Efficacy and Safety of LetibotulinumtoxinA in the Treatment of Moderate and Severe Glabellar Lines in Females 35 to 50 Years of Age: Post Hoc Analyses of the Phase 3 Clinical Study Data.

Background: Botulinum toxin type A (BoNT-A) injections continue to be widely used as a common treatment for both males and females. According to a recent survey conducted by the International Society of Plastic Aesthetic Surgeons, the majority of patients receiving these injections are females between the ages 35 and 50.

Objectives: A post hoc analysis was conducted to examine whether there were variances in the effectiveness and safety of letibotulinumtoxinA for treating vertical glabellar lines between the broader female study population and a particularly defined group of female participants aged 35 to 50.

Immunogenicity and safety of NVX-CoV2373 as a booster: A phase 3 randomized clinical trial in adults.

Background: To combat the SARS-CoV-2 pandemic, multiple vaccines using different manufacturing platforms have been developed, including NVX-CoV2373 (an adjuvanted recombinant protein vaccine). As SARS-CoV-2 variants have emerged, some of which evade vaccine-induced immunity, introduction of vaccine booster doses has become critical. Employing different vaccine types for primary series vaccination and boosting could expand vaccine coverage and access.

Safety, Immunogenicity, and Efficacy of the NVX-CoV2373 COVID-19 Vaccine in Adolescents: A Randomized Clinical Trial.

Importance: Greater than 20% of cases and 0.4% of deaths from COVID-19 occur in children. Following demonstration of the safety and efficacy of the adjuvanted, recombinant spike protein vaccine NVX-CoV2373 in adults, the PREVENT-19 trial immediately expanded to adolescents.

Safety, Immunogenicity and Efficacy of NVX-CoV2373 in Adolescents in PREVENT-19: A Randomized, Phase 3 Trial.

Background: Over 20% of cases and 0.4% of deaths from Covid-19 occur in children. Following demonstration of safety and efficacy of the adjuvanted, recombinant spike protein vaccine NVX-CoV2373 in adults, the PREVENT-19 trial enrolled adolescents.

Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico.

Background: NVX-CoV2373 is an adjuvanted, recombinant spike protein nanoparticle vaccine that was shown to have clinical efficacy for the prevention of coronavirus disease 2019 (Covid-19) in phase 2b-3 trials in the United Kingdom and South Africa, but its efficacy had not yet been tested in North America.

Methods: We conducted a phase 3, randomized, observer-blinded, placebo-controlled trial in the United States and Mexico during the first half of 2021 to evaluate the efficacy and safety of NVX-CoV2373 in adults (≥18 years of age) who had not had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Participants were randomly assigned in a 2:1 ratio to receive two doses of NVX-CoV2373 or placebo 21 days apart.

The Second of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.

Background: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum.

Objectives: The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines.

Methods: This was a multicenter, open-label, repeat-dose, 1-year phase II safety study.

Calcium Hydroxylapatite Dermal Filler for Treatment of Dorsal Hand Volume Loss: Results From a 12-Month, Multicenter, Randomized, Blinded Trial.

Background: Calcium hydroxylapatite (CaHA) microspheres suspended in a carrier gel is an opaque dermal filler that has been used to provide immediate volume correction in the dorsal hands.

Objective: To assess the safety and effectiveness of CaHA for the correction of volume loss in the hands up to 12 months.

Materials And Methods: This multicenter, controlled, single-blind study (NCT01832090) included 114 subjects randomized 3:1 to CaHA treatment and untreated control groups.

The efficacy assessment of a self-administered immunotherapy protocol.

Background: We previously reported the safety of a self-administered subcutaneous immunotherapy (SCIT) protocol. Here we report the results of the retrospective efficacy trial of the United Allergy Service (UAS) self-administered SCIT protocol. We hypothesized that by utilizing a slow SCIT buildup phase, designed to attain recommended allergen concentrations on a cumulative basis, efficacious outcomes and clinical relevance would be achieved.

Efficacy and safety of once-daily luliconazole 1% cream in patients ≥12 years of age with interdigital tinea pedis: a phase 3, randomized, double-blind,vehicle-controlled study.

Background: Interdigital tinea pedis is one of the most common clinical presentations of dermatophytosis.

Objective: This phase 3 study evaluated the safety and efficacy of luliconazole cream 1% in patients with tinea pedis.

Methods: A total of 321 male and female patients aged ≥12 years with tinea pedis and eligible for modified intent-to-treat analysis were randomized 1:1 to receive luliconazole cream 1% (n=159) or vehicle (n=162) once daily for 14 days.

Lidocaine/tetracaine peel in topical anesthesia prior to laser-assisted hair removal: Phase-II and Phase-III study results.

Background: Patient comfort is essential during dermatologic procedures.

Objectives: To evaluate anesthetic efficacy in laser-assisted hair removal of a self-occluding topical anesthetic (lidocaine 70 mg/g and tetracaine 70 mg/g, "LT peel"), which air-dries and can be peeled off 30 min post-application.

Methods: Studies A (Phase-II) and B (Phase-III) were randomized, double-blind, placebo-controlled and paired.