Prevention of Polymorphic Light Eruption Afforded by a Very High Broad-Spectrum Protection Sunscreen Containing Ectoin.

INTRODUCTION: Polymorphic light eruption (PLE) is the most common idiopathic, acquired photodermatosis. The pathophysiology of PLE is not yet fully understood but seems to involve immunological mechanisms, UVA-induced oxidative stress, and the subsequent elicitation of a cellular stress response affecting keratinocyte gene expression and skin immune function. In the present study, a high broad-spectrum sunscreen medical device (MD), containing a very high protection complex of UVB and UVA filters and ectoin, was investigated for its ability to protect against UVA-induced PLE. METHODS: The study was carried out as a monocentric, double-blinded, randomized, untreated controlled design. The test MD was applied (2 mg/cm2) on one side of the chest according to a randomization list of 15 patients with a typical history of PLE, and the contralateral area remained untreated. After product application, the test areas were exposed daily to increasing doses of UVA radiation (from 40 to 60 J/cm2) until a PLE reaction was detected or for a maximum of five consecutive days. Evaluations of induced PLE included clinical scoring and chromametry for erythema and pigmentation. RESULTS: Overall, no positive PLE reaction was observed on the side of the chest treated by the test MD, whereas positive PLE reactions were triggered on the untreated side of 13 subjects. Subjective sensations were very rare on the MD-treated side but were numerous and more severe on the untreated side. Chromametry and clinical visual inspection indicated that the skin color was unchanged on the MD-protected side, whereas high increased values of erythema and pigmentation were observed on the untreated chest side. CONCLUSION: This MD sunscreen based on a complex of UVA-UVB filters and 1% of ectoin may be effective in preventing UVA-induced PLE. New studies comparing this MD sunscreen versus the same product without ectoin should be conducted. CLINICALTRIALS: gov identifier: NCT05320315 (retrospectively registered 09/17/2021).

Night Cream Containing Melatonin, Carnosine and Helichrysum italicum Extract Helps Reduce Skin Reactivity and Signs of Photodamage: Ex Vivo and Clinical Studies.

INTRODUCTION: Extrinsic factors, such as solar radiation and urban pollution, cause damage that alters the structure, function and appearance of skin. The aim of this study was to determine the ability of a night cream containing melatonin, carnosine and Helichrysum italicum extract (referred to here as Night Cream) to reduce extrinsic skin damage, and to evaluate the efficacy of this Night Cream to reduce clinical signs of age and photodamage under normal conditions of use. METHODS: Recovery from extrinsic damage was assessed by exposing human skin explants to ultraviolet (UV) A, infrared light, blue light or pollution and then treating the stress-exposed explants with Night Cream. Markers of oxidative stress were examined by immunohistochemistry. Anti-aging and calming properties were determined in four single-center, open-label trials involving 117 individuals. Subjects applied Night Cream to their face once nightly for up to 12 weeks. Improvements in clinical signs of age and photodamage, and reduction of lactic acid-induced stinging were evaluated by investigator assessment and subject self-assessment. RESULTS: Night Cream significantly reduced oxidative stress in human skin ex vivo. Clinically, hydration (+ 64.4%; p < 0.05) and transepidermal water loss (TEWL) values (- 10.0%; p < 0.05) were improved within 1 h of use. Wrinkle counts were reduced by up to 18.9% (p < 0.05), and brown and UV spot numbers by 5.5% (p < 0.05) and 13.2% (p < 0.05), respectively. Lactic acid-induced stinging was significantly reduced within 7 days of use, with 86.7% of subjects reporting that their skin felt calmer. CONCLUSION: These findings suggest that Night Cream reduces skin damage caused by environmental factors and that its nightly use can improve clinical signs of aging with additional skin calming benefits.

Efficacy and Acceptability of a New Water-Soluble Nail Strengthener Containing Pistacia lentiscus and Hyaluronic Acid to Improve the Appearance of Brittle Nails versus Untreated Nails: In vitro and Clinical Evidence.

INTRODUCTION: Brittle nail syndrome is characterized by dry, weak, easily breakable nails that show inelasticity, splitting and overall nail plate fragility. OBJECTIVE: This paper describes in vitro and clinical studies using bovine hooves designed to assess the efficacy, compatibility and acceptability of a water-soluble nail strengthener (WSNS), containing Pistacia lentiscus and hyaluronic acid, for the treatment of patients affected by brittle nails. METHODS: In the in vitro study, the WSNS was tested versus placebo and a marketed product on bovine hoof membranes, applied once daily for 14 days for evaluation of firmness, viscoelasticity and thickness before and after applications. In a clinical study, 23 female subjects affected by brittle nails were included, and the WSNS was applied once daily for 3 months. Signs and symptoms were rated by the investigators and by the participants during treatment at 28 and 84 days with different methods and dermoscopic images. Subjective efficacy was evaluated by specific questionnaires. RESULTS: In the in vitro study, the daily application of the WSNS and marketed product led to a significant increase in firmness index. In the clinical study, the nails on the treated hand presented an improvement in nail appearance and weakness, after 28 and 84 days of WSNS application, respectively. The nails not treated showed no improvement. The WSNS was well tolerated. CONCLUSIONS: The WSNS containing Pistacia lentiscus and hyaluronic acid was shown to significantly increase nail firmness in the in vitro study. In the clinical study, WSNS significantly improved brittle nail appearance. The hydrosolubility and easy-to-apply format of WSNS were reported to be factors of a good compliance. We consider this product as an important tool to improve and reinforce the aspect of brittle nails.

Prospective Evaluation of the Efficacy of a Food Supplement in Increasing Photoprotection and Improving Selective Markers Related to Skin Photo-Ageing.

INTRODUCTION: Skin exposure to ultraviolet radiation (UVR) can cause oxidative stress, particularly in the absence of adequate protective measures or in individuals with a sensitive skin type. Most commonly, protection from UVR entails the use of topical sunscreens. Sunscreens, however, have various limitations. The objective of this study was to evaluate the efficacy and tolerability of an oral food supplement containing a combination of actives with mainly antioxidative properties (vitamins A, C, D3, E, selenium, lycopene, lutein, as well as green tea, polypodium and grape extracts) in the context of photoprotection. METHODS: Photoprotective efficacy was assessed in a 12-week-long, open, prospective and monocentric clinical study with 30 subjects (27 women and 3 men) having a Fitzpatrick skin type I-III and manifesting clinical ageing signs. The study included several visits (14, 28, 56, and 84 days after starting supplement intake), in which photoprotection was evaluated by the measurement of the minimal erythema dose (MED), while the antioxidant capacity of the skin was assessed through ferric reducing antioxidant power (FRAP) and malondialdehyde (MDA) assays. Additionally, several skin parameters (including radiance, elasticity, and moisture) were evaluated. Product evaluation was performed throughout the length of the study by means of a self-assessment questionnaire, and safety was monitored through a self-recording of all observed adverse reactions. RESULTS: The MED levels increased significantly compared to baseline throughout the study visits, reaching an increase of + 8.1% at T84, p < 0.001. FRAP results also indicated a significant increase in the antioxidant capacity of the skin compared to baseline (+ 22.7% at T84, p < 0.001), while the MDA assay showed a significant decrease in MDA concentration compared to baseline (- 6.4% at T84, p < 0.001) which, in line with the FRAP results, indicated enhanced antioxidative protection of the skin. All assessed skin parameters, including radiance (+ 36.1% at T84, p < 0.001), gross elasticity (+ 13.2% at T84, p < 0.001), net elasticity (+ 28.0% at T84, p < 0.001), and moisture (+ 13.8% at T84, p < 0.001) were also significantly improved. The product was well tolerated as no adverse events were attributed by the investigators to the use of the product. Additionally, the global score obtained from the self-assessment questionnaires provided overwhelmingly positive feedback from the study subjects. CONCLUSIONS: The food supplement evaluated in this study was effective and well-tolerated by the subjects, demonstrating a beneficial effect in terms of photoprotection, enhancing the antioxidative status of the skin and improving general skin condition. TRIAL REGISTRATION: Retrospectively registered 3rd October 2019, ISRCTN18121679.

Use of Topical Nitric-Zinc Complex Solution to Treat Palmoplantar and Periungual Warts in a Pediatric Population.

INTRODUCTION: Nitric-zinc complex solution (NZCS) is a topically applied solution containing nitric acid, zinc, copper, and organic acids that induce a painless caustic effect on "difficult-to-treat" warts, including palmoplantar and periungual locations. The objective of the present prospective clinical study was to describe the efficacy and tolerability of NZCS in the treatment of palmoplantar and periungual warts in children. METHODS: Eligible patients were immunocompetent children and adolescents, with at least one palmoplantar or periungual wart. NZCS was topically applied every 2 weeks in clinic. Efficacy was recorded by clinical evaluation, and acceptability assessments were measured using a visual analogue scale (VAS). RESULTS: Pediatric patients (N = 12) were equally distributed by gender, and the mean age was 9.60 ± 3.34 years. The youngest patient was 4 years old. A total of 31 warts were identified: 24 periungual warts (77.4%), 2 palmar warts (6.45%), and 5 plantar warts (16.12%). We observed complete resolution in 83.9% of the warts treated with NZCS, achieving total cure considered as therapy success in 87.5% of periungual warts and 71% of palmoplantar warts, with a mean of 6.0 treatment sessions. The esthetic results evaluated by the investigator were considered excellent in 83.3% of cases and good in 16.7%. In 100% of the completely resolved cases, no scars, erythema, hyperpigmentation, hypopigmentation, or hypertrophy in the area surrounding the treated warts were observed by the investigator. The esthetic results evaluated by the patients or parents/guardians were excellent. Pain and burning sensation were minimal and well tolerated. No clinically relevant adverse events were reported. CONCLUSION: NZCS was an effective treatment of warts in this pediatric population. The painlessness, simplicity, and twice-monthly dosing regimen of this treatment represents an advantage over standard approaches. FUNDING: ISDIN. TRIAL REGISTRATION: Retrospectively registered 6 September 2019, ISRCTN90862249.

A novel Nitrizinc Complex® solution for topical treatment of seborrhoeic keratosis: an interventional clinical study.

Seborrheic keratosis (SK) is a benign, common disease affecting mostly the middle aged and elderly population. SK lesions are characterized by pigmented skin growth, a warty surface, and sharp margins. Current therapies (curettage or cryotherapy) are invasive and painful. A non-invasive treatment is evaluated in this clinical study. Objectives: To assess the efficacy, safety, and tolerability of Nitrizinc Complex® topical solution (NZCS) for treatment of SK, after one to two topical applications. Thirty-two SK patients with a total of 59 lesions were treated with NZCS. Outcomes were determined by the dermatologist at clinical visits at one, three, six, and 12 months post-procedure and by subjective evaluation of patients through questionnaires. Six months after treatment, complete elimination was observed in 80% of the lesions (72% of the patients), while 93.3% of the lesions showed at least 50% reduction. Treatment ended with 100% cosmetic benefit as no scars or dyschromia were observed in the treated areas. Subjective treatment and cosmetic satisfaction were evaluated and corresponded to 8.66/10 and 8.07/10, respectively. The product was preferred over all other options previously used by all patients. Treatment was highly tolerable as discomfort, such as pain and itching/burning sensations, was minimal. No relapse cases have been observed at 12 months after treatment. This study demonstrates that NZCS is an efficient, easy-to-apply, safe and well tolerated treatment for SK lesions, and may therefore be considered as a potential topical non-invasive alternative for SK treatment.

Adherence to drug treatments and adjuvant barrier repair therapies are key factors for clinical improvement in mild to moderate acne: the ACTUO observational prospective multicenter cohort trial in 643 patients.

BACKGROUND: In acne, several studies report a poor adherence to treatments. We evaluate, in a real-life setting conditions, the impact of compliance to physician's instructions, recommendations and adherence to the treatments on clinical outcome in patients with mild to moderate acne in an observational, non-interventional prospective study carried out in 72 Dermatologic Services in Spain (ACTUO Trial). METHODS: Six-hundred-forty-three subjects were enrolled and 566 patients (88 %) completed the 3 study visits. Study aimed to evaluate the impact of adherence (assessed with ECOB scale) on clinical outcome, as well as how the use of specific adjuvant treatments (facial cleansing, emollient, moisturizing and lenitive specific topical products) influences treatment's adherence and acne severity (0-5 points score). Recommendation of specific adjuvant skin barrier repair products was made in 85.2 %. RESULTS: Overall, clinical improvement was observed throughout follow-up visits with an increased proportion of patients who reported reductions of ≥50 % on the total number of lesions (2 months: 25.2 %; 3 months: 57.6 %) and reductions of severity scores (2.5, 2.0 and 1.3 at 1, 2 and 3 months after treatment, respectively). Adherence to treatment was associated with a significant reduction on severity grading, a lower number of lesions and a higher proportion of patients with ≥50 % improvement. CONCLUSIONS: Good adherence to medication plus adherence to adjuvants was significantly associated with a higher clinical improvement unlike those that despite adherence with medication had a low adherence to adjuvants. A good adherence to adjuvant treatment was associated with improved adherence and better treatment outcomes in mild to moderate acne patients. (ISRCTN Registry: ISRCTN14257026).