NCT05300542已完成不适用
Efficacy Study of a Novel Cosmetic Product to Reduce an UVB Induced Erythema
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amazentis SA
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Erythema (skin redness) assessed by Chromameter
研究概览
简要总结
The aim of this study is to determine the erythema-reducing efficacy of a test product in two concentrations on a light sunburn induced by a sun simulator compared to an untreated control and a placebo product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written Informed Consent to participate in the study
- •Willingness to actively participate in the study and to come to the scheduled visits
- •Female and/or male
- •From 18 to 65 years of age
- •Uniform skin color and no erythema or dark pigmentation in the test area
- •ITA° > 28 in the test area
排除标准
- •Female subjects: Pregnancy or lactation
- •Drug addicts, alcoholics
- •AIDS, HIV-positive or infectious hepatitis
- •Conditions which exclude a participation or might influence the test reaction/evaluation
- •Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
- •One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases
- •Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
- •Insulin-dependent diabetes mellitus
- •Electronic implant (e.g. pace maker, insulin pump, hearing aid, and the like) that cannot be removed during irradiation
- •Documented allergies to cosmetic products and/or ingredients
- •Active skin disease at the test area
- •Irregularly tanned skin in the test area
- •Medical history of dysplastic nevi, melanoma or other skin carcinoma
- •Medical history of abnormal response to sunlight
- •Regular use of tanning beds (more than 10 times within the last 6 months)
- •Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
- •Usage of medication with known photo-toxic and/or photo-sensitizing potential (e.g. some antibiotics, blood pressure regulating agents and antidepressants agents; hypericum perforatum) within the last 14 days prior to the start of the study and/or throughout the entire course of the study
- •Any topical medication at the test area within the last 7 days prior to the start of the study and/or throughout the entire course of the study
- •Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study and/or throughout the entire course of the study
- •Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study and/or throughout the entire course of the study
研究组 & 干预措施
Skin UVB irradiated 1.25MED
Experimental
干预措施: Topical Placebo Cream (Other)
Skin UVB irradiated 1.25MED
Experimental
干预措施: Topical Cream with 0.5% Active (Other)
Skin UVB irradiated 1.25MED
Experimental
干预措施: Topical Cream with 1% Active (Other)
Skin UVB irradiated 1.6MED
Experimental
干预措施: Topical Placebo Cream (Other)
Skin UVB irradiated 1.6MED
Experimental
干预措施: Topical Cream with 0.5% Active (Other)
Skin UVB irradiated 1.6MED
Experimental
干预措施: Topical Cream with 1% Active (Other)
Untreated Skin
No Intervention
结局指标
主要结局
Erythema (skin redness) assessed by Chromameter
时间窗: 3 days
Visual erythema evaluation by a trained grader on a scale of -2 (marked redness) to 3 (no redness)
时间窗: 3 days
次要结局
未报告次要终点
研究者
研究点 (1)
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