J Drugs Dermatol
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Multicenter Study
Hispanic Tattoo Artists Could Provide Skin Cancer Prevention via Aftercare Instructions and Social Media
The incidence of melanoma and non-melanoma skin cancer in the Hispanic population has increased. Hispanics are more likely to present with advance-staged melanoma and worse overall prognosis. Thus, public health campaigns are necessary to target the underrepresented Hispanic population. ⋯ Hispanic tattoo artists could serve as public health allies and influence early detection of skin cancers in the Hispanic population by implementing preventative skin cancer behaviors in their daily work routines and providing comprehensive sun safety information through aftercare instructions and social media. J Drugs Dermatol. 2019;18(12):1237-1243.
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Randomized Controlled Trial Multicenter Study
Efficacy, Safety, and Tolerability of a Halobetasol 0.01% /Tazarotene 0.045% Fixed Combination in the Treatment of Severe Localized Plaque Psoriasis: Post Hoc Analysis of Two Phase III Randomized Controlled Trials
Background: The use of topical therapy is a key component in the management of almost all psoriasis patients. Topicals are considered first-line therapy for mild disease and are having an increasing role in moderate or severe psoriasis as an integral part of combination therapy. Halobetasol has been shown be effective in moderate or severe localized plaque psoriasis, and tazarotene affords important effects on epidermal hyperproliferation that may be important in more severe disease. Objective: To investigate the efficacy, safety and tolerability of a once-daily application of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion in comparison with its vehicle in patients with severe localized plaque psoriasis (as defined by an Investigator Global Assessment (IGA) of 4 and Body Surface Area (BSA) of 3%-12%. Methods: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies. ⋯ By week 8, almost half of the patients treated with HP/TAZ lotion achieved a clinically meaningful response (IGAxBSA-75) and a 52.9% reduction in mean IGAxBSA score compared with a 17.5% increase in those patients treated with vehicle (P<0.001). One patient (2.6%) treated with HP/TAZ lotion discontinued due to AE. Most frequently reported treatment related AEs were application site pain (7.9%), contact dermatitis (5.3%) and pruritus (5.3%). Conclusions: HP/TAZ lotion provides significantly greater efficacy than vehicle that is both rapid and sustained, in patients with severe localized plaque psoriasis, with good tolerability and safety over 8 weeks’ once-daily use. J Drugs Dermatol. 2019;18(10):1012-1018.
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Randomized Controlled Trial Multicenter Study
Halobetasol 0.01% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis of the Lower Extremities
Background: Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Topical corticosteroids (TCS) are the mainstay of treatment. Long-term safety remains a concern, limiting use, and posttreatment flare is common. ⋯ Quality of Life (QoL) was assessed using the Dermatology Life Quality Index (DLQI) at baseline, week 4, 8, and 12. Results: At the end of the 8-week treatment period, more than half of subjects had achieved treatment success, with 52.1%, 55.5%, and 58.2% of subjects achieving at least a 2-grade reduction in erythema, plaque elevation and scaling severity on the leg, compared with 15.7% and 22.9%, and 22.2% of those treated with vehicle (P<0.001). In addition, overall treatment success (IGA) was achieved in 37.1% of these subjects who had been treated with HP 0.01% lotion compared with 8.4% treated with vehicle (P<0.001); with a corresponding 34.2% reduction in baseline BSA and 50.5% change in mean baseline IGAxBSA (both P<0.001 versus vehicle). Overall, a clinically relevant improvement in QoL was achieved by week 4; by week 8 37.7% of subjects where the leg was the target lesion had a clinically meaningful improvement in disease severity (IGAxBSA-75). Conclusions: In conclusion, halobetasol propionate 0.01% lotion provides statistically significant efficacy following 8 weeks’ therapy compared with vehicle in subjects where the leg was identified as the target lesion, with clinically relevant improvements in QoL and more than a third of subjects achieving a clinically meaningful result. J Drugs Dermatol. 2019;18(10):1029-1036.
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Randomized Controlled Trial Multicenter Study
Efficacy of Dupilumab in Different Racial Subgroups of Adults With Moderate-to-Severe Atopic Dermatitis in Three Randomized, Placebo-Controlled Phase 3 Trials
Dupilumab, a monoclonal antibody that blocks the shared receptor subunit for interleukin (IL)-4 and IL-13, is currently approved for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis (AD). The efficacy and safety of dupilumab for AD among racial subgroups is unknown. This post hoc analysis from three phase 3 trials assessed the efficacy and safety of dupilumab vs placebo by racial subgroup (White, Asian, Black/African American). ⋯ In the three trials, dupilumab significantly (P<0.0001) improved all assessed outcomes compared with placebo in the White and Asian subgroups. In the smaller Black/African American subgroup, dupilumab significantly (P<0.0001) improved EASI endpoints and mean changes in Peak Pruritus NRS and DLQI vs placebo, with positive numeric trends favoring dupilumab in all other endpoints. Dupilumab was generally well tolerated, with an acceptable safety profile in all racial subgroups. Serious adverse events occurred more frequently with placebo; treatment discontinuations due to adverse events were rare in all treatment groups. Significant clinical improvement and a favorable benefit-risk profile can be achieved with dupilumab treatment in patients of White, Asian, and Black/African American racial subgroups with moderate-to-severe AD inadequately controlled with topical medications. ClinicalTrials.gov identifiers: NCT02277743, NCT02277769, NCT02260986
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Randomized Controlled Trial Multicenter Study
Effective and Safe Repeated Full-Face Treatments With AbobotulinumtoxinA, Hyaluronic Acid Filler, and Skin Boosting Hyaluronic Acid
Background: It is important to study full-face aesthetic combination treatments to establish well-founded individual treatment plans. Objective: To evaluate clinical outcome and perception of treatment with either abobotulinumtoxinA (ABO) or hyaluronic acid (HA) filler followed by repeated combined treatment with ABO, HA filler, and Restylane® Skinboosters (RSB). Methods & Materials: This study was conducted at four sites in Sweden, France, and Brazil and included subjects aged 35-50 years with mild/moderate nasolabial folds and moderate/severe upper facial lines. Monotherapy was ≤125 s. U ABO in at least two upper facial indications with optional touch-up or ≤1 mL HA filler in nasolabial folds/cheeks. ⋯ Treatment of several indications was well tolerated. Conclusion: Aesthetic improvement and subject satisfaction was high and increased with each treatment. All treatments were well tolerated. These data may be used as support when establishing individual treatment plans. J Drugs Dermatol. 2019;18(7):682-689.