Systematic evaluation of topical dosage form type and approved indications for dermatologic use

Summary: Abstract Body: Suitability of the dosage form (e.g., gel, ointment, etc.) of a drug product for a given indication is important for optimal therapeutic effect and user compliance. We reviewed the current landscape of approved dosage form type and labeled indications for innovator dermatologic products in the United States as of 12/31/2024, to explore whether a trend exists between the dosage form and indication for these products. 360 dermatologic products were identified and comprise of 26 dosage forms and 25 (consolidated) indications. By count, the top five dosage forms are cream, gel, ointment, lotion and solution. The top ten indications are corticosteroid responsive dermatoses, acne, fungal infection, psoriasis, antiseptic use, actinic keratoses, rosacea, pain, atopic dermatitis and viral infection. Most dermatologic products for corticosteroid responsive dermatoses appear to be emulsion-based dosage forms (57%) or ointments (29%), which have emollient effects that may provide better barrier restoration. Antifungal, psoriasis, atopic dermatitis, and rosacea products follow a similar trend. In contrast, acne products appear to be mostly gels (51%) or dosage forms like solutions, swabs, and foam aerosols (18%), which may facilitate application and potentially be less comedogenic than emulsion-based dosage forms. Topical delivery systems (patches) are typically approved for local deep tissue or neuropathic pain. Antiseptic products are mostly solution-based dosage forms that may include a device to assist with the application. In addition, solutions, lotions, oils, foam aerosols, and shampoos are approved for products indicated for scalp use only, as they may offer a more homogenous distribution on the scalp. An obvious trend was not observed for products for actinic keratoses or viral infection. The prevalence of dosage form types approved for topical dermatologic products generally aligns with their indicated treatment needs, supporting the importance of making rational choices related to selection of the dosage form and excipients during development. Ying Jiang¹, Priyanka Ghosh¹, Markham C. Luke¹ 1. Office of Research and Standards, Office of Generic Drugs, CDER, U.S. FDA, Silver Spring, MD, United States. Epidermal Structure and Barrier Function