NCT04905368已完成不适用
Tolerability of a Topical Dermo-cosmetic Product in Acne-prone Subjects
Klynical Consulting & Services1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年5月12日最近更新:
适应症
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
- Signs of intolerance associated with the topical use of SS-POR11
研究概览
简要总结
The goal of the present study is to assess the safety of a topical probiotic (probiotic strain; SS-POR11) on acne prone-skin, and the impact of SS-POR11 on the distribution of porphyrins, in subjects with mild-to-moderate acne [Investigator's Global Assessment (IGA) 1-3].
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant's first language of French or English, given the written language of the ICF
- •Participants willing to sign the ICF upon entering the study
- •Participant must be willing and able (in the PI's opinion) to comply with all study requirements
- •Participant must be aged 18-40 years
- •Participant must have a screening and baseline IGA score of 1 (rare blemishes/clear skin) or 2-3 (mild to moderate facial acne vulgaris)
- •Participant must agree to appear on all evaluation days and conform to all study-related instructions
- •Participant must agree not to undergo any topical treatments in the areas under investigation during the study period
排除标准
- •Participants under the age of 18 years or over the age of 40
- •Refusal to sign the ICF
- •Participants has any injuries or tumors in the areas under investigation
- •Participant has a recent (i.e., 3 months) surgery or invasive treatment in the areas under investigation
- •Use of oral antibiotics within 4 weeks prior to start of study
- •Use of oral or topical "probiotic" products within one month prior to start of study
- •Prior (3 months) or planned use of chemical peels, microdermabrasion, microneedling, or exfoliants during the course of the study
- •Participant is using or has used within 3 months drugs such as corticosteroids, immunosuppressants, or others collagen-production inhibitors
- •Participant is pregnant or lactating or wishes to get pregnant within the next 3 months, or refuses to use appropriate contraceptive method (in case of women of childbearing potential)
- •Participant has active herpes simplex in the investigated areas or a history of herpes labialis with four or more outbreaks in the 12 months prior to baseline
- •Participant has immunocompromising diseases; any known allergy or hypersensitivity to any of the ingredients of the investigational product
- •Participants possessing any of the contraindications for use of SS-POR11
- •Participant has tattoos, piercings, excessive scarring (e.g., hypertrophic or keloid scars) in the areas under investigation
- •Current or prior (3 months) change in the use of retinoids; Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months; and any other criteria that at the discretion of the Investigator, could interfere with study assessments or expose the subject to undue risk by study participation.
结局指标
主要结局
Signs of intolerance associated with the topical use of SS-POR11
时间窗: Week 4
Frequency of signs of intolerance, via evaluation of the Skin Tolerability Test
Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11
时间窗: Week 4
Frequency of AEs and SAEs
Subject sensitivity to SS-POR11
时间窗: Baseline
Frequency of signs of sensitivity, via evaluation of the Skin Tolerability Test.
次要结局
- Porphyrin distribution(Week 2, Week 4)
- Investigator Global Assessment (IGA)(Week 2, Week 4)
研究者
研究点 (1)
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