Azelaic acid is a naturally occurring dicarboxylic acid found in grains like wheat, barley, and rye, commonly used in dermatology to manage various skin concerns. It functions as a mild exfoliant with anti-inflammatory and antimicrobial properties. During pregnancy, concerns often arise about the safety of topical medications, especially when managing hormonal skin changes. Azelaic acid is frequently recommended as a substitute for ingredients contraindicated during gestation. This article addresses the specific question of what concentration of azelaic acid is considered safe for use while pregnant.
Regulatory Classification and Systemic Absorption
Azelaic acid is considered a low-risk option for pregnant individuals due to its limited entry into the bloodstream after topical application. Only about three to four percent of the active ingredient is absorbed systemically when applied to the skin. This minimal absorption substantially reduces the possibility of fetal exposure.
The previous regulatory framework assigned azelaic acid to the former FDA Pregnancy Category B. This designation was used for medications where animal studies showed no fetal risk, but adequate human studies were lacking. Although the FDA has phased out this letter-categorization system, the Category B status historically reflected its favorable safety profile.
This profile contrasts with alternatives like retinoids, which are generally avoided during pregnancy due to known teratogenic risks when taken orally. Azelaic acid acts locally on the skin surface, making it a preferred choice for managing conditions without significant systemic risk.
Safe Use Concentrations During Pregnancy
Dermatological consensus supports the use of azelaic acid at all available concentrations during pregnancy, based on its low systemic absorption rate. Over-the-counter (OTC) products are typically available up to 10%, while prescription-strength formulations are available at 15% and 20% concentrations for more severe conditions.
The safety of higher prescription concentrations, such as 15% gel or 20% cream, is supported because systemic absorption remains low even at these strengths. Studies show that plasma concentrations of azelaic acid in users of the 15% gel are comparable to those using a vehicle-only product. This indicates that topical application does not significantly elevate the body’s natural levels of the acid.
Therefore, the specific percentage is less concerning than the overall low absorption profile, which is consistent across the therapeutic ranges of 10% to 20%. Consulting a healthcare provider is important to determine the most appropriate concentration and formulation for an individual’s specific condition and to balance effectiveness with safety throughout gestation.
Primary Skin Conditions Treated
Azelaic acid is a primary treatment for several skin issues that commonly arise or worsen during pregnancy.
Pregnancy-Induced Acne
One frequent concern is pregnancy-induced acne, which results from hormonal fluctuations that increase sebum production and inflammation. Azelaic acid’s antimicrobial action against acne-causing bacteria and its anti-inflammatory effects make it an effective and safe choice for clearing breakouts.
Melasma
Azelaic acid is also frequently recommended for melasma, often called the “mask of pregnancy,” characterized by dark, patchy hyperpigmentation on the face. This condition is triggered by hormonal changes and sun exposure. Azelaic acid manages melasma by inhibiting tyrosinase, an enzyme necessary for melanin production.
Because other effective treatments for hyperpigmentation, such as hydroquinone, are often avoided due to concerns about higher systemic absorption, azelaic acid provides a safe alternative. Its dual action in treating both acne and hyperpigmentation makes it a versatile component of a pregnancy-safe skincare routine, often replacing restricted ingredients like topical retinoids.