic resistant P.acnes. 4. In addition to an indirect effect on inflammation by reducing the growth and activity of P.acnes, azelaic acid also reveals direct anti-inflammatory activities by reducing the production and release of reactive oxygen species from neutrophils. This direct anti-in - flammatory property is considered to be the basis for the clinical effect of azelaic acid in treating rosacea. Azelaic acid is not restricted in use in personal care and cosmetic products in the European Union. It shall nonetheless be emphasized that EU Legislation does not allow the claim “prevents” or “cures” acne vulgaris. A semantic approach is required to present anti-ac- ne products containing azelaic acid, such as “suppresses the occurrence of pimples” and similar statements.

Mussenberg 1 • 6049 GZ Roermond • The Netherlands

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