CELL REGENERATION EFFICACY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amazentis SA
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Skin cell regeneration quantified by change in skin color measured by Chromameter (unit of measure: Individual Typological Angle; ITA°)
研究概览
简要总结
The objective of the study is to investigate the effect of one cosmetic product (exfoliator) containing Mitopure on the skin cell regeneration as well as on the skin hydration and skin barrier function in comparison to an untreated control area on the volar forearms.
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
- None
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
- •Healthy skin in the test area
- •Uniform skin color in the test area
- •Fitzpatrick I-III
- •Able to read and follow directions as outlined in the protocol
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
- •Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
- •Insulin-dependent diabetes mellitus (type 1 and 2)
- •Documented allergies to cosmetic products and/or ingredients,
- •Documented allergies to plaster systems or tape adhesives
- •Active skin disease at the test area like acute dermatitis, that requires actual topical medication on the test area and/or systemic drug treatment according to a physician
- •Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
- •All kinds of beard (except a moustache) during the whole study
- •Any topical medication at the test area within the last 3 days prior to the start of the study and throughout the entire course of the study
- •Topical medication with anti-inflammatories, antihistamines within 1 week prior to the start of the study
- •Topical medication with Immuno-suppressive medication within 2 weeks prior to the start of the study
- •Systemic (oral) medication with Antibiotic (except penicillin) or anti-inflammatory steroids within 4 weeks prior to the start of the study and throughout the entire course of the study
- •Systemic (oral) medication with anti-inflammatory non-steroids within 2 weeks prior to the start of the study and throughout the entire course of the study
- •Phototherapy within 4 weeks prior to the start of the study and throughout the entire course of the study
- •Systemic (oral) medication with retinoids within 6 months prior to the start of the study and throughout the entire course of the study
研究组 & 干预措施
Untreated, stained forearm
On day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours). The cosmetic product will not be applied for two weeks to the volar forearm test area.
干预措施: DHA stain (Other)
Untreated, stained forearm
On day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours). The cosmetic product will not be applied for two weeks to the volar forearm test area.
干预措施: No cosmetic product application - forearm (Other)
Treated, stained forearm
On day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours). The cosmetic product will then be applied twice daily for two weeks to the volar forearm test area.
干预措施: DHA stain (Other)
Treated, stained forearm
On day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours). The cosmetic product will then be applied twice daily for two weeks to the volar forearm test area.
干预措施: Cosmetic product application - forearm (Other)
Untreated, unstained forearm
On day 1, the volar forearm test area will not undergo DHA staining. The cosmetic product will not be applied for two weeks to the volar forearm test area.
干预措施: No DHA stain (Other)
Untreated, unstained forearm
On day 1, the volar forearm test area will not undergo DHA staining. The cosmetic product will not be applied for two weeks to the volar forearm test area.
干预措施: No cosmetic product application - forearm (Other)
Treated, unstained forearm
On day 1, the volar forearm test area will not undergo DHA staining. The cosmetic product will then be applied twice daily for two weeks to the volar forearm test area.
干预措施: No DHA stain (Other)
Treated, unstained forearm
On day 1, the volar forearm test area will not undergo DHA staining. The cosmetic product will then be applied twice daily for two weeks to the volar forearm test area.
干预措施: Cosmetic product application - forearm (Other)
Facial treatment
For two weeks on the face (excluding eye area), a cleansing cosmetic product containing Mitopure will be applied twice daily, and the cosmetic test product (that is used on forearms) will be applied once daily.
干预措施: Cosmetic products application - face (Other)
结局指标
主要结局
Skin cell regeneration quantified by change in skin color measured by Chromameter (unit of measure: Individual Typological Angle; ITA°)
时间窗: 14 days
Skin cell regeneration is quantified by the change in skin colour. Skin colour is measured with the Chromameter instrument (skin colour unit of measure: Individual Typological Angle \[ITA°\]). Therefore, skin cell regeneration is measured by the change in ITA°, such that a larger positive change in ITA° represents improved skin cell regeneration. Skin cell regeneration will be calculated 4, 8, 11, and 14 days after baseline.
次要结局
- Skin hydration(14 days)
- Skin barrier function(14 days)
- Product traits(14 days)