Pharmaceutical Form of Topical Corticosteroid(s) and Colloidal Oat With a Device for Precise Dosing

Introduction

Atopic dermatitis is the most common chronic inflammatory skin disease, which affects 10%-30% of children and 2%-10% of adults in developed countries (Kolb L, Ferrer-Bruke, 2023). Topical corticoids are commonly used to treat dermatologic diseases, such as atopic eczema, localized vitiligo, psoriasis, chronic hand eczema, localized bullous pemphigoid, phimosis, acute radiation dermatitis, lichen planus, lichen simplex chronicus, discoid lupus erythematosus, or lichen sclerosis, due to their known anti-inflammatory proprieties (Costa, Machado, Selores, 2005; Das, Panda, 2017; Garbos, Nessel, Zito, 2023; Mehta et al., 2016; WHO, 2023). The pharmacodynamic properties of corticosteroids are, as follows: anti-inflammatory (e.g., reduction of edema), vasoconstrictor (e.g., minimization of erythema), anti-proliferative (e.g., control of keloid formation), immunosuppressive (e.g., pathologies with increased of inflammatory mediators), tachyphylaxis (e.g., possibility of treatment resistance) or mineral and glucocorticoid (e.g., decrease in plasma cortisol, if applied in periods lived for long periods), among others (Costa, Machado, Selores, 2005; Goa, 1988).

Corticoids can be classified into four categories according to World Health Organization 2023 Anatomical Therapeutic Chemical (ATC) classification, depending on their potency of action (D07AA Corticosteroids, weak (group I); D07AB Corticosteroids, moderately potent (group II); D07AC Corticosteroids, potent (group III); and D07AD Corticosteroids, very potent (group IV)) (WHO, 2023). Next are presented some examples of topical corticoids by category (i to iv): (i) Hydrocortisone (class I – weak/low potency); Clobetasone Butyrate, Hydrocortisone Butyrate, Hydrocortisone Propionate Butyrate, Desonide, Alclometasone Dipropionate or Dexamethasone Valerate (class II – moderately potent); Fluocinolone Acetonide; Betamethasone Dipropionate; Betamethasone Valerate (class III – potent) or Halometasone or Clobetasol Propionate (class IV – very potent). New generation corticoids were more recently developed, such as: methylprednisolone aceponate, mometasone furoate or fluticasone propionate. However, the potency of topical corticosteroids can also be classified in 7 categories, for instance depending on the vehicle type. These 7 categories are, as follows: Class I superpotent corticosteroids (e.g., clobetasol propionate 0.05% in any vehicle or augmented betamethasone dipropionate 0.05% gel or ointment); Class II high-potency corticosteroids (e.g., amcinonide 0.1% ointment or augmented betamethasone dipropionate 0.05% cream or lotion); Class III medium- to high-potency corticosteroids (e.g., amcinonide 0.1% cream or betamethasone dipropionate 0.05% cream); Class IV and V medium-potency corticosteroids (e.g., betamethasone valerate 0.1% cream or lotion or foam or desoximetasone 0.05% cream); Class VI low-potency corticosteroids (e.g., alclometasone dipropionate 0.05% cream or ointment, desonide 0.05% in any vehicle) and Class VII least-potent corticosteroids (e.g., hydrocortisone 1% or 2.5% cream or lotion or ointment) (Ference, 2009; Gabros, Nessel, Zito, 2023).