611 Address all correspondence to Francesca Pajuelo Lorenzo, francesca.pajuelo@almirall.com Efficacy, Tolerability, and Acceptability of a Skin Repair Product Containing Active Extracts of Centella asiatica ELENA GONZALEZ-GUERRA AND FRANCESCA PAJUELO LORENZO Department of Dermatology, Hospital Clínico San Carlos, Madrid, Spain (E.G.G.) Medical Affairs Department, Almirall, S.A., Barcelona, Spain (F.P.L.) Accepted for publication October 7, 2021. Synopsis The reparatory capacity of Centella asiatica based on collagen synthesis stimulation and accelerating reconstruction and renewal of the epidermis has been the focus of research in cosmetology. Here we present the efficacy and safety results of a product that has been developed, combining the properties of asiaticoside and asiatic acid contained in C asiatica, in the form of a light-textured and rapidly absorbing cream (Blastoactiva™) particularly indicated for the treatment of damaged skin with altered barrier function. Experimental and human studies have shown the beneficial anti-irritant effect, skin barrier function repair, and epidermal cell renewal enhancing action of the product, as well as great acceptability referred to its cosmetic characteristics, with no allergenic or phototoxic potential. The incidence of sensitive skin due to minimal trauma and irritation is high in women due to erosions of the mammary areoles and nipples during lactation and in female genital lichen sclerosus. In the sensitive skin syndrome, characterized by the presence of subjective symptoms (burning, itching, stinging, pruritus, and tingling sensations) without any clinical signs on the skin, the use of cosmetics that restore the barrier function and decrease the reactivity of sensitive skin is recommended. Repair of the skin after performing nonsurgical aesthetic processes is an example where the use of Blastoactiva™ would be especially indicated. INTRODUCTION Integrity of the skin barrier is crucial for the maintenance of skin structure and functions. Disruption of the skin barrier can be caused by both endogenous factors such as age, systemic diseases, or genetic conditions, and exogenous factors such as solar exposure, pollution, trauma, or different cosmetic procedures. Disruption of the barrier results in increased permeability and thinning of the horny layer (1). These alterations in turn favor the penetration of irritants and allergens (2) and are associated with poorer protection of the nerve endings as well as transepidermal water loss (1). The alteration of the skin barrier can be the cause of or aggravate some inflammatory diseases (i.e., atopic dermatitis, psoriasis, or genital lichen sclerosus), where in addition to the presence of skin atrophy, there may be erosions. Likewise, there are other physiological J. Cosmet. Sci., 72, 611–622 (November/December 2021)

612 JOURNAL OF COSMETIC SCIENCE circumstances such as breastfeeding, where between 80 to 90% of women have pain or fissures due to friction and suction, which compromises the barrier and may be the cause of the interruption of said feeding (3). These alterations not only represent an important alteration in the quality of life of patients but also imply the modification of the absorption of drugs or cosmetics, which makes the preservation of the cutaneous barrier of vital importance not only in healthy skin but also on diseased skin (4). Genital lichen sclerosus is a chronic, inflammatory disease that most frequently affects women of all ages (5), producing a great impact on quality of life and sexual health (6), and can progress to cancer. Erosions and itching may appear (7). It is recommended to avoid the use of irritating substances and perfumes (8). Persistent nipple pain is one of the most common causes of cessation of breastfeeding (9). The sensitive skin syndrome is characterized by the presence of subjective symptoms (burning, itching, stinging, pruritus, and tingling sensations) without any clinical signs on the skin. Sensitive skin is a broad term applied to hypersensitive, reactive, intolerant, or hyperexcitable skin, and used to define some characteristics of the skin rather than a medical diagnosis. Sensitive skin is associated with different dermal conditions and precipitating factors, and the underlying pathophysiological mechanisms are not fully understood (10,11). The use of cosmetics that restore the barrier function and decrease the reactivity is recommended (1). Centella asiatica extract is a rich source of natural bioactive substances, particularly triterpenoid saponins known as centelloids (12). The main compounds are the triterpenes asiatic acid and madecassic acid, and their derived triterpene (i.e., ester glycosides, asiaticoside, and madecassoside) (13,14). The triterpenic genin and asiaticoside contents of the purified extract have been shown to offer specific dermatological benefits related to skin healing and regeneration, increasing collagen synthesis and intracellular fibronectin, promoting fibroblast formation, stimulating hyaluronic acid synthesis, and improving cutaneous connective tissue regeneration (14–17). Asiaticoside is the fundamental active substance of C asiatica (18), and is responsible for most of its antioxidant, anti-inflammatory, immune modulating, and tissue repair properties (19,20). Asiatic acid in turn intervenes in molecular mechanisms related to enzymatic processes, growth factors, transcription factors, apoptotic proteins, and cell signaling pathways (21). Studies based on in vitro and in vivo models have found asiatic acid to prevent skin aging caused by ultraviolet radiation, suppress the accumulation of collagen produced by fibroblasts in the context of keloid scar formation, and favor wound epithelization (21). As a result of all this, formulations based on C asiatica extracts have been widely used over the years for different indicators, including improved healing of minor wounds and burns, hypertrophic scars, pregnancy stretch marks, and psoriatic or scleroderma lesions (22–24), and as antiaging products (25,26). Cosmetological research has evidenced the great reparatory capacity of C asiatica extracts, thanks to the stimulation of collagen synthesis, accelerating reconstruction, and renewal of the epidermis (27). In this regard, a product has been developed, combining the properties of asiaticoside and asiatic acid contained in C asiatica, in the form of a light-textured and rapidly absorbing cream (Blastoactiva™, Almirall, S.A., Barcelona, Spain), with different indications. Although this is a marketed and dermatologically tested product particularly indicated for the treatment of damaged skin with altered barrier function for adults, children, and babies 3 mo and older, no synthesis of the scientific evidence on its efficacy, tolerability, and acceptability under normal conditions of daily use has been published to date. The present