Application of the new topical product on the diseased skin should be preceded by its safety evaluation on the healthy skin in human volunteers. We propose here guidelines for the evaluation of the irritation, sensitization, phototoxicity and photoallergy potentials for topical products. The methods for evaluation of percutaneous absorption are also discussed. The studies presented here are not the object of any regulations. Therefore, we propose here an approach for the safety evaluation of topical products in human volunteers.

Download full-text PDF

Source

Publication Analysis

Top Keywords

safety evaluation
8
human volunteers
8
topical products
8
[clinical trials
4
trials dermatology
4
dermatology phase
4
phase trials]
4
trials] application
4
application topical
4
topical product
4

Similar Publications

Glioblastoma (GBM) is a malignant tumor with highly heterogeneous and invasive characteristics leading to a poor prognosis. The CD44 molecule, which is highly expressed in GBM, has emerged as a highly sought-after biological marker. Therapeutic strategies targeting the cell membrane protein CD44 have emerged, demonstrating novel therapeutic potential.

View Article and Find Full Text PDF

Background: Comorbidity indices are used to help to estimate patients' length of hospital stay, care costs, outcomes, and mortality. Increasingly, they are considered in reimbursement models. The applicability of comorbidity indices to patients undergoing orthopaedic oncology surgery has not been studied.

View Article and Find Full Text PDF

Safety of two-dose schedule of COVID-19 adsorbed inactivated vaccine (CoronaVac; Sinovac/Butantan) and heterologous additional doses of mRNA BNT162b2 (Pfizer/BioNTech) in immunocompromised and immunocompetent individuals.

Rev Inst Med Trop Sao Paulo

January 2025

Universidade de São Paulo, Faculdade de Medicina, Hospital das Clínicas, Divisão de Clínica de Moléstias Infecciosas e Parasitárias, Laboratório de Investigação Médica em Imunologia (LIM-48), SSão Paulo, São Paulo, Brazil.

Immunocompromised individuals were considered high-risk for severe disease due to SARS COV-2 infection. This study aimed to describe the safety of two doses of COVID-19 adsorbed inactivated vaccine (CoronaVac; Sinovac/Butantan), followed by additional doses of mRNA BNT162b2 (Pfizer/BioNTech) in immunocompromised (IC) adults, compared to immunocompetent/healthy (H) individuals. This phase 4, multicenter, open label study included solid organ transplant and hematopoietic stem cell transplant recipients, cancer patients and people with inborn errors of immunity with defects in antibody production, rheumatic, end-stage chronic kidney or liver disease, who were enrolled in the IC group.

View Article and Find Full Text PDF

Sodium-glucose co-transporter 2 inhibitors, such as enavogliflozin, offer promising metabolic benefits for patients with type 2 diabetes (T2D), including glycemic control and improved cardiac function. Despite the clinical evidence, real-world evidence is needed to validate their safety and effectiveness. This study aims to evaluate the effects of weight loss and safety of enavogliflozin administration in patients with T2D in a real-world clinical setting over 24 weeks.

View Article and Find Full Text PDF

Background: Risk factors and comorbidities can complicate management of non-valvular atrial fibrillation. We describe and compare real-world safety and effectiveness of direct oral anticoagulants (DOACs; apixaban, rivaroxaban, dabigatran) and vitamin K antagonists (VKAs) in subgroups of patients with non-valvular atrial fibrillation at high risk for gastrointestinal (GI) bleeding, utilizing data from a national quasi-exhaustive French database.

Methods: Anticoagulant-naïve adults with non-valvular atrial fibrillation with ≥1 gastrointestinal bleeding risk factor, initiating anticoagulant treatment January 2016-December 2019, and covered by the French national health data system were eligible.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!