Evaluation of the Efficacy of an Ecobiological Dermo-Cosmetic Product to Help Manage and Prevent Relapses of Eyelid Atopic Dermatitis.

Purpose: Atopic dermatitis (AD) is a chronic relapsing, inflammatory disease which causes eczematous lesions. Itching and symptoms visibility can have a significant impact on quality of life. This is the case when eyelids are affected. Therefore, we evaluated a dermo-cosmetic product designed to care AD on eyelids. Subjects and Methods: An initial analysis of the product included 20 healthy women with no AD signs. A clinical evaluation of the effect of the product on AD sign severity was performed on 33 subjects presenting AD symptoms on eyelids. We also analyzed the product's capacity to prevent relapses in a parallel group clinical evaluation performed on 66 subjects. Results: First, on the forearm skin of healthy subjects, the product reduces erythema and decreases transepidermal water loss when used for 28 days. Second, when clinically evaluated on subjects with eyelid symptoms undergoing a corticoid treatment, the product leads to reduced AD signs scored by a dermatologist, better self-evaluation of symptoms by subjects, and improved quality of life. Besides, upon assessment in a randomized controlled clinical evaluation with subjects prone to AD relapses but without symptoms, the product also drastically reduces relapse frequency. If erythema reduction is the only sign identified by a dermatologist, the product greatly and rapidly improves the quality of life of subjects. Conclusion: These effects can be explained by the known actions of the product's ingredients. Rich in hydrating compounds, fatty acids and anti-inflammatory compounds, it aims at maintaining and restoring the epidermis structure and function to preserve it from irritants. It effectively shows that a daily care and hygiene routine with a dermo-cosmetic product designed according to an ecobiological approach leads to objective improvement of AD and subjective perception of quality of life.

Improvement of Quality of Life in Dialysis and Diabetic Patients by Skin Dryness and Pruritus Management with an Ecobiological Dermo-Cosmetic Product.

Purpose: Xerosis and pruritus are common chronic dermatological disorders among dialysis and diabetic patients that are frequently underdiagnosed or neglected, which can impact the quality of life of these patients. This study aimed to evaluate the efficacy and safety of a specific dermo-cosmetic product in the treatment of dry skin and pruritus associated with dialysis and diabetes. Patients and Methods: Twenty-nine dialysis patients (mean age 62 years) and 40 diabetic patients (mean age 57 years, 88% type 2) were included in two different single-center open-label uncontrolled clinical trials. All patients presented skin dryness according to the Scaling Roughness Redness and Cracks (SRRC) scale, and pruritus and/or insomnia. They applied the dermo-cosmetic product Medi-Secure Atoderm Xereane (NAOS, Laboratoire Bioderma) once or twice a day. The clinical efficacy (SRRC, pruritus, and insomnia), the skin-related quality of life (Dermatological Life Quality Index, DLQI), and the subjective efficacy were assessed at the inclusion visit and after 28 days of product application, as well as the safety. Results: After 28 days of application, the product significantly reduced the SRRC global score of 83% (0.9±0.8 vs 5.1±1.2) and 66% (1.4±1.2 vs 4.2±0.5), pruritus intensity of 76% (1.1±1.3 vs 4.6±2.1) and 78% (0.9±1.7 vs 4.2±2.6), and insomnia intensity of 61% (0.9±1.3 vs 2.4±2.3) and 82% (0.9±1.7 vs 4.8±2.7) in dialysis and diabetic patients, respectively. Furthermore, the product's application led to an improvement of the skin-related quality of life of 50% (5.4 vs 2.7; p<0.0001) in dialysis patients and 71% (6.6 vs 1.9; p<0.0001) in diabetic patients at D28. In addition, the product was greatly appreciated by all patients for its soothing, comforting, repairing, nourishing, and hydrating effects and was very well tolerated by the entire panels. Conclusion: This specific dermo-cosmetic product significantly reduces skin dryness, pruritus, and insomnia in dialysis and diabetic patients, thereby greatly improves their skin-related quality of life. By managing and avoiding bothersome symptoms associated with their disease or treatment, this ecobiological dermo-cosmetic can prevent serious complications that constitute a substantial burden on their daily life.

Tattoo aftercare management with a dermo-cosmetic product: Improvement in discomfort sensation and skin repair quality.

BACKGROUND: A moisturizer application during the healing process after a tattoo session is a common practice to help wound healing and to reduce discomfort sensations. This practice was recently recommended by the standard European guidelines on tattoos, with the use of an adapted ointment to keep the site moist. AIMS: To assess the efficacy and the tolerability of a specific dermo-cosmetic product (Cicabio Pommade, Laboratoire Bioderma, NAOS, France) in tattoo aftercare. PATIENTS/METHODS: Thirty subjects included in this survey applied the product immediately after the tattoo session for 14 days. The objective symptoms (redness, edema, skin repair quality) were assessed by the tattooist and the subjects. The subjective symptoms, discomfort sensations (pain, itching, burning sensations, tingling), soothing, moisturizing, and undesirable effects were assessed by the tattooed individuals. RESULTS: After 14 days of application, redness was absent for 100% and 96% of subjects according to the tattoo artist and the subjects, respectively, and edema had completely disappeared for both assessors. Most of the subjects rated the skin quality repair and the aesthetic outcomes as very good to excellent. Soothing and moisturizing effects were observed as early as the first day. The effects were maintained over 14 days. Discomfort sensations were judged absent to slight in 96%-100% of cases after 7 days. They were assessed as absent to slight in all cases for pain, itching, and tingling, and in 96% for burning sensations after 14 days. The product was very well tolerated by 87% of the subjects. CONCLUSIONS: Our survey demonstrates that this dermo-cosmetic product is suitable for tattooed skin aftercare as it reduced skin discomfort as soon as the first day and led to a good skin quality repair while being well tolerated.

Burden of Sensitive Skin (BoSS) Questionnaire and Current Perception Threshold: Use as Diagnostic Tools for Sensitive Skin Syndrome.

The assessment of sensitive skin syndrome, characterized by subjective unpleasant sensations, remains a challenge, since there is no international consensus on the best diagnostic tools. This study evaluated the combination of the Burden of Sensitive Skin (BoSS) questionnaire and the current perception threshold as diagnostic tools for sensitive skin syndrome, and the relationship between BoSS and the subjects' smoking status, phototype and skin type. A total of 100 women completed the BoSS questionnaire, and current perception threshold was measured on the face. The BoSS score was significantly higher in the self-reported sensitive skin group compared with the non-sensitive skin group (25.61 vs 14.05; p < 0.001), and in non-smokers vs smokers (23.00 vs 18.37; p < 0.05). In addition, the current perception threshold values were similar between the sensitive and non-sensitive groups. These results suggest that BoSS is a better diagnostic tool for sensitive skin syndrome than the current perception threshold, and that smokers less frequently have sensitive skin than do non-smokers.

Interest in Micellar Solution to Reduce Unpleasant Skin Sensations.

INTRODUCTION: The results from the "Objectifs Peau" project showed that approximately 30% of the French population complains of an unpleasant skin sensation at least once a day. Itching was the most frequent complaint (32%), followed by tingling (18.9%) and burning sensation (5.6%), which impact an individual's daily life. These sensations could be identified, as they were either isolated or associated with each other. The aim of this study was to evaluate the use of micellar solution to reduce these sensations, especially on sensitive skin. METHODOLOGY: A questionnaire was administered at Day 0 (D0), D2, D14, and D28 using a mobile phone application to individuals applying micellar solution (Sensibio H2O, Laboratoire Bioderma, NAOS) who spontaneously used micellar solution for sensitive skin and/or spontaneously consulted a health professional. Itching, tightness, tingling and burning sensations were evaluated by means of frequencies (never, rarely, sometimes, often or constantly) at D0, D2, D14 and D28. Responses from the questionnaire were rated (never=0, rarely=1, sometimes=2, often=3 or constantly=4) and allowed us to obtain an overall "unpleasant sensations" score, where a higher score corresponded to a higher degree of unpleasant sensations. RESULTS: In total, 400 evaluable individuals participated in the study (97% female, average age 38.5±13 years, 82% reported sensitive skin). The "unpleasant sensations" score improved from D2 and continued significantly on D14 and D28. The improvement rates were 47.7%, 57.9% and 62.7% at D2, D14 and D28, respectively, compared to D0. The percentages of improvement at D2, D14 and D28 were 83.2% (95% CI: 79.26; 87.21), 87.54% (95% CI: 84.01; 91.06) and 90% (95% CI: 87.06; 92.94), respectively, compared to D0. CONCLUSION: The improvement in the reduction of unpleasant sensations was observed as early as 2 days after using micellar solution and increased over time. The use of this type of micellar solution, especially on sensitive skin, and the guidance of health professionals (dermatologists and pharmacists) may help to reduce the impact of unpleasant skin sensations.

Inhibition of thymic stromal lymphopoietin production to improve pruritus and quality of life in infants and children with atopic dermatitis.

BACKGROUND: Atopic dermatitis (AD) is an inflammatory pruritic chronic dermatosis involving the alarmin thymic stromal lymphopoietin (TSLP), which is directly implicated in AD pruritus. AIMS: To evaluate the efficacy of Tambourissa trichophylla leaf extract (TTLE) titrated in polyphenols and 18ß-glycyrrhetinic acid (GA) in vitro and in vivo for AD pruritus. PATIENTS/METHODS: Initially, in vitro assessment of TSLP production in keratinocytes was undertaken. In normal human keratinocytes in vitro, TSLP was induced by polyinosinic:polycytidylic acid (Poly:IC), tumor necrosis factor (TNF)-α, and interleukin (IL)-4 and then quantified by ELISA in supernatants. Some cells were pretreated with TTLE and/or GA. Thereafter, an in vivo clinical study was performed including 48 infants and children with mild to severe AD flare-ups, some of which were treated with topical corticosteroids. A topical spray containing TTLE and GA was applied. After 21 days of topical spray application, pruritus, sleeplessness, the SCORing Atopic Dermatitis (SCORAD) index, the Infant's Dermatitis Quality of Life index (IDQOL), and the Dermatitis Family Impact Questionnaire (DFIQ) were assessed. RESULTS: Thymic stromal lymphopoietin secretion was inhibited significantly in an AD environment by TTLE and GA by up to 57.2% and 73.3%, respectively. The use of the topical spray induced a significant reduction in pruritus and sleeplessness scores, as well as the SCORAD, IDQOL, and DFIQ indexes in the total group. Similar results were observed in patient subgroups with or without topical corticosteroid treatment. CONCLUSIONS: A topical spray containing TTLE and GA, which inhibit TSLP secretion, efficiently decreases AD pruritus and improves the quality of life of AD patients.

Multimodal Clinical Imaging Assessment of the Outcome in Mild-to-Moderate Acne: A Prospective Study.

BACKGROUND: The quality of outcome assessment in acne studies has been either subjective/insufficient or time consuming through the ordinary lesion counting. OBJECTIVE: To evaluate the application of multimodal clinical imaging (MCI), a combination of imaging technology and computation, in the assessment of acne lesions in a clinical study setting. METHODS: A prospective, monocentric, single-group open study designed to evaluate the efficacy and tolerance of a cosmetic product (IP/SG) in subjects with mild-to-moderate facial acne by classical clinical counting (CCC) - change in the total/inflammatory/noninflammatory acne lesion number compared with baseline (D0) - Investigator Global Assessment (IGA) and self-reported outcomes. Concomitantly, MCI was administered. The study was performed for 12 weeks (D84) with a 4-week follow-up (D112). RESULTS: Mean age of patients (n = 49) was 18.2 ± 3.7 years (range 13-25). The mean acne duration was 3.8 ± 2.8 years. The total number of lesions did not differ significantly between D0/D84 by both CCC and MCI. However, the Cardiff Acne Disability Index (CADI) and uncomfortable feeling improved at D28/D0, the perception of oily skin improved at D14/D0, and the perception of sticky skin improved from D28/D0 to D56/D0. Deterioration was detected between D84/D0 and D112/D0, namely after product discontinuation. Interestingly, a change in trend was recorded for acne lesions at D14/D0 by MCI but not by CCC. CONCLUSION: MCI, applied for the first time in a small clinical study setting, is at least as reliable as CCC and may allow for a sensitive longitudinal evaluation of single acne lesions and their response to products, especially in conditions where clinical evaluation reaches its limits.

Assessment of a new biological complex efficacy on dysseborrhea, inflammation, and Propionibacterium acnes proliferation.

INTRODUCTION: Acne vulgaris is a common chronic inflammatory disease of the pilosebaceous unit triggered by Propionibacterium acnes. A bakuchiol, Ginkgo biloba extract, and mannitol (BGM) complex has been developed to provide patients with acne with a specific dermocosmetic to be used adjunctively with conventional treatments. OBJECTIVE: The aim of these studies was to assess the antibacterial, anti-inflammatory, and antioxidative potential of BGM complex and its individual compounds as well as its impact on sebum composition. METHODS: The antibacterial, anti-inflammatory, and antioxidative potential of BGM complex and its compounds was assessed through in vitro, ex vivo, and clinical studies. The clinical benefit of BGM complex formulated in a cream was assessed in subjects prone to acne through sebum composition analysis and photometric assessments. RESULTS: Results from the studies showed that the BGM complex has significant antibacterial, anti-inflammatory, and antioxidative properties. At similar concentrations, bakuchiol has up to twice the antioxidative potential than vitamin E. In subjects, BGM complex regulated the sebum composition in acne patients by increasing the level of sapienic and linolenic acid and reducing the level of oleic acid. The reduced number of porphyrins on the skin surface showed that it is also effective against P. acnes. CONCLUSION: BGM complex provides a complete adjunctive care in patients with acne by targeting etiopathogenic factors of acne: dysseborrhea, inflammation, and P. acnes proliferation.

A dermocosmetic containing bakuchiol, Ginkgo biloba extract and mannitol improves the efficacy of adapalene in patients with acne vulgaris: result from a controlled randomized trial.

BACKGROUND: Acne vulgaris is an inflammatory disorder of the pilosebaceous unit. AIM: To confirm that BGM (bakuchiol, Ginkgo biloba extract, and mannitol) complex increases the established clinical efficacy of adapalene 0.1% gel in patients with acne. METHODS: A clinical trial was conducted in acne patients. A total of 111 subjects received adapalene 0.1% gel and BGM complex or vehicle cream for 2 months. Assessments comprised Investigator Global Assessment (IGA), global efficacy, seborrhea intensity, inflammatory and non-inflammatory lesions, and subject perception, as well as overall safety and local tolerance and quality of life. RESULTS: At the end of the trial, inflammatory and non-inflammatory lesions, IGA, global efficacy, and seborrhea intensity had significantly improved in both treatment groups. Differences were statistically significant (P<0.05) in favor of BGM complex for inflammatory lesions as well as IGA and seborrhea intensity. Global efficacy assessments and subject perception confirmed the superiority of BGM complex-including treatment over the comparative combination. Quality of life had improved more with the active combination than with the vehicle combination. In the active group, four subjects had to interrupt temporarily BGM complex and 12 adapalene compared to seven subjects interrupting the vehicle and eleven adapalene in the vehicle group. One subject withdrew from the trial due to an allergy to adapalene. The majority of all events were mild. CONCLUSION: BGM complex improves the treatment outcome of adapalene 0.1% gel in patients with acne vulgaris. Overall, safety and local tolerance of BGM complex were good.

Efficacy and tolerance assessment of a new type of dermocosmetic in infants and children with moderate atopic dermatitis.

BACKGROUND: Atopic dermatitis (AD) is an inflammatory and pruritic skin disorder. OBJECTIVES: To assess the efficacy and tolerance of a new emollient (SBT complex) in subjects with moderate AD. METHODS: Subjects received twice daily for 168 days (6 months) either SBT complex or emollient base adjunctively or alternately with topical corticosteroids or calcineurin inhibitors. Evolution of AD was assessed throughout the study using usual AD assessment criteria including SCORAD and PO-SCORAD. Quality of life was assessed at Day 0 and Day 168. RESULTS: At Day 168, a significant decrease with SBT complex was observed for the SCORAD and the PO-SCORAD scores (P < 0.05), the primary efficacy criteria. A total of 76% of SBT complex subjects did not relapse and time-to-relapse increased compared to the emollient base subjects. Intensity, dryness, and quality of life (P < 0.05) had improved in subjects using SBT complex. The product was well tolerated with less physical and functional signs in the SBT than in the emollient base group. CONCLUSION: The new emollient dermocosmetic SBT complex applied adjunctively or alternately with topical AD treatments significantly improved AD without any safety concerns. SBT complex may play an important role in the restoration of the natural skin barrier.