NCT06723340已完成不适用
Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Photosensitization Under Normal Conditions and When Exposed to Sunlight of a Scar Gel
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Absence
研究概览
简要总结
Evaluate the potential of Primary Dermal Irritability, Accumulated Dermal Irritability, Dermal Sensitization, Photoallergy and Photosensitization, of health products through the application of Patch Test, proving the safety of the product for topical use. The study will be conducted with a Brazilian sample in which 55 research participants will be included. Depending on the results, the present study may support the claim: dermatologically tested, non-irritating, non-sensitizing, non-photoirritating and non-photosensitizing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants of both sexes aged 18 to 70 years;
- •Phototypes: I, II, III, and IV (For the phototest trial, only phototypes II and III will be considered);
- •Intact skin in the application area;
- •Willingness to follow the trial procedures and attend the center on the specified dates and times for medical evaluations and for application and reading of dressings;
- •Understanding, consent, and signing of the Informed Consent Form (ICF).
排除标准
- •Pregnancy or risk of pregnancy/lactation;
- •Use of anti-inflammatory drugs within 30 days and/or immunosuppressive drugs up to three months before selection;
- •Immunosuppression due to drugs or active diseases;
- •Uncompensated endocrinopathies;
- •Personal history of atopy;
- •Intense sun exposure or tanning sessions up to 15 days before the evaluation or during the study period;
- •Plans to bathe in the sea, pool, or sauna during the study;
- •Practice of water sports during the study;
- •Dermographism;
- •Use of oral or topical treatments with vitamin A acid and/or its derivatives up to one month before the start of the study;
- •Aesthetic and/or dermatological treatments on the body within three weeks prior to selection;
- •Scheduled vaccination during the study period or within three weeks prior to selection;
- •History of sensitization, irritation, or photosensitization to topical products;
- •Active skin conditions (local and/or widespread) that could interfere with study results;
- •Skin reactivity;
- •Use of new medications during the study;
- •Previous participation in studies with the same product;
- •Congenital or acquired immunodeficiency;
- •Clinically significant or current evidence of alcohol or drug abuse;
- •Known or suspected history of intolerance to any ingredient in the study product;
- •History of non-adherence or unwillingness to adhere to the study protocol;
- •Employees of Medcin or the sponsoring company involved in the study, or close family members of an employee involved in the study;
- •Other conditions deemed reasonable by the researcher for disqualification from study participation. If applicable, this must be noted in the clinical record.
- •Exclusion Criteria for the Phototest:
- •Previous history of conditions exacerbated or triggered by ultraviolet radiation;
- •Use of photosensitizing drugs;
- •History or presence of photodermatoses;
- •Personal or family history of skin cancer.
研究组 & 干预措施
Experimental
Experimental
Scar gel
干预措施: Scar gel (Device)
结局指标
主要结局
Absence
时间窗: 9 weeks
Absence of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Photosensitization under normal conditions and when exposed to sunlight.
次要结局
未报告次要终点
研究者
研究点 (1)
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