Abstract: The present invention, in some embodiments, relates to a method of treatment, prevention or alleviation of Palmoplantar Keratoderma (PPK) or Olmsted syndrome in a patient in need thereof, comprising a debridement step followed by topical administration of a composition comprising at least one Epidermal Growth Factor Receptor (EGFR) inhibitor.

Abstract: Provided herein is a topical combination composition comprising from about 0.25% w/w to about 2.0% w/w tapinarof, from about 0.025% w/w to about 0.1% w/w tazarotene and a carrier suitable for topical administration. Also provided is a topical combination composition comprising from about 0.25% w/w to about 2.0% w/w tapinarof, from about 0.025% w/w to about 0.1% w/w w tazarotene, from about 0.01% w/w to about 0.25% w/w at least one corticosteroid of potency class 1-4 and a carrier suitable for topical administration. The above compositions are useful for the treatment, prevention or alleviation of plaque psoriasis and exhibit synergistic and/or additive effects which allow reducing the amounts of the active agents in the compositions. The addition of tazarotene to tapinarof potentiates the tapinarof anti-psoriatic therapeutic effect.

Abstract: Provided herein are topical combination compositions comprising a therapeutically effective dose of tapinarof and a therapeutically effective dose of at least one additional active agent, selected from at least one corticosteroid, calcipotriene, at least one JAK inhibitor and combinations thereof, and a carrier suitable for topical administration. The above compositions are useful for the treatment, prevention or alleviation of skin disorders selected from psoriasis and atopic dermatitis and exhibit synergistic or additive effects which allow reducing the doses of the active agents in the compositions.

Abstract: The present invention, in some embodiments thereof, relates to a topical composition for use in treating, preventing, alleviating and/or ameliorating pruritus, wherein the composition comprises tapinarof and the pruritus is not associated with atopic dermatitis, psoriasis or any combination thereof.

Abstract: This invention relates to compositions and methods of treatment of skin or mucosal disorders by administration of compositions comprising at least one EGFR inhibitor, such as topical compositions comprising erlotinib. The compositions of this invention are useful for the treatment, prevention or amelioration of skin or mucosal disorders like psoriasis, palmoplantar psoriasis, acquired palmoplantar keratosis, eczema, ichtyosis vulgaris, non-melanoma skin cancer, actinic keratosis, a keratinization skin disorder, a keratinization mucosal disorder, pachyonychia congenita, hidradenitis suppurativa, Gorlin syndrome, prurigo nodularis and prurigo pigmentosa.

Abstract: Provided herein is a topical combination composition comprising roflumilast, roflumilast N-oxide or pharmaceutically acceptable salt thereof, and at least one additional active agent selected from a retinoid, benzoyl peroxide (BPO) and combinations thereof. The active agents in the composition of this invention are in encapsulated or non-encapsulated form, according to need. The above composition is useful for the treatment, prevention or alleviation of a skin disorder selected from acne and rosacea and exhibits synergistic and/or additive effects allowing to reduce the active agents amounts in the topical combination compositions.

Abstract: Provided herein is a topical composition comprising roflumilast, roflumilast N-oxide or salts thereof as an active agent. The active agent in the composition of this invention is in encapsulated or non-encapsulated form, according to need. The above composition is useful for the treatment, prevention or alleviation of a skin disorder selected from Hidradenitis suppurativa and Prurigo nodularis.

Abstract: The present invention relates to the treatment of an ocular inflammatory disease or an ocular degeneration disease by ophthalmic administration of a composition comprising tapinarof and optionally at least one additional active agent. The composition of the present invention is useful for the treatment, prevention and/or alleviation of the symptoms of an ocular inflammatory disease or an ocular degeneration disease selected from uveitis, vitritis, dry eye disease (DED), macular degeneration, idiopathic orbital inflammatory disease (IOD), chorioretinal inflammation, keratitis, age-related macular degeneration and combinations thereof.

Abstract: The present invention relates to the treatment of an ocular inflammatory disease or an ocular degeneration disease by ophthalmic administration of a composition comprising tapinarof and optionally at least one additional active agent. The composition of the present invention is useful for the treatment, prevention and/or alleviation of the symptoms of an ocular inflammatory disease or an ocular degeneration disease selected from uveitis, vitritis, dry eye disease (DED), macular degeneration, idiopathic orbital inflammatory disease (IOD), chorioretinal inflammation, keratitis, blepharitis, seborrheic dermatitis of eyelids, seborrheic dermatitis of eyebrows, hyperemia, thyroid eye disease (TED), age-related macular degeneration, orbital myositis, and combinations thereof.

Abstract: The present invention relates to the treatment of an ocular inflammatory disease or an ocular degeneration disease by ophthalmic administration of a composition comprising tapinarof and optionally at least one additional active agent. The composition of the present invention is useful for the treatment, prevention and/or alleviation of the symptoms of an ocular inflammatory disease or an ocular degeneration disease selected from uveitis, vitritis, dry eye disease (DED), macular degeneration, idiopathic orbital inflammatory disease (IOD), chorioretinal inflammation, keratitis, blepharitis, seborrheic dermatitis of eyelids, seborrheic dermatitis of eyebrows, hyperemia, thyroid eye disease (TED), age-related macular degeneration and combinations thereof.

Abstract: A first-line treatment regimen is described for the therapeutic treatment of rosacea. The regimen includes topically applying to the skin of a subject in need of said treatment a pharmaceutical composition, the pharmaceutical composition including from about 1% to about 10% benzoyl peroxide as the sole active ingredient, and a pharmaceutically acceptable carrier or excipient. The regimen achieves, in a group of such subjects, a primary measure of success of at least about 9%, the primary measure of success being defined as a 2-grade improvement in Investigator Global Assessment (IGA) of clear or almost clear, and a secondary measure of success of at least about 40%, the secondary measure of success being defined as a percentage decrease the in the number of inflammatory lesions, and said pharmaceutical composition is applied once daily for a period of at least about 2 weeks.

Abstract: This invention relates to compositions and methods of treatment of skin or mucosal disorders by administration of compositions comprising at least one EGFR inhibitor, such as topical compositions comprising erlotinib. The compositions of this invention are useful for the treatment, prevention or amelioration of skin or mucosal disorders like psoriasis, palmoplantar psoriasis, acquired palmoplantar keratosis, eczema, ichtyosis vulgaris, non-melanoma skin cancer, actinic keratosis, a keratinization skin disorder, a keratinization mucosal disorder, pachyonychia congenita, hidradenitis suppurativa, Gorlin syndrome, prurigo nodularis and prurigo pigmentosa.

Abstract: The present disclosure relates to methods of treatment of acne in a patient in need thereof, comprising the concomitant once daily topical administration of from about 2% w/w to about 10% w/w of solid particulate benzoyl peroxide (BPO) and from about 0.01% w/w to about 0.1% w/w of solid particulate all trans retinoic acid (ATRA) for a period of up to 3 months, wherein the side-effects of the two actives are medically acceptable and wherein the therapeutic effect of BPO and ATRA is superior to the effect of each active administered alone. The concomitant administration may be carried out by once daily administration to a patient in need thereof of a single composition or of a first composition comprising BPO and a second composition comprising ATRA from a dual chamber dispenser or from two separate dispensers, mixed before applying on the skin of a patient in need thereof for up to 2 weeks, up to 1 month, preferably up to 2 months and more preferably up to 3 months.

Abstract: The present disclosure relates to methods of treatment of acne in a patient in need thereof, comprising the concomitant once daily topical administration of from about 20 w/w to about 10% w/w of solid particulate benzoyl peroxide (BPO) and from about 0.01% w/w to about 0.1% w/w of solid particulate all trans retinoic acid (ATRA) for a period of up to 3 months, wherein the side-effects of the two actives are medically acceptable and wherein the therapeutic effect of BPO and ATRA is superior to the effect of each active administered alone. The concomitant administration may be carried out by once daily administration to a patient in need thereof of a single composition or of a first composition comprising BPO and a second composition comprising ATRA from a dual chamber dispenser or from two separate dispensers, mixed before applying on the skin of a patient in need thereof for up to 2 weeks, up to 1 month, preferably up to 2 months and more preferably up to 3 months.

Abstract: The invention provides an oral pharmaceutical composition comprising modafinil particles, wherein at least about 5% of said modafinil particles have a diameter greater than 200 microns.

Abstract: A method for treating a disease or disorder of the skin or scalp of a mammal while simultaneously cleansing the skin or scalp is disclosed. The method includes administering to the skin or scalp a mousse formed from a composition that includes a therapeutically or cosmeceutically effective amount of at least one active pharmaceutical ingredient, 10% to 50% by weight of a cleansing agent selected from the group consisting of anionic surfactants, nonionic surfactants and combinations thereof, a pharmaceutically acceptable mousse-forming carrier that includes a propellant, the propellant being 3% to 50% by weight of the composition, and water being about 40% to about 90% by weight of the composition, waiting a period of time; and rinsing said skin or scalp with water to remove the mousse.

Abstract: Provided is a topical cream composition for the delivery of mometasone furoate comprising low dose mometasone furoate for the treatment of corticosteroid responsive dermatoses. The composition of the present invention can be safely applied over large surface areas of the skin (including areas with wrinkles and/or hair), and can be used therapeutically for extended periods of time (e.g., greater than 3 weeks). Treatment with the composition of the present invention carries reduced and/or fewer side effects compared with commercially available mometasone furoate cream products. The cream composition of the present invention is safe for the use of babies and infants under 2 years old. Additionally provided are methods of preparing and using the composition of the invention.

Abstract: The invention provides an oral pharmaceutical composition comprising modafinil particles, wherein at least about 5% of said modafinil particles have a diameter greater than 200 microns.

Abstract: A method and a composition for the treatment of an Inflammatory Bowel Disease (IBD) or intestine polyposes is described. The method includes the local administration to the colon of a therapeutically effective amount of at least one Selective Serotonin Reuptake Inhibitor (SSRI) or at least one tricyclic antidepressant (TCA).

Abstract: Pharmaceutical, cosmetic and cosmeceutical compositions for topical application, containing, as active ingredients, urea and/or derivatives thereof and alpha-hydroxy acid and/or an ammonium salt thereof, such as ammonium lactate, processes of manufacturing same and use of same in the treatment of medical and cosmetic skin and scalp conditions.