Broad-spectrum sunscreens containing the TriAsorB™ filter: In vitro photoprotection and clinical evaluation of blue light-induced skin pigmentation.

BACKGROUND: Blue light (BL), particularly high-energy visible (HEV) light (400-450 nm), can cause skin damage and pigmentation. Therefore, effective sunscreens should offer photoprotection beyond ultraviolet (UV) radiation to also prevent or limit BL-induced cutaneous effects. OBJECTIVES: To evaluate the in vitro BL photostability and photoprotection properties of nine sunscreens containing the broad-spectrum UV/BL phenylene bis-diphenyltriazine (PBDT or TriAsorB™) filter, together with three other organic UV filters, and to assess the in vivo photoprotection level provided by two of these products against BL-induced skin pigmentation. METHODS: In vitro BL photostability and photoprotection factors, comprising the percentage of BL radiation stopped by the product (%BL) and the critical wavelength extended to BL (BL-CW), were determined by spectrophotometry. The in vivo photoprotection provided by two representative sunscreens (i.e. similar formulations, one non-tinted and one tinted) was assessed in two open randomized studies (20 and 16 women, respectively) after exposure of two test areas (with and without sunscreen) on the back of each subject to a 412-nm irradiation dose at 50 J/cm2 , using instrumental and clinical measurements of skin pigmentation. The percentage sunscreen photoprotective effectiveness (%PPE) was calculated by comparing intrasubject post-exposure pigmentation changes between the with and without sunscreen test areas. RESULTS: In vitro, the nine PBDT-containing products were highly photostable and had a BL-CW ≥385 nm and a %BL ≥30% (range: 30%-50%), thus allowing effective BL photoprotection. In vivo, both representative sunscreens prevented BL-induced immediate skin pigmentation (1 and 24 h post-exposure) with %PPE values ranging from 50.7% to 75.5% for colorimetric assessments (p < 0.001) and from 31.2% to 72.7% for visual scores (p ≤ 0.001). CONCLUSIONS: All PBDT-containing sunscreens were considered effective at absorbing BL radiation in vitro. The two representative broad-spectrum sunscreens tested in subjects significantly reduced BL-induced immediate skin pigmentation following single exposure to monochromatic BL radiation.

Change in Cutibacterium acnes phylotype abundance and improvement of clinical parameters using a new dermocosmetic product containing Myrtus communis and Celastrol enriched plant cell culture extracts in patients with acne vulgaris.

BACKGROUND: Acne is a multifactorial chronic inflammatory disease of the pilosebaceous unit, where Cutibacterium acnes plays a main role. Recent papers demonstrated that specific C. acnes phylotypes were correlated with the severity of inflammatory acne and reported a specific loss of C. acnes phylotype diversity in this context. OBJECTIVES: The aim of this exploratory study was to evaluate the efficacy of a new dermocosmetic product containing Myrtus communis and Celastrol-enriched plant cell culture extracts on C. acnes phylotype abundance and clinical parameters in subjects with mild to moderate acne vulgaris. METHODS: Cutibacterium acnes phylotype diversity was evaluated by single-locus sequence typing sequencing on the nonlesional areas of the forehead, that is, areas excluding inflammatory lesions (papules and pustules) on day 1 (D1) and after 56 days (D57) of twice daily application of the dermocosmetic product on the whole face. Clinical efficacy on acne was also assessed by acne lesion counting and Global Evaluation Acne (GEA) score on D1 and D57. RESULTS: Our study confirmed the link between the presence of some C. acnes phylotypes and acne severity. The dermocosmetic cream was linked to a positive impact on C. acnes phylotypes: a significant decrease in pro-pathogen phylotype IC and increase in nonpathogen phylotype IB were observed in the nonlesional areas of acne on D57 compared to D1. In parallel, the clinical results showed a significant decrease in inflammatory and comedonal acne lesions and a significant improvement in the acne severity according to the GEA score. CONCLUSIONS: This study showed that the application of a new dermocosmetic product containing M. communis and Celastrol-enriched plant cell culture extracts was linked to a change in the C. acnes phylotype abundance and an improvement in acne severity.

Surveillance of dermo-cosmetic products: a global cosmetovigilance system to optimise product development and consumer safety.

In the absence of formal marketing authorisation, the manufacturers of cosmetic products are responsible for their compliance with the cosmetic regulations. To present the key features of a structured, reactive, and rigorous global cosmetovigilance system through practical examples. During clinical development, adverse reactions are collected formally and analysed by cosmetovigilance experts. After commercialisation, information on reported adverse reactions is sought directly from the consumers. The results of allergological investigations are systematically requested. Pre- and post-marketing cases are analysed along with other sources of information (e.g. monitoring of the literature) to detect safety signals per product and per ingredient. A cosmetovigilance index (CVI) is calculated for each formula, based on the number of cases, causality level and number of commercialised units. Updated periodically, it is used to detect signals and select the best tolerated formulas to help formulating new products. Examples of safety issues raised during development or after commercialisation, and corresponding corrective actions, are presented. These actions include (but are not limited to) a safety watch to closely monitor adverse reactions, the modification of the formula or a change in the packaging. Cosmetovigilance data also impact future product development, as illustrated by the work done on sunscreens. Through the rigorous collection and analysis of adverse reactions during development and after commercialisation, the safety of dermo-cosmetic products can be improved by taking the appropriate corrective actions, monitoring their effectiveness and optimising future product development by focusing on the best tolerated formulas.

A high-emollient liquid cleanser for very dry and atopic-prone skin: Results of an in-use tolerance and efficacy study conducted under dermatological, pediatric, and ophthalmological supervision.

BACKGROUND: Emollients play a key role in the treatment of eczematous lesions and xerosis such as in atopic dermatitis. However, studies that show the actual benefits of cleansers are few and far between. AIMS: This study aims to evaluate the tolerance and efficacy of a high-emollient liquid cleanser (HELC) designed for very dry and atopic-prone skin, in the absence of any additional skin care. The product is a soap-free and fragrance-free liquid cleanser, containing mild surfactants and a ternary system of selected emollients: glycerin, vaseline, and paraffin. METHODS: In-use study was conducted under dermatological, pediatric, and ophthalmological supervision in 50 subjects (infants, children, and adults) with "dry to very dry and atopic-prone" skin. The primary objective of this monocentric, open, and intra-individual study was to assess the dermatological and ophthalmological tolerance of HELC after 21 days of using it at least once a day on the face and body. The secondary objectives were to evaluate its efficacy based on a clinical score (SCORAD), assess its short- and long-term moisturizing effect by measuring hydration rates (Corneometer® ), and ascertain its cosmetic acceptability through a subjective evaluation questionnaire. RESULTS: The study validates the good dermatological and ophthalmological tolerance of HELC. Its efficacy was demonstrated by improvements in the SCORAD and moisturizing scores. Furthermore, the product was very well accepted by the subjects. CONCLUSION: The fragrance-free HELC tested in this study for 21 days on "dry to very dry and atopic-prone skin" improves skin dryness and pruritus while ensuring good tolerance.

In situ antioxidant activity of a dermo-cosmetic product: A randomized controlled clinical study.

Ultraviolet light enhances the generation of reactive oxygen species that are responsible for skin photoageing. The aim of this randomized, vehicle- and active-controlled double-blind, intra-individual monocentric study was to evaluate in situ the antioxidant activity of a dermo-cosmetic product in photoaged skin. Twenty healthy volunteers had defined skin areas randomized to receive a topical product containing 3 antioxidants (pre-tocopheryl® , retinaldehyde and glycylglycine ole-amide), its vehicle and a positive antioxidant control cream. The products were applied daily for 30-day period. The skin areas were exposed to a controlled dose of UVA rays, and the skin oxidative status was evaluated 4 and 24 hours post-UVA exposure at D0 (basal value) and after 15 and 30 days of product application. Skin layers were collected by stripping, and antioxidant capacity was measured using the ferric reducing ability of a plasma assay. Lipid peroxidation (LPO) was assessed using the malonyldialdehyde test. The tested product significantly improved the skin antioxidant capacity after 15 and 30 days and significantly decreased the basal level of the skin LPO. The skin LPO level significantly decreased 4 and 24 hours after UVA exposure at 15 and 30 days. These findings were comparable to positive control treated sites and were significantly different from the vehicle and untreated sites. This minimally invasive methodology enabled a quantitative evaluation of potent antioxidant activity in situ in the stratum corneum reflecting real-life skin conditions and confirming the benefits of the topical application of a product containing 3 antioxidants in the prevention of UVA-induced oxidative damage.

A novel dermo-cosmetic product containing thermal spring water, sucralfate, copper sulfate, and zinc sulfate in the management of hand eczema.

BACKGROUND: The regular use of cosmetic products plays a role in the management of hand eczema (HE) and aids in improving barrier function reducing dryness, roughness, pruritus and improving quality of life (QoL). The aim of this open-label study was to assess the efficacy and the reparative effect of a dermo-cosmetic product on subjects suffering from HE after 7 and 21 days of daily application. METHODS: The product was a water-in-oil (W/O) emulsion containing the active ingredients Avène thermal spring water, sucralfate, and copper and zinc sulfates. In total, 32 subjects suffering from either contact dermatitis or climatic dermatitis participated in the trial. The modified total lesion symptom score and physician global assessment scores were used to describe the severity of HE. The safety of the product was assessed through clinical scoring. The subjective tolerance, and acceptance, were documented using a self-assessment questionnaire completed by the subjects. The impact of the dermatosis on QoL was evaluated using the Dermatology Life Quality Index. RESULTS: After 7 days of application, both the physician and subjects noticed a significant improvement in HE. The formula was very well tolerated and accepted. These benefits were correlated with a significant improvement in QoL. CONCLUSION: The W/O emulsion used in this study demonstrated real benefits for the subjects suffering from contact dermatitis and climatic dermatitis.

Balance between beneficial microflora and Staphylococcus aureus colonisation: in vivo evaluation in patients with atopic dermatitis during hydrotherapy.

BACKGROUND: The role of the balance between Staphylococcus aureus and commensal flora in the severity of atopic dermatitis (AD) lesions is not well understood. OBJECTIVES: To determine the structure of skin microbiome in patients with AD and its changes during an 18-day course of hydrotherapy and to assess the association between S. aureus and micro-organism colonisation, local skin condition and AD severity. METHODS: Three skin areas (xerotic, inflammatory and healthy) were identified in 25 moderate to severe AD patients for sampling before treatment, just after (day 1), and at day 10 and day 18. The structure of the bacterial community in the samples was assessed using a molecular biology approach based on 16S rRNA gene profiling. At each visit, AD severity was measured globally by the SCORAD index and at the lesional and healthy sampling sites. RESULTS: Clustering analysis of 296 samples showed two different bacterial community profiles: one with 2 peaks corresponding to S. aureus, the other displayed multiple peaks, identified as diversified microflora. At baseline, xerotic areas seemed to be less colonised by S. aureus than inflammatory areas. After 18 days of hydrotherapy, the number of lesional sites colonised by S. aureus (p<0.05) and the SCORAD index (p<0.00001) were significantly reduced, mainly in inflammatory and moist areas, promoting the emergence of a diversified microflora. CONCLUSIONS: We identified two bacterial community profiles corresponding to S. aureus and diversified microflora. The competitive balance between both profiles appears to be a key element associated with the severity of AD lesions.

To evaluate the efficacy and safety of "RV2427B" cream in Irritant dermatitis care.

BACKGROUND: The treatment of various irritant dermatitis involves the elimination of the casual or favoring factor, the control of aggravating factors, and administration of topical agents. Even though corticosteroids are extensively used in these conditions to reduce the inflammation, it can also result in undesirable side effects. Hence, there is a need for a non steroidal topical agent to be used in these conditions. AIMS: To evaluate the efficacy and tolerance of repairing cream RV 2427B in children and adults in irritant dermatitis care. MATERIALS AND METHODS: In this phase III open labeled, multicenter, non-controlled, non-randomized trial, irritant dermatitis in children and adults either due to diaper rash, pityriasis alba and irritant dermatitis (eczema), perioral dermatitis, perleche or intertrigo were administered; repairing cream RV 2427 B containing a) 4 % zinc oxide, b) 2.5 % dry colloidal oat extract, (c) 0.5 % oat oil, (d) 0.2% copper sulfate, and (e) 0.1 % zinc sulfate to be applied twice-daily in the affected area. The subjects were evaluated on day 7 and day 21 for both efficacy and tolerance and last visit for cosmetic acceptability. The trial was conducted in accordance with the good clinical practices (GCP) after obtaining ethical clearance from respective Institutional Review Boards. Statistical evaluation was by variance analysis and student test for the quantitative variables, chi-square test for the qualitative variables. RESULTS: Of the 136 enrolled subjects, 95 completed the study. After 21 days of treatment, 84% of the subjects assessed by the investigator and 76% by the self-assessment for the cream found effective. Investigational product was considered to be safe after 7 and 21 days of use. CONCLUSION: Repairing cream RV 2427 B is effective and safe in the management of irritant dermatitis.

Combined 0.1% retinaldehyde/ 6% glycolic acid cream in prophylaxis and treatment of acne scarring.

BACKGROUND: Acne often results in permanent, badly tolerated, difficult to treat scars. OBJECTIVE: To evaluate the efficacy and safety of a 0.1% retinaldehyde/6% glycolic acid (RALGA) cream at preventing and treating acne scarring in patients previously treated for moderate acne. METHODS: A double-blind vehicle-controlled study was conducted in 145 patients randomized to apply RALGAor vehicle cream every evening for 3 months. Global scarring score and patient's assessment of global efficacy, then residual acne lesions, quality of life and tolerance were evaluated at inclusion and each month until study completion. RESULTS: Global scarring score, number of inflammatory lesions and comedones significantly improved in each group from day 28 (p<0.0001). Number of inflammatory lesions were significantly decreased only in the RALGA group. RALGA cream was more efficient than vehicle on scarring after 3 months in compliant patients (p=0.007) due to erythema and hyperpigmentation improvement. CONCLUSION: RALGA cream is efficient at preventing and treating acne scarring in patients with moderate acne.