SAFETY HUMAN IN USE TEST UNDER GYNECOLOGICAL CONTROL FOR THE APPRECIATION OF SKIN ACCEPTABILITY OF THE PRODUCT GINPI REF. GINPI BATCH: 10/06/2024 IN HEALTHY FEMALE ADULT VOLUNTEERS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Efficacy evaluation (volunteer)
研究概览
简要总结
The main objective of this study was to confirm skin acceptability of the product GINPI REF. GINPI BATCH: 10/06/2024 applied under normal use conditions in healthy female adult volunteers, under gynecological control, by means of the evaluation of organoleptic characteristics and subjective efficacy of the study product by the volunteers.
Other (secondary) objective was the assessment of unexpected adverse events referred by the volunteers as well as possible reactions observed by the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women
- •Age between 18 and 65 years
- •Volunteers with sensitive skin (50%) and normal skin (50%)
- •Volunteers with Fitzpatrick skin photo-type I to IV
- •Adequate cultural level and understanding of the clinical study
- •To agree to participate voluntarily in the study and grant written Informed Consent.
排除标准
- •Volunteers with chronic or acute disease at study initiation or in the last 3 weeks prior to inclusion
- •Volunteers with skin pathologies in the last 3 weeks prior to study initiation.
- •Volunteers under pharmacological treatment.
- •Pregnant or breast-feeding women.
- •Volunteers with allergy to any of the study product components.
- •Vaccinated in the last 3 weeks previous to study start.
研究组 & 干预措施
GYNED Depigmenting
干预措施: Depigmentig cosmetic product (Other)
结局指标
主要结局
Efficacy evaluation (volunteer)
时间窗: 21 days (end of study)
Evaluation of the soothing and moisturizing of the cosmetic product by the volunteers by means of a 4 point questionnaire (4 = Fully Agree / 1= Strongly Dissagre).
Organoleptic properties evaluation (volunteer)
时间窗: 21 days (end of study)
Evaluation of the opinion of the appearance by means of a 4 point questionnaire (4 = I like it a lot / 1= I don't like it at all).
次要结局
- OBJECTIVE Safety Assessment (Adverse reactions recording)(21 days (end of study))
- SUBJECTIVE Safety Assessment (Adverse reactions recording)(21 days (end of study))