INTRODUCTION
Acne vulgaris is a condition that affects up to 87% of adolescents and over 50% of adults.1 Acne sufferers commonly self-treat with well-established over the counter (OTC) products approved by the FDA under the OTC monograph. As a multi-factorial disease, acne is characterized by abnormal follicular keratinocyte desquamation, anaerobic Propionibacterium acnes proliferation, inflammation, and excess sebum production.2
Acne affects all races and ethnicities and is one of the most commonly diagnosed dermatological conditions. The prevalence of acne for women of childbearing age (19 to 45 years) is 32.5%, indicating potential for women who are pregnant to seek treatment.3 Until 2016, there were five non-prescription active ingredients available on the market: benzoyl peroxide (BPO), salicylic acid, sulfur, resorcinol and resorcinol monoacetate. Topical retinoids have long been considered first line therapy for the treatment of acne.4 The paradox is that some retinoids have a black box warning stating that women who are pregnant should not use these vitamin A receptor agonists.5
Excess systemic retinoid exposure during pregnancy can disrupt normal embryonic development in a wide range of experimental animals, targeting cardiovascular, CNS (central nervous system), craniofacial and skeletal development.6 In humans, administration of systemic therapeutic retinoids has been associated with developmental abnormalities including CNS (hydrocephalus, hypoplastic or malformed cerebellar or cerebral cortices), craniofacial region (cleft palate, external ear defects), heart, thymus and limbs.6 These abnormalities are associated specifically with oral retinoids. Although systemic exposure to topical retinoids is lower, the risk during pregnancy is inadequately studied.
Adapalene 0.1% Gel was originally approved as a prescription medication for the treatment of acne vulgaris in the United States in May 1996 (NDA 20380). Topical adapalene-containing products, formulated at various strengths between 0.1% and 0.3%, and in combination with BPO, were all approved Pregnancy Category C drugs before the FDA removed pregnancy categories from prescription medications.7 This
Acne affects all races and ethnicities and is one of the most commonly diagnosed dermatological conditions. The prevalence of acne for women of childbearing age (19 to 45 years) is 32.5%, indicating potential for women who are pregnant to seek treatment.3 Until 2016, there were five non-prescription active ingredients available on the market: benzoyl peroxide (BPO), salicylic acid, sulfur, resorcinol and resorcinol monoacetate. Topical retinoids have long been considered first line therapy for the treatment of acne.4 The paradox is that some retinoids have a black box warning stating that women who are pregnant should not use these vitamin A receptor agonists.5
Excess systemic retinoid exposure during pregnancy can disrupt normal embryonic development in a wide range of experimental animals, targeting cardiovascular, CNS (central nervous system), craniofacial and skeletal development.6 In humans, administration of systemic therapeutic retinoids has been associated with developmental abnormalities including CNS (hydrocephalus, hypoplastic or malformed cerebellar or cerebral cortices), craniofacial region (cleft palate, external ear defects), heart, thymus and limbs.6 These abnormalities are associated specifically with oral retinoids. Although systemic exposure to topical retinoids is lower, the risk during pregnancy is inadequately studied.
Adapalene 0.1% Gel was originally approved as a prescription medication for the treatment of acne vulgaris in the United States in May 1996 (NDA 20380). Topical adapalene-containing products, formulated at various strengths between 0.1% and 0.3%, and in combination with BPO, were all approved Pregnancy Category C drugs before the FDA removed pregnancy categories from prescription medications.7 This
