Product Information
Registration Status: ActiveSIN07138P
SKINOREN CREAM 20% is approved to be sold in Singapore with effective from 1992-07-14. It is marketed by LEO PHARMA ASIA PTE LTD, with the registration number of SIN07138P.
This product contains Azelaic Acid 20g/100g in the form of CREAM. It is approved for TOPICAL use.
This product is manufactured by Bayer HealthCare Manufacturing S.r.I. in ITALY.
It is a has been granted the exemption for supply without a presciption if it met certain criteria.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Azelaic acid is a saturated dicarboxylic acid found naturally in wheat, rye, and barley. It is a natural substance that is produced by Malassezia furfur (also known as Pityrosporum ovale), a yeast that lives on normal skin. It is effective against a number of skin conditions, such as mild to moderate acne, when applied topically in a cream formulation of 20%. It works in part by stopping the growth of skin bacteria that cause acne, and by keeping skin pores clear. Azelaic acid's antimicrobial action may be attributable to inhibition of microbial cellular protein synthesis.
Indication
For the topical treatment of mild-to-moderate inflammatory acne vulgaris.
Mechanism of Action
The exact mechanism of action of azelaic acid is not known. It is thought that azelaic acid manifests its antibacterial effects by inhibiting the synthesis of cellular protein in anaerobic and aerobic bacteria, especially Staphylococcus epidermidis and Propionibacterium acnes. In aerobic bacteria, azelaic acid reversibly inhibits several oxidoreductive enzymes including tyrosinase, mitochondrial enzymes of the respiratory chain, thioredoxin reductase, 5-alpha-reductase, and DNA polymerases. In anaerobic bacteria, azelaic acid impedes glycolysis. Along with these actions, azelaic acid also improves acne vulgaris by normalizing the keratin process and decreasing microcomedo formation. Azelaic acid may be effective against both inflamed and noninflamed lesions. Specifically, azelaic acid reduces the thickness of the stratum corneum, shrinks keratohyalin granules by reducing the amount and distribution of filaggrin (a component of keratohyalin) in epidermal layers, and lowers the number of keratohyalin granules.
Pharmacokinetics
- Absorption
- Approximately 4% of the topically applied azelaic acid is systemically absorbed.
- Distribution
- Metabolism
- Mainly excreted unchanged in the urine but undergoes some b-oxidation to shorter chain dicarboxylic acids.
- Elimination
Toxicity
Oral LD50 in rat: >5 g/kg
Active Ingredient/Synonyms
1,7-Dicarboxyheptane | 1,7-Heptanedicarboxylic acid | 1,9-Nonanedioic acid | Acide azélaïque | Ácido azelaico | Acidum acelaicum | Acidum azelaicum | Anchoic acid | Azelaic acid | Azelainsaeure | Azelainsäure | Lepargylic acid | N-Nonanedioic acid | Nonandisaeure | Nonandisäure | Nonanedioic acid | Skinoren | Azelaic Acid |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.