跳至主要内容
临床试验/RBR-2bz5dm6
RBR-2bz5dm6尚未招募1 期

Evaluation of the potential for Primary and Cumulative Irritability and Skin Sensitization of a Nasal Spray (094840-01) under controlled and maximized conditions (RIPT)

Allergisa Pesquisa Dermato-Cosmetica Ltda0 个研究点开始时间: 2023年3月22日最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18Y 至 70Y(—)

入选标准

  • Agreement to comply with safety guidelines to minimize the risks of contamination with COVID-19; healthy participants; both genders; intact skin in the test region; agreement to adhere to trial procedures, scheduled visits, and requirements; ability to consent to your participation in the study in writing; age 18 to 70 years; phototype (Fitzpatrick) I to IV

排除标准

  • Participants who belong to the risk group for COVID-19 (diabetes, with chronic cardiovascular, kidney and respiratory problems, immunosuppressed or other conditions that the doctor judges as belonging to the risk group); pregnant or lactating women; skin marks in the experimental area that interfere with the evaluation of possible skin reactions (pigmentation disorders, vascular malformations, scars, increased hairiness, freckles and nevus in large numbers, sunburn); active dermatoses (local or disseminated) that may interfere with the study results; history of allergic reactions, irritation or intense feelings of discomfort to topical cosmetics, health products or medications; history of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.); discomfort with changes in temperature (too hot/too cold) and/or when using air conditioning; participants with a history of allergy to the materials used in the study; participants with known allergy to acrylates; history of pathologies aggravated or triggered by ultraviolet radiation; people with immunodeficiencies; intense sun exposure or tanning session up to 15 days before the initial assessment; prediction of intense sun exposure or tanning session during the study period; planning to take a bath in the sea, pool or bathtub during the study; participants who practice water sports; dermographism; body aesthetic and/or dermatological treatment up to 03 weeks before selection; use of the following topical or systemic medications: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs and corticosteroids up to 2 weeks before selection or, considering deposit corticosteroids, the interval should be 1 month before selection; treatment with acidic vitamin A and/or its derivatives orally or topically up to 01 month before the beginning of the study; prediction of vaccination during the study or up to 03 weeks before the study; be participating or have participated in another clinical study that ended less than 07 days before the selection, in case the previous study was acceptable in use; be participating or have participated in another clinical study that ended less than 21 days ago, if the previous study is a compatibility or investigative study of Adverse Reaction; any condition not mentioned above that, in the opinion of the investigator, may compromise the evaluation of the study; history of non-adherence or unwillingness to adhere to the study protocol; professionals directly involved in carrying out this protocol and their family members

研究者

发起方
Allergisa Pesquisa Dermato-Cosmetica Ltda

相似试验