RBR-3nsdfy6招募中未知
Evaluation of primary irritability potential, accumulated and skin sensitization of a bandage (090997-01) in controlled and maximized conditions (RIPT) - RIPT RIPT
Kors do Brasil Produtos Paramédicos0 个研究点开始时间: 2022年1月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •Agreement to comply with safety guidelines in order to minimize the risks of contamination by COVID 19; healthy subjects; intact skin in the test region; agreement to adhere to the trial procedures and requirements and to attend the institute on the day(s) and time(s) determined for the evaluations; ability to give written consent to their participation in the study; 18 to 59 years old; phototype (Fitzpatrick): I to IV; any gender
排除标准
- •Subjects who are to the risk group for COVID 19, i.e., with diabetes; chronic cardiovascular; renal and respiratory disorders; immunosuppressed or other conditions deemed by the physician as belonging to the risk group; pregnant or lactating women; skin marks in the experimental area that interfere with the assessment of possible skin reactions (pigmentation disorders; vascular malformations; scars; increased hairiness; ephelides and nevus in large quantities; sunburn); active (local or disseminated) dermatoses that may interfere with the study results; history of allergic reactions; irritation or intense feelings of discomfort to topical products: cosmetics; health products or medicines; history of atopy (atopic dermatitis; allergic rhinitis; allergic bronchitis; allergic conjunctivitis; etc.); feeling of discomfort with temperature changes (too hot, too cold) and or when using the air conditioning; Subjects with a history of allergy to the materials used in the study; subjects with a known allergy to acrylates; history of pathologies aggravated or triggered by ultraviolet radiation; immunodeficient patients; intense sun exposure or tanning session within 15 days before the initial assessment; predicted intense sun exposure or tanning session during the study period; 11 de 23 MOD_PRO_CEP Rev. 05 All-S-RIPT-SO-PAD-090997-01-06-21-PROF-V01; prediction of bathing in the sea, swimming pool or bathtub during the study; subjects who practice water sports; dermographism; body aesthetic and or dermatological treatment within 03 weeks before enrolment; use of the following medications for topical or systemic use: immunosuppressants; antihistamines; non-hormonal anti-inflammatory drugs and corticosteroids up to 2 weeks before selection or; considering storage corticosteroids; the interval should be 1 month before enrolment; Treatment with acidic vitamin A and or its derivatives; orally or topically; within 01 month before the beginning of the study; predicted vaccination during the study or within 03 weeks before the study; participating or have participated in another clinical study completed less than 07 days before the enrolment, in case the previous study is acceptable in use; participating in or have participated in another clinical study completed less than 21 days ago; if the previous study is a compatibility study or an adverse reaction investigative study; any condition not mentioned above that; in at the investigator's opinion; may compromise the study evaluation; history of non-adherence or unwillingness to adhere to the study protocol; professionals directly involved in carrying out this protocol and their families
研究者
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