JP-2022533113-A5 -

Dates

Publication Date

20230512

Application Date

20200512

Description

(Equal portions) Those skilled in the art will recognize many equivalents of the specific embodiments of the invention described herein, or can confirm them by mere experimental means. The scope of the invention is not intended to be limited to the above description, but is set forth in the following claims. The present invention includes the following aspects and embodiments. [1] A method for treating an object requiring treatment, comprising administering multiple doses of a composition that delivers a large drug having a molecular weight of 100,000 Da or more to a site on the skin of the object, in combination with microneedle skin conditioning (MSC), according to a dosing regimen in which at least two consecutive doses are separated from each other by a period of at least one month. [2] The method according to [1], wherein the period is at least two months. [3] The method according to [1], wherein the period is at least four months. [4] The method according to [1], wherein the period is at least 6 months. [5] The method according to [1], wherein the period is at least 8 months. [6] The method according to [1], wherein the period is at least 10 months. [7] The method according to [1], wherein the period is at least 12 months. [8] The method according to [1], wherein the administration regimen comprises administering at least three doses separated by at least first and second periods, the mean period being at least one month. [9] The method described in [8], wherein the average duration is at least two months. [10] The method described in [8], wherein the average duration is at least four months. [11] The method described in [8], wherein the average duration is at least 6 months. [12] The method described in [8], wherein the average duration is at least 8 months. [13] The method described in [8], wherein the average duration is at least 10 months. [14] The method described in [8], wherein the average duration is at least 12 months. [15] The method according to [8], wherein each period is the same. [16] The method according to [15], wherein each period is at least one month. [17] The method according to [15], wherein each period is at least two months. [18] The method according to [15], wherein each period is at least four months. [19] The method according to [15], wherein each period is at least six months. [20] The method according to [15], wherein each period is at least eight months. [21] The method according to [15], wherein each period is at least 10 months. [22] The method according to [15], wherein each period is at least 12 months. [23] The method according to any one of [1] to [22], wherein administration comprises applying the composition topically to a site. [24] The method according to any one of [1] to [23], wherein the composition comprises a nanoemulsion. [25] The method according to any one of [1] to [24], wherein the composition comprises a macroemulsion. [26] The method according to any one of [1] to [25], further comprising a step of administering a non-irritating osmotic agent. [27] The method according to [26], wherein a non-irritating penetration enhancer is selected from carrier peptides and copolymers. [28] The method according to any one of [26] to [27], wherein the non-irritating penetration enhancer is selected from a cationic peptide having the sequence RKKRRQRRRG-(K) 15 -GRKKRRQRRR and a positively charged carrier. [29] The method according to any one of [1] to [28], wherein the administration process includes performing MSC before administering the composition to the site. [30] The method according to any one of [1] to [29], wherein the administration process includes performing MSC after administration of the composition to the site. [31] The method according to any one of [1] to [30], wherein the administration process includes performing MSC simultaneously with the administration of the composition to the site. [32] The method according to any of [1] to [31], wherein the main drug is botulinum toxin. [33] The method according to [32], wherein the administration process is further combined with a cosmetic or therapeutic agent. [34] The method according to [33], wherein the cosmetic agent or therapeutic agent is selected from the group consisting of anesthetics, collagen, fillers, retinoids, silicones, steroids, and combinations thereof. [35] The method according to [34], wherein the cosmetic or therapeutic agent is selected from the group consisting of hydrocortisone, retin-A, lidocaine, and combinations thereof. [36] The method according to any of [1] to [35], wherein the lead drug is an antibody drug. [37] The method according to [36], wherein the antibody drug is selected from the group consisting of anti-TNFα antibody, anti-CD2 antibody, anti-CD4 antibody, anti-IL-12 antibody, anti-IL-17 antibody, anti-IL-22 antibody and anti-IL-23 antibody. [38] The method according to any one of [36] to [37], wherein the antibody drug is selected from the group consisting of antibodie