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1.
J Cosmet Laser Ther ; 25(1-4): 25-32, 2023 May 19.
Artigo em Inglês | MEDLINE | ID: mdl-37394829

RESUMO

The goal was to determine ways to optimize diagnostic and therapeutic measures for various types of melasma in the outpatient setting of the dermatovenerological ambulatory clinic. The study involved 112 women with a confirmed diagnosis of facial melasma whose disease lasted for at least 2 years. The severity of patient pigmentation was evaluated using the Melasma Area Severity Index and the Melasma Severity Scale. There was a significant increase in melanin levels across all melasma types, an increase in erythema in the dermal type, and an increase in sebum production in the epidermal type.


Assuntos
Melanose , Pele , Humanos , Feminino , Face , Epiderme , Eritema , Melanose/tratamento farmacológico , Resultado do Tratamento
2.
Viruses ; 15(9)2023 08 29.
Artigo em Inglês | MEDLINE | ID: mdl-37766235

RESUMO

We present the results of a randomized, double-blind, placebo-controlled, multi-center clinical trial phase I/II of the tolerability, safety, and immunogenicity of the inactivated whole virion concentrated purified coronavirus vaccine CoviVac in volunteers aged 18-60 and open multi-center comparative phase IIb clinical trial in volunteers aged 60 years and older. The safety of the vaccine was assessed in 400 volunteers in the 18-60 age cohort who received two doses of the vaccine (n = 300) or placebo (n = 100) and in 200 volunteers in 60+ age cohort all of whom received three doses of the vaccine. The studied vaccine has shown good tolerability and safety. No deaths, serious adverse events (AEs), or other significant AEs related to vaccination have been detected. The most common AE in vaccinated participants was pain at the injection site (p < 0.05). Immunogenicity assessment in stage 3 of Phase II was performed on 167 volunteers (122 vaccinated and 45 in Placebo Group) separately for the participants who were anti-SARS-CoV-2 nAB negative (69/122 in Vaccine Group and 28/45 in Placebo Group) or positive (53/122 in Vaccine Group and 17/45 in Placebo Group) at screening. On Day 42 after the 1st vaccination, the seroconversion rate in participants who were seronegative at screening was 86.9%, with the average geometric mean neutralizing antibody (nAB) titer of 1:20. A statistically significant (p < 0.05) increase in IFN-γ production by peptide-stimulated T-cells was observed at Days 14 and 21 after the 1st vaccination. In participants who were seropositive at screening but had nAB titers below 1:256, the rate of fourfold increase in nAB levels was 85.2%, while in the participants with nAB titers > 1:256, the rate of fourfold increase in nAB levels was below 45%; the participants who were seropositive at screening of the 2nd vaccination did not lead to a significant increase in nAB titers. In conclusion, inactivated vaccine CoviVac has shown good tolerability and safety, with over 85% NT seroconversion rates after complete vaccination course in participants who were seronegative at screening in both age groups: 18-60 and 60+. In participants who were seropositive at screening and had nAB titers below 1:256, a single vaccination led to a fourfold increase in nAB levels in 85.2% of cases. These findings indicate that CoviVac can be successfully used both for primary vaccination in a two-dose regimen and for booster vaccination as a single dose in individuals with reduced neutralizing antibody levels.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Humanos , Pessoa de Meia-Idade , Idoso , Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , Vacinas Atenuadas , Anticorpos Neutralizantes , Anticorpos Antivirais
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