Clinical Evaluation of Dermal Acceptability and the Comedogenic and Acnegenic Potential of a Cosmetic Product
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Dermatological Safety and Skin Tolerability
研究概览
简要总结
This is a single-center, single-blind clinical study designed to evaluate the dermatological safety of a cosmetic product and to demonstrate the absence of comedogenic and acnegenic potential.
A total of 33 female participants, aged 18 to 60 years, with oily and acne-prone skin will be enrolled. Participants will use the investigational product for 28 days under normal conditions of use.
Dermatological safety, skin tolerability, and the absence of comedogenic and acnegenic effects will be assessed throughout the study period by clinical evaluations conducted according to the study protocol.
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
盲法说明
Participants are blinded to the identity, brand name, and commercial information of the study product. The product is applied without disclosure of its name or manufacturer to the participants.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participants aged 18 to 45 years.
- •Participants with oily and acne-prone skin.
- •Intact skin in the area intended for application and assessment of the investigational product.
- •Willingness to comply with all study procedures and attend scheduled visits and assessments.
- •Ability to understand the study requirements, provide written informed consent, and sign the Informed Consent Form (ICF).
排除标准
- •Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study.
- •Use of anti-inflammatory, immunosuppressive, or antihistamine medications within 3 weeks prior to screening.
- •Skin conditions or marks in the study area that may interfere with the evaluation of skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
- •History of atopic conditions or allergy to cosmetic products.
- •Active skin diseases and/or lesions in the assessment area or elsewhere on the body.
- •Immunosuppression due to medication use or active disease.
- •Uncontrolled endocrine disorders.
- •Relevant medical history or current evidence of alcohol or substance abuse.
- •Known history or suspected intolerance to products of the same category as the investigational product.
- •Intense sun exposure within 15 days prior to assessment.
- •Aesthetic or dermatological treatments within 4 weeks prior to assessment.
- •Any other condition that, in the investigator's opinion, may interfere with study participation, study evaluations, or justify exclusion from the study.
研究组 & 干预措施
Cosmetic Product Group
Female participants aged 18 to 60 years with oily and acne-prone skin will use the investigational cosmetic product for 28 days. Dermatological safety, skin tolerability, and the absence of comedogenic and acnegenic potential will be evaluated throughout the study period.
干预措施: Blancy Pro (Other)
结局指标
主要结局
Dermatological Safety and Skin Tolerability
时间窗: Day 28
Evaluation of the absence of skin irritation risk and assessment of participant-reported discomfort sensations under real-world conditions of use through dermatological clinical evaluations in female participants with oily and acne-prone skin.
次要结局
- Absence of Comedogenic and Acnegenic Potential(Baseline (Day 0) to Day 28)