Abstract: Methods of treating one or more skin lesions using cantharidin as well as associated compositions, treatment regimens, kits, devices, and systems are provided. A method of treating a subject having one or more skin lesions may involve administering a composition comprising cantharidin to one or more skin lesions. The method may allow for the efficacious treatment of the skin lesion(s) with minimal or no adverse side effects (e.g., severe adverse side effects, permanent damage of the dermal tissue, scarring, excessive blistering of skin surrounding the lesion, elevated plasma cantharidin concentration, systemic exposure to cantharidin). The efficacy and/or safety of the treatment may be due, to certain features of the composition and/or prolonged exposure of the skin lesion(s) to cantharidin. The methods described herein may be used for a wide variety of cutaneous disorders, including skin disorders that primarily affect the epidermis of skin.

Abstract: Methods of treating one or more skin lesions using cantharidin as well as associated compositions, treatment regimens, kits, devices, and systems are provided. A method of treating a subject having one or more skin lesions may involve administering a composition comprising cantharidin to one or more skin lesions. The method may allow for the efficacious treatment of the skin lesion(s) with minimal or no adverse side effects (e.g., severe adverse side effects, permanent damage of the dermal tissue, scarring, excessive blistering of skin surrounding the lesion, elevated plasma cantharidin concentration, systemic exposure to cantharidin). The efficacy and/or safety of the treatment may be due, to certain features of the composition and/or prolonged exposure of the skin lesion(s) to cantharidin. The methods described herein may be used for a wide variety of cutaneous disorders, including skin disorders that primarily affect the epidermis of skin.

Abstract: A method for altering the PK profile of a pharmaceutical formulation containing a PDE-4 inhibitor, such as roflumilast, to reduce the spike in Cmax. The spike in Cmax is reduced by topically administering the PDE-4 inhibitor in combination with one or more phosphate ester surfactants. Reducing the spike in Cmax will reduce gastrointestinal side effects and result in better patient compliance.

Abstract: An improved a method of treating a patient having a disorder responsive to PDE-4 inhibition by administering roflumilast. The improvement involves administering the roflumilast topically in a composition having a roflumilast release profile that produces in the patient a flattened plasma concentration time curve and a reduced Cmax relative to oral administration of a PDE4-inhibiting amount of roflumilast. Such disorders include inflammatory disorders such as inflammatory dermatoses, including psoriasis, atopic dermatitis and seborrheic dermatitis. Such disorders also include inflammatory diseases in a variety of organs, especially the lungs (asthma, COPD). Because of reduced side effects with topical administration due to the improved pharmacokinetics (PK) characteristics, it may be possible to provide higher systemic exposures (AUCs) with topical administration, resulting in greater therapeutic efficacy than with the oral route of administration.

Abstract: Applicator devices (1), kits, systems, and methods of using such devices for treating one or more body surface conditions (e.g., warts, Molluscum contagiosum, conjunctivitis, otitis) are provided. The applicator device facilitates topical administration of a controllable amount of a pharmaceutical composition to a desired area of an affected body surface (e.g., skin, eye, ear, nose, mouth, anus, vagina). The applicator device includes an ampule (40) containing the pharmaceutical composition, the ampule being positioned within a tube (50). Squeezing the tube breaks the ampule, releasing the pharmaceutical composition. The applicator device includes a filter (30) that permits passage of fluid and inhibits passage of broken ampule shards. The applicator device includes a dispensing tip (20) through which the pharmaceutical composition passes.

Abstract: A method for altering the PK profile of a pharmaceutical formulation containing a PDE-4 inhibitor, such as roflumilast, to reduce the spike in Cmax. The spike in Cmax is reduced by topically administering the PDE-4 inhibitor in combination with one or more phosphate ester surfactants. Reducing the spike in Cmax will reduce gastrointestinal side effects and result in better patient compliance.

Abstract: Methods of treating one or more skin lesions using cantharidin as well as associated compositions, treatment regimens, kits, devices, and systems are provided. A method of treating a subject having one or more skin lesions may involve administering a composition comprising cantharidin to one or more skin lesions. The method may allow for the efficacious treatment of the skin lesion(s) with minimal or no adverse side effects (e.g., severe adverse side effects, permanent damage of the dermal tissue, scarring, excessive blistering of skin surrounding the lesion, elevated plasma cantharidin concentration, systemic exposure to cantharidin). The efficacy and/or safety of the treatment may be due, to certain features of the composition and/or prolonged exposure of the skin lesion(s) to cantharidin. The methods described herein may be used for a wide variety of cutaneous disorders, including skin disorders that primarily affect the epidermis of skin.