Use of tapinarof for the treatment of atopic dermatitis
Topical compositions and methods for using topical compositions comprising tapinarof to treat mild to moderate atopic dermatitis or plaque psoriasis are described herein. Also described are clinical endpoints for treatment of subjects diagnosed with mild to moderate atopic dermatitis, wherein about 5% to about 35% of body surface area was affected, and Investigator Global Assessment (IGA) score was greater than or equal to 3. Also described are clinical endpoints for treatment of subjects diagnosed with chronic mild to moderate plaque psoriasis for greater than or equal to 6 months, wherein about 3% to about 20% of body surface area was affected, and Physician Global Assessment (PGA) score was greater than or equal to 2.
1 . A method for treating mild to severe atopic dermatitis in a subject that is 2 years of age or older comprising topically administering to the subject a topical composition containing about 1.0% tapinarof to affected areas of the subject once a day, wherein after topically administering the topical composition an Investigator Global Assessment (IGA) score of the subject is improved by 2 grades and achieves an itch/pruritus numeric rating scale (NRS) score improvement of greater than or equal to 4 from baseline within 4 weeks and wherein topically administering the topical composition results in systemic exposure of tapinarof that is below the limit of detection.
2 . The method of claim 1 , wherein the topical composition is an oil-in-water emulsion.
3 . The method of claim 2 , wherein the oil phase of the oil-in-water emulsion is comprised of medium chain triglycerides, propylene glycol, non-ionic emulsifying wax, diethylene glycol monoethyl ether, polyoxyl stearyl ether-2, polysorbate 80, polyoxyl stearyl ether-20, benzoic acid, and butylated hydroxytoluene.
4 . The method of claim 2 , wherein the water phase of the oil-in-water emulsion is comprised of sodium citrate, edetate disodium, citric acid monohydrate, and water.
5 . The method of claim 1 , wherein the subject is between the age of 2 and 18.
6 . The method of claim 1 , wherein the topically administering includes application to the affected area of the skin selected from the group consisting of body, arms, legs, back, chest, buttocks, neck, scalp, fingernails, toenails, and combinations thereof.
7 . The method of claim 1 , wherein the subject has been diagnosed with mild to severe atopic dermatitis having a percent body surface area (BSA) affected of about 3% to about 20%.
8 . The method of claim 1 , wherein the subject has been diagnosed with mild to severe atopic dermatitis having an Investigator Global Assessment (IGA) score of greater than or equal to 3.
9 . The method of claim 1 , further comprising, after topically administering the topical composition, an improvement of one or more symptom of mild to severe atopic dermatitis as measured according to an assessment selected from the group consisting of Investigator Global Assessment (IGA) score, daily Itch/Pruritus numeric rating scale, Eczema Area and Severity Index (EASI), total severity score, percent body surface area (BSA) affected, sleep quality, dry/rough skin, red/discolored skin, flaky skin, visual analogue scale (VAS) for sleep, visual analogue scale (VAS) for itch, and patient reported outcomes.
10 . The method of claim 9 , wherein the Eczema Area and Severity Index (EASI) is improved by greater than or equal to 50% or is improved by greater than or equal to 75%.
11 . The method of claim 9 , wherein the percent body surface area (BSA) affected is decreased to less than 20%.
12 . The method of claim 9 , wherein the sleep quality is improved as measured by the visual analogue scale (VAS) for sleep.
13 . The method of claim 9 , wherein the patient reported outcomes demonstrated that subject's impressions of symptom severity was improved, wherein the symptoms are selected from the group consisting of itchy skin, red/discolored skin, bleeding, weeping or oozing skin, cracked skin, scaly skin, flaky skin, dry or rough skin, painful skin, burning skin, and disturbed sleep.
14 . The method of claim 9 , wherein the one or more symptom is improved after about 2 weeks, about 4 weeks, or about 8 weeks of administering the topical composition.
15 . The method of claim 9 , wherein the improvement of one or more symptom continues for about 4 weeks after administration of the topical composition has ceased.
16 . The method of claim 1 , wherein the IGA score is improved after about 2 weeks, about 4 weeks, or about 8 weeks of administering the topical composition.
17 . The method of claim 1 , wherein the improvement in IGA score continues for about 4 weeks after administration of the topical composition has ceased.
18 . The method of claim 1 , further comprising after topically administering the topical composition an improvement of one or more symptom of mild to severe atopic dermatitis as measured according to an assessment selected from the group consisting of daily Itch/Pruritus numeric rating scale (NRS), total severity score (TSS), dry/rough skin, red/discolored skin, flaky skin, visual analogue scale (VAS) for sleep, visual analogue scale (VAS) for itch, patient reported outcomes, and combinations thereof.
19 . The method of claim 1 , further comprising after topically administering the topical composition an improvement of one or more subject-reported outcomes selected from the group consisting of Subject Impression of Severity and Change questionnaire, expanded Patient-Oriented Eczema Measure (POEM), Daily Sign and Symptom Severity Diary, and combinations thereof.
20 . The method of claim 1 , wherein administration of the topical composition exhibits no accumulation of tapinarof in plasma of the subject with repeat administration.