RBR-3hnmbdt尚未招募Unknown
Assessment of primary and cumulative irritation potential and sensitization potential from the skin supervised by a dermatologist to the investigational products lotion revitalizing and restorative lotion
Kosmoscience Ciência e Tecnologia Cosm Imp Exp Ltda0 个研究点开始时间: 2023年5月2日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 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
- •Healthy research participant; age range between 18 and 70 years; both sexes; phototype (Fitzpatrick): I to IV; agree to adhere to the requirements of the study in combating the COVID-19 pandemic, through preventive measures: use a mask as recommended by the WHO; use the mask while traveling to the research center and during study procedures; maintain social distancing; frequently wash your hands with soap and/or alcohol gel and attend the research center only at scheduled times to avoid crowds; agreement not to wet the site during the entire test period; understand the test procedures and agree to adhere to the study requirements; absence of inflammatory dermatoses or tattooing at the application site; signature of the Free and Informed Consent Term (TCLE)
排除标准
- •Gestation; lactation; participants who have hyperthermia (body temperature greater than or equal to 37.5°C); participants who have been diagnosed with COVID-19 by RT-PCR test or by the presence of IgM antibodies in the serology test, in the last 4 weeks or who are showing the following symptoms: dry or productive cough, sneezing, runny nose, body pain , headache, anosmia (loss of smell), ageusia (loss of taste) and/or any other symptom that may be related to covid-19 at the discretion of the investigator; participant who belongs to the risk group for COVID-19, that is, with chronic cardiovascular, renal and respiratory problems, immunosuppression or other conditions that the doctor judges as belonging to the risk group; participants with heart diseases (for example, but not limited to: atrial fibrillation, obstructive coronary artery disease); participants with kidney and/or neurological diseases; participants with severe or decompensated pulmonary and/or respiratory diseases; use of corticoids, antihistamines and/or anti-inflammatories; presence of localized or generalized dermatological diseases; presence of active inflammatory dermatoses in the test region; frequent exposure to the sun or tanning beds; having participated in an allergenicity study within a period of less than four weeks from the start of the study; research participants with a history of allergy to the material used in the study; history of atopy; history of pathologies aggravated or triggered by ultraviolet radiation; people with immunodeficiencies; prediction of intense sun exposure or tanning session during the study period; plan to take a bath in the sea, pool or sauna during the study; research participants who practice water sports; survey participants with dermographism; use of the following topical or systemic medications: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs, and corticoids up to 2 weeks before selection; vitamin A acid treatment and/or its derivatives orally or topically up to 01 month before the beginning of the study; body aesthetic and/or dermatological treatment up to 03 weeks before selection; prediction of vaccination during the study or up to 03 weeks before the study; 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 families; currently participating in another study; any condition that, in the opinion of the researcher, could compromise the study
研究者
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