Real-world effectiveness and tolerability of a cream containing postbiotic Aquaphilus dolomiae extract-G3 in subjects with sensitive facial skin.

Previous studies indicate that a postbiotic extract from Aquaphilus dolomiae (ADE-G3) improves skin barrier function and relieves neuroinflammation. Evaluation of an ADE-G3-based soothing cream for managing sensitive facial skin. This real-world, international, pre-post comparative study involved adults with sensitive facial skin who used the study product once or twice daily for two to three months according to usual practice. Subjects reported changes in perceived clinical symptoms using self-administered questionnaires. Physicians assessed changes in xerosis severity, overall product effectiveness and tolerability. User satisfaction and quality of life (QoL) assessments, and subgroup analyses according to the factors triggering sensitive skin were also conducted. In total, 2,382 subjects with sensitive facial skin (female: 79%; median age: 40 years) were included. An immediate skin soothing effect after the first ADE-G3-based cream application was reported by 93% of subjects, and improvements in symptoms were reported in 94% after a mean of nine days of product use. After several months of use (mean: 71±21 days), xerosis severity and dermatological-related QoL significantly improved in the whole study population and in the subgroups (p<0.001). At the end of the study, 92% of users were satisfied with the product and 95% reported improvements in their overall skin condition. Physicians found the cream to be effective and well tolerated in 92% and 98% of subjects, respectively. Regular use of the ADE-G3-based cream was shown to be effective in real-world management of sensitive facial skin, regardless of the factors involved in triggering skin sensitivity.

Influence of cosmetic foundation cream on skin condition during treadmill exercise.

BACKGROUND: There is a growing trend of individuals wearing cosmetics while participating in physical activities. Nonetheless, there remains a need for further understanding regarding the effects of makeup on the facial epidermis during exercise, given the existing knowledge gaps. PURPOSE: This study aimed to evaluate the effects of a cosmetic foundation cream on skin conditions during physical activity. METHODS: Forty-three healthy college students, 20 males (26.3 ± 1.5 years) and 23 females (23.1 ± 1.0 years), were enrolled in this study. Foundation cream was applied to participants on half of the face in two different areas (MT: makeup T zone and MU: makeup U zone). The other half of the face served as internal control (T: non-makeup T zone and U: non-makeup U zones). Skin levels of moisture, elasticity, pore, sebum, and oil were measured using a skin analysis device (Aramhuvis, Gyeonggi, Republic of Korea) before and after a 20-min treadmill exercise. Paired t-test and independent t-test were performed for skin condition measurements at pre- and postexercise. RESULTS: The skin moisture levels in both the T and MT significantly increased after exercise (p < 0.05) (pre-T: 24.5 ± 1.3, post-T: 38.5 ± 3.5 and pre-MT: 18.7 ± 0.7, post-MT: 40.4 ± 4.8). Elasticity also significantly improved in both the T and MT (p < 0.05) (pre-T: 25.6 ± 1.3, post-T: 41.5 ± 3.5 and pre-MT: 20.0 ± 0.9, post-MT: 41.7 ± 3.7). The size of the pores in the T zone observed a significant increase after exercise (p < 0.05) (pre-T: 41.7 ± 2.1, post-T: 47.8 ± 2.4). The sebum levels in the T zone exhibited a reduction following physical activity, whereas there was a notable increase in sebum levels in the makeup zones (p < 0.05) (pre-MT: 2.4 ± 0.7, post-MT:4.2 ± 0.8 and pre MU 1.8 ± 0.34, post MU 4.9 ± 0.9). The oil level was increased in the non-makeup zones (pre-T: 6.1 ± 1.4, post-T: 11.8 ± 2.0 and pre-U: 7.3 ± 1.5, post-U: 11.9 ± 1.9; p < 0.05) and decreased in the makeup zones (pre-MT: 13.3 ± 1.9, post-MT: 7.4 ± 2.3 and pre-MU: 22.1 ± 2.4, post-MU: 3.2 ± 1.0; p < 0.05). CONCLUSIONS: The findings suggest that using foundation cream during aerobic exercise can reduce skin oil, causing dryness. Additionally, makeup can clog pores and increase sebum production. Therefore, wearing makeup may not be recommended for people with dry skin conditions based on the results of the current study. This research offers important insights to the public, encouraging them to consider the possible consequences of using makeup while exercising.

Combination of 5% cysteamine and 4% nicotinamide in melasma: Efficacy, tolerability, and safety.

BACKGROUND: Melasma is a chronic dermatosis that impacts the patient's quality of life and can present considerable challenges in terms of effective treatment. OBJECTIVE: To evaluate the effectiveness, tolerability, and safety of 5% cysteamine combined with 4% nicotinamide in female subjects with melasma. METHODS: This single-center, single-arm, prospective, open-label study evaluated patients with melasma using a combination cream of 5% cysteamine and 4% nicotinamide in a progressive regimen (60 min in the first month, 120 min in the second month, and 180 min in the third month). RESULTS: Overall, 35 treated subjects exhibited reduced modified Melasma Area and Severity Index (mMASI) (p < 0.001) and decreased MelasQoL scores (p < 0.001), accompanied by improved brightness, luminosity, homogeneity, and spot intensity (p < 0.001). Photographic and colorimetric analysis revealed smaller spots and improved homogeneity. LIMITATIONS: Adherence to progressive daily treatment could not be evaluated long-term. CONCLUSION: A combination cream comprising 5% cysteamine and 4% nicotinamide was effective, tolerable, and safe for treating melasma.

Efficacy of ceramides and niacinamide-containing moisturizer versus hydrophilic cream in combination with topical anti-acne treatment in mild to moderate acne vulgaris: A split face, double-blinded, randomized controlled trial.

INTRODUCTION: Topical therapy is the mainstay treatment of acne, and topical retinoids such as tretinoin, tazarotene, and adapalene are recommended as the first-line therapy for mild to moderate acne. However, the cutaneous irritations may occur, and the dermocosmetics are recommended to prevent side effects of anti-acne drugs and adhere to treatment. Thus, this study aims to compare the efficacy and tolerability of ceramides and niacinamide-containing moisturizer (CCM) versus hydrophilic cream in combination with topical anti-acne treatment in mild to moderate acne vulgaris. METHODS: This was an 8-week, randomized, double-blinded, split face study in 40 patients assigned for topical anti-acne medications (5% benzoyl peroxide and 0.1% adapalene gel), then randomly applied CCM or hydrophilic cream. All patients were followed at week 0, 2, 4, and 8 for acne improvement, adverse reactions, biometric, and biophysical evaluation. RESULTS: CCM could significantly improve the non-inflammatory, inflammatory, and total acne lesions compared with hydrophilic cream after week 8 of treatment. Interestingly, there was an improvement of global worst score, hemoglobin index, melanin index, TEWL, skin hydration, sebum production, and skin surface pH, with no statistically significant differences between the two treatments. No serious side effects from clinical application of CCM and hydrophilic cream in mild to moderate acne vulgaris patients. CONCLUSION: Ceramide and niacinamide-containing moisturizer in combination with anti-acne medication can significantly improve acne lesions and decrease cutaneous irritations toward a satisfactory treatment outcome of mild to moderate acne vulgaris.

Comparison of the effect of topical triamcinolone 0.1% cream with sulfur 2.0% cream in the treatment of patients with hand eczema: A randomized controlled trial.

BACKGROUND: Hand eczema (HE) is a common and heterogeneous condition. It has a wide range of etiologies and clinical manifestations. In this study the efficacy of triamcinolone 0.1% cream and sulfur 2% creams was compared in treating patients with HE. METHODS: This randomized, triple-blind clinical trial was performed on 70 patients with HE (including 70 right and 70 left hands). In this study, two creams were used including triamcinolone 0.1% and sulfur 2.0%. Patients were treated with these creams twice a day (once in every 12 h) for 4 weeks. Follow-up was 4 weeks after treatment. Hand Eczema Severity Index (HECSI), itching, dryness, burning sensation, and erythema scores were collected three times during the study and compared between treatment regimens. RESULTS: Findings showed that both triamcinolone (0.1%) and sulfur (2.0%) creams could significantly reduce the scores of HECSI, itching, dryness, burning sensation, and erythema, and the therapeutic effects lasted for at least 4 weeks after cessation of topical treatment. CONCLUSION: Topical sulfur cream (2.0%) is as effective as triamcinolone (0.1%) cream in treatment of HE without any prominent adverse reactions.

Halobetasol Propionate 0.01% and Tazarotene 0.045% Lotion With a Ceramide-Containing Moisturizer in Adults With Psoriasis.

INTRODUCTION: Moisturizers are often used as adjuvant therapy for psoriasis to assist with rehydration and skin barrier restoration. Fixed-combination halobetasol propionate 0.01% and tazarotene 0.045% lotion (HP/TAZ) is indicated for the topical treatment of plaque psoriasis in adults, with a demonstrated clinical profile in two phase 3 trials. However, the effect of application order with HP/TAZ has yet to be explored. This study evaluated the clinical profile of HP/TAZ applied before versus after a ceramide-containing moisturizer in adults with mild-to-moderate plaque psoriasis. METHODS: Sixteen participants were randomized to apply HP/TAZ followed by moisturizer on one side and moisturizer followed by HP/TAZ on the other side once daily for 12 weeks. Tolerability, safety, efficacy, and quality of life endpoints were assessed.  Results: Significant Investigator's Global Assessment improvement was observed across all time points (P≤0.003) regardless of application order. Total Dermatology Life Quality Index scores significantly improved at all time points (P≤0.003), and visual analog scale for itch significantly improved at weeks 4, 8, and 12 (P<0.008). Four moderate adverse events were experienced by 3 participants. Two participants reported itching/irritation, which was worse when HP/TAZ was applied first. CONCLUSIONS: The application order of moisturizer did not decrease therapeutic efficacy of HP/TAZ. Moisturizer application before HP/TAZ may reduce incidence of application site adverse events, ultimately increasing tolerability and supporting the real-world recommendation that applying a ceramide-containing moisturizer before HP/TAZ, versus after, results in a safe and effective therapeutic option for plaque psoriasis. J Drugs Dermatol. 2024;23(2):50-53.     doi:10.36849/JDD.7928.

Revitalizing the skin: Exploring the role of barrier repair moisturizers.

BACKGROUND: Moisturizers are designed to maintain skin health and treat dermatological conditions associated with impaired skin barrier function. However, differences in their composition account for the differences in their effect. AIMS: This narrative review aims to discuss the role of barrier repair moisturizers, highlight the role of different components in a moisturizer and their role in impaired skin conditions (e.g., dry, itchy, inflamed, sensitive skin, atopic eczema), and thereby empower dermatologists and pediatricians in selecting the right moisturizer. METHODS: PubMed, Embase, and Scopus electronic databases were searched from January 2000 to June 2023 for publications on skin barrier repair and use of barrier repair moisturizers for the treatment of dry, itchy, inflamed, sensitive skin, or atopic eczema. Studies conducted in humans, published in English for which full texts were freely available were included. RESULTS: The structure and composition of lipid lamellae within the stratum corneum play an important role in maintaining an effective skin barrier and protecting the body from various external assaults. Endocannabinoid mediators play an active role in maintaining skin barrier function. Moisturizers containing physiological lipids and functional ingredients (e.g., endocannabinoids such as palmitoylethanolamide [PEA]) and based on the principles of biomimic technology are demonstrated to be beneficial for the management of conditions associated with a disrupted skin barrier. CONCLUSIONS: Moisturizer based on the innovative biomimic formulation has good cosmetic efficacy and is generally well tolerated, and the addition of PEA might represent a new generation of compounds that may be beneficial for long-term management of impaired skin conditions.

Unraveling the mirage of fairness cream commercials: A cross-sectional analysis of commercials from South Asia.

BACKGROUND: Fairness products are an essential component of daily beauty routines for many individuals in subcontinental Asia. However, it is important to be aware that these products often contain ingredients that can be detrimental to the skin and are banned in several developed countries. OBJECTIVE: Our study aims to analyze the content of fairness cream commercials in order to gain a deeper understanding of the information used to persuade and influence consumers to use these products. METHODS: Fairness cream commercials originating from countries in subcontinental Asia, including India, Pakistan, Bangladesh, Sri Lanka, and Nepal, were specifically searched and analyzed on the YouTube platform. RESULTS: An analysis of 152 fairness cream commercials on YouTube identified 84.21% of commercials targeted female consumers, while only 15.79% targeted male consumers. 77.63% of commercials used celebrities in their commercials and 47.37% of commercials mentioned specific ingredients. CONCLUSIONS: Based on our findings, it is crucial for dermatologists to take an active role in educating patients and consumers about the potential risks associated with certain ingredients found in fairness creams. Dermatologists should emphasize the importance of prioritizing overall skin health rather than solely focusing on skin lightening.

Efficacy of topical gabapentin in women with primary macular amyloidosis: A side-by-side triple-blinded randomized clinical trial.

BACKGROUND: Primary cutaneous macular amyloidosis (PCMA) is a chronic pruritic cutaneous disease characterized by heterogeneous extracellular deposition of amyloid protein in the skin. AIMS: This study aimed to evaluate the efficacy of topical 6% gabapentin cream for the treatment of patients with PCMA. MATERIALS AND METHODS: In this triple-blind clinical trial, a total of 34 patients, who were diagnosed with PCMA, treated using two different strategies of topical gabapentin as the active group and vehicle cream as the control group. RESULTS: Pruritus score reduction in both groups was statistically significant compared with the baseline value (p < 0.001). There was a significant pigmentation score reduction in intervention group compared with control group after 1 month of the study (p < 0.001). The differences of pigmentation score changes between the groups were not significant at month 2 (p = 0.52) and month 3 (p = 0.22). CONCLUSIONS: The results of this study suggest that topical gabapentin cream may be effective as a topical agent in the treatment of pruritus associated with PCMA without any significant adverse effects. It is recommended to perform similar studies with a larger sample size and longer duration in both sexes.

Efficacy of castor oil cream in treating infraorbital hyperpigmentation: An exploratory single-arm clinical trial.

INTRODUCTION: Infraorbital hyperpigmentation represents one of the most prevalent conditions in cosmetic dermatology. To treat this condition, many patients prefer natural remedies. This study explored the efficacy of topical castor oil cream in treating patients with infraorbital hyperpigmentation. METHODS: We conducted an exploratory single-arm clinical trial at the Shahid Faghihi Dermatology Clinic and Molecular Dermatology Research Center of Shiraz University of Medical Sciences, Shiraz, Iran, during 2021-2022. Using the convenience sampling method, we enrolled 25 patients with infraorbital hyperpigmentation. We instructed the patients to apply topical castor oil cream twice daily for 2 months. The darkness, melanin, and erythema levels were evaluated by VisioFace® 1000 D and SkinColorCatch® devices. We used a visual analog scale to assess skin laxity, wrinkles, and patient satisfaction. Data analysis was done with Stata version 14.2. RESULTS: The data of 22 patients with a mean age of 40.92 ± 7.33 years were analyzed. The VisioFace® scores decreased significantly by the end of the study [right eyes: mean difference (MD): -5.63 (95% CI: -7.12 to -4.15), p < 0.001; left eyes: MD: -5.91 (95% CI: -7.46 to -4.36), p < 0.001]. Moreover, castor oil cream significantly reduced the melanin level, wrinkles, and skin laxity in the infraorbital region (p < 0.05). CONCLUSIONS: Castor oil cream seems to be an effective alternative for treating infraorbital hyperpigmentation. Randomized clinical trials are needed to confirm our findings.

A novel hydrogel-based moisturizing cream composed of hyaluronic acid for patients with xerosis: An intraindividual comparative analysis.

BACKGROUND: Hyaluronic acid (HA) is mainly used to treat xerosis. It also exerts wound-healing, moisturizing, and antiaging effects. Although HA is considered an effective and safe ingredient in cosmetics, there is a constant demand for a more money-saving and effective formulation. This study aimed to evaluate the safety and efficacy of a novel hydrogel-based moisturizer containing HA cross-linked with silicone polymers, produced solely through irradiation without the use of cross-linking agents. MATERIALS AND METHODS: A safety study enrolled 30 participants with healthy skin to perform patch and photopatch tests while recording adverse events. For the efficacy study, 30 participants with xerosis were compared before and after using the novel hydrogel, evaluating the cutaneous barrier function, xerosis severity scale (XSS) score, participant's satisfaction, and Investigator's Global Assessment (IGA). Furthermore, the efficacy of the novel hydrogel-based moisturizer was evaluated by comparing it with a conventional moisturizer, Physiogel, in another 30 participants with xerosis. RESULTS: In the safety study, no serious adverse events were observed. In the efficacy study before and after use, skin hydration and skin surface lipid increased (p < 0.05) whereas the XSS scores decreased (p < 0.05) with time. In the comparative efficacy study with Physiogel, skin hydration increased whereas the XSS scores decreased (p < 0.05) over time in both groups. Furthermore, IGA improved in 100% of participants in both groups. Also, 100% and 93% of participants were satisfied with the novel hydrogel-based moisturizer and Physiogel, respectively. CONCLUSIONS: The novel hydrogel-based moisturizer proved to be safe and effective for xerosis, showing comparable results to the conventional moisturizer.

Individual Article: Over-the-Counter Moisturizers Significantly Improve Skin Hydration in Adults With Eczema/Atopy-Prone Skin.

BACKGROUND: Many adults suffer from dry, itchy skin, particularly those with eczema-prone skin. This study evaluated the effects of two over-the-counter (OTC) moisturizing products on skin hydration, transepidermal water loss (TEWL), ceramide levels, and patient experience. METHODS: Single-center, randomized, double-blind, split-body study evaluating the effectiveness of an Eczema Soothing Moisturizer (ESM) versus an Itch Relief Moisturizing Lotion (IRML) applied twice daily for 4 weeks in healthy adults with self-perceived persistent mild-to-moderate eczema-prone skin. Assessments included corneometer for skin hydration, evaporimeter for TEWL, tape stripping to measure ceramide NS and AS levels on the skin of the arm and leg, and a self-assessed participant-reported outcome questionnaire. RESULTS: A total of 30 adults completed the study. Both products significantly increased hydration, but the effect of ESM was greater than IRML (P=0.001), and both significantly decreased TEWL. At week 4, there were increases in NS and AS ceramides at both the legs and arms for both products (P<0.05 vs BL). Individually, ceramide content was significantly improved for ESM in the leg and for IRML in the arm at week 4 (P<0.05 vs BL). Participant photos show ESM was beneficial across a range of skin phototypes. Both products resulted in favorable perceptions from study participants. CONCLUSIONS: These moisturizers improved skin hydration, skin barrier, ceramide levels in the skin, and were well-perceived by the participants. This suggests that both products are beneficial for patients with eczema and eczema-prone skin. However, the hydrating effect of ESM was significantly greater than IRML. J Drugs Dermatol. 2023;22:10(Suppl 2):s16-20.

Design and development of a facial Serum with Lactobacillus fermentum CECT 5716 / Diseño y elaboración de un sérum facial con Lactobacillus fermentum CECT 5716

Introducción: De todos los órganos del cuerpo, la piel es el que está directa y constantemente expuesto a agentes externos. De ahí la importancia de proporcionarle todos los nutrientes necesarios para mantenerla sana, cuidada e hidratada. Con esta intención se ha diseñado y desarrollado un sérum hidratante con ingredientes activos naturales que incluye una cepa de la especie probiótica Lactobacillus fermentum CECT 5716, como innovación, para potenciar el efecto sinérgico del producto. Método: El producto citado ha sido caracterizado mediante determinaciones de pH, conductividad y viscosidad para probar su estabilidad. Además, se ha estudiado la viabilidad del probiótico y la percepción de los consumidores en estudios de eficacia del producto. Resultados: Los datos extraídos de las mediciones de pH y conductividad aseguran que la aplicación tópica del sérum es segura, al igual que la percepción de eficacia del producto por los consumidores, ofreciendo una mejor apariencia en términos de suavidad y luminosidad. Además, esta investigación ha revelado las características pseudoplásticas del sérum, óptimas para su propósito. Por último, se ha visto que la viabilidad probiótica disminuye con el tiempo. Conclusiones: En base a los resultados obtenidos, se puede afirmar que nuestro sérum hidratante es seguro y eficaz en la hidratación cutánea, debido a las propiedades de las materias primas incorporadas y el mecanismo competitivo de los probióticos incluidos. (AU)

Introduction: The skin is of all the organs of the body that is directly and constantly exposed to external agents. Hence the importance of providing all the necessary nutrients to keep it healthy, cared for and hydrated. When this does not happen, the skin begins to lose water, becomes dehydrated, and can be seriously injured. With this inten-tion, a moisturizing serum with natural active ingredients has been designed and developed. It has been developed and characterized through various studies. In addition, it includes a strain of the probiotic species Lactobacillus fermentum CECT 5716, as an innovation, to enhance the synergistic effect of the product.Method: The cited product is characterized by pH, conductivity, and viscosity measurements to test its stability. Besides it is studied to probiotic viability and consumers’ perception of the product’s efficacy.Results: Data extracted from pH and conductivity measurements assure that the topical application of our serum is safe, as it does the consumers’ perception of the product’s efficacy study, offering it a better appearance in terms of smoothness and luminosity. This research has revealed the serum’s pseudoplastic characteristics, optimal for its purpose. Lastly, it has been seen that probiotic viability decreases with time.Conclusions: Based on the results we obtained; it can be affirmed that our moisturizing serum is safe and effective in skin hydration, due to the properties of the raw materials incorporated and the competitive mechanism of the probiotics included. (AU)

A 1% colloidal oatmeal OTC cream is clinically effective for the management of mild to moderate atopic dermatitis in Black or African American children.

BACKGROUND: The efficacy and safety of an over-the-counter (OTC) 1% colloidal oatmeal cream versus a ceramide-based prescription barrier cream in children with mild-to-moderate atopic dermatitis (AD) were previously described. OBJECTIVES: Here, findings are reported for the Black/African American subgroup. METHODS: Patients were randomized to 1% oatmeal cream or prescription barrier cream twice daily or as needed for three weeks. Assessments included Eczema Area and Severity Index (EASI) scores, Investigator's Global Atopic Dermatitis Assessment (IGADA) scores, and patients'/caregivers' assessment of eczema signs and symptoms. RESULTS: Overall, 49 Black/African American children aged 2-15 years with mild/moderate AD were included. At week 3, mean (SD) changes from baseline in EASI scores were -2.4 (1.7) with 1% oatmeal cream and -2.1 (2.3) with barrier cream; improvements were observed from week 1. At week 3, mean (SD) changes from baseline in IGADA scores were -0.6 (0.7) and -0.7 (0.6), respectively. Improvements in subjective ratings of signs/symptoms of eczema were observed. Both study treatments were well tolerated. CONCLUSION: OTC 1% oatmeal cream was at least as effective and safe as prescription barrier cream in this population, providing a novel, fast-acting, and cost-effective option for the symptomatic treatment of mild-to-moderate AD in Black/African American children.

Clinical and histologic findings after use of a novel combined retinol, tripeptide, and glaucine containing cream in the treatment of photo-aged skin.

BACKGROUND: Neck skin is thinner and has a more delicate dermal layer than facial skin. The studied product was specifically formulated for the neck combining a hydrating delivery system with a trifunctional corrective technology composed of 0.2% pure retinol, 2.5% tripeptide concentrate, and 5.0% glaucine complex to help improvement in signs of aging. OBJECTIVES: To evaluate cosmetic and histologic changes 3 months after treatment using immunostains for Type I collagen, Type III collagen, and glycosaminoglycan (GAGS). In addition, overall clinical improvement in photoaged skin was measured by both Griffith's photonumeric photoaging scale, photographic improvement, and questionnaires. METHODS: This study was an open-label, blinded clinical trial evaluating a combined retinol, tripeptide, and glaucine containing cream in the treatment of photo-aged skin. The study enrolled a total of 20 healthy male or female subjects, who applied the product for 3 months to their face and neck. RESULTS: Clinical as well histologic changes were consistent with improvement in all 20 subjects. CONCLUSION: Use of a combined retinol, tripeptide, and glaucine containing cream led to both clinical and histologic improvement of phototoaging.

Fixed-combination halobetasol propionate and tazarotene topical lotion decreases TNF-α and IL-17A levels in psoriatic lesions.

OBJECTIVE: Fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) is approved for the treatment of plaque psoriasis in adults, with a demonstrated efficacy and safety profile in phase 3 trials. This study examined the effect of HP/TAZ on the reduction of tumor necrosis factor alpha (TNF-α) and interleukin 17 A (IL-17A) and its correlation to psoriasis improvement. MATERIALS AND METHODS: Ten adults with mild-to-moderate plaque psoriasis and 2 symmetrical plaques self-applied HP/TAZ (treated plaque) or vehicle lotion (untreated plaque) for 12 weeks. At baseline and each study visit (weeks 2, 4, 8, and 12), Investigator's Global Assessment (IGA) score and erythema, scaling, and induration were assessed. Additionally, D-squame tape strips were utilized to quantify TNF-α and IL-17A in target lesions by enzyme-linked immunosorbent assay. RESULTS: Significant improvements in mean IGA score in HP/TAZ-treated compared with untreated plaques were evident at week 2 and maintained through week 12 (p < 0.003). HP/TAZ significantly reduced TNF-α levels at weeks 4 through 12 (p < 0.03) and IL-17A levels at weeks 2 through 8 (p < 0.05) in treated compared with untreated plaques. CONCLUSIONS: HP/TAZ was highly effective in treating psoriasis plaques and, although HP/TAZ is not a biologic, effectively reduced cytokine-associated inflammatory markers that drive psoriatic disease.

Long-Term Safety and Efficacy of Twice-Daily Topical Clascoterone Cream 1% in Patients Greater Than or Equal to 12 Years of Age With Acne Vulgaris.

BACKGROUND: Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged ≥ 12 years based on results from two 12-week Phase 3 studies in patients with moderate-to-severe acne. Safety and efficacy of clascoterone in patients aged ≥ 12 years from an open-label, long-term extension study are presented.  Methods: Enrolled patients applied clascoterone cream 1% twice daily to the entire face and, if desired by the patient and/or investigator, truncal acne, for up to 9 months. Patients achieving Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) could stop treatment and resume if/when acne worsened. Safety was assessed from treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs [telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus]) in all treated patients. Efficacy was assessed from IGA at each visit among those completing the study per-protocol (PP); face and trunk were evaluated individually.  Results: Of 600 patients aged ≥ 12 years (original randomization: 311 clascoterone, 289 vehicle), 343 completed the extension study (177 clascoterone, 166 vehicle). There were 187 TEAEs in 108/598 clascoterone-treated patients (18.1%), including 56/311 (18.0%) and 52/287 (18.1%) patients originally randomized to clascoterone and vehicle, respectively; the most common LSRs (previous clascoterone/vehicle) were erythema (face, 8.0%/7.7%) and scaling/dryness (face, 10.0%/7.3%). The percentage of PP patients with facial and truncal IGA 0/1 increased to 48.9% (156/319) and 52.4% (65/124), respectively, at study end. CONCLUSIONS: Clascoterone cream 1% maintained a favorable safety and efficacy profile for up to 12 months in patients aged ≥ 12 years. Eichenfield LF, Hebert AA, Stein Gold L, et al. Long-term safety and efficacy of twice-daily topical clascoterone cream 1% in patients ≥ 12 years of age with acne vulgaris. J Drugs Dermatol. 2023;22(8):810-816. doi:10.36849/JDD.7592.