A Study With Biophysical Methods and Skin Biopsies to Evaluate the Effect on the Skin of Healthy Volunteers of Cosmetic Creams Before and After the Use of Nd:YAG Laser
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Skin Biopsies
研究概览
简要总结
Study with biophysical methods and skin biopsies to evaluate the effect on the skin of healthy volunteers of
- cosmetic creams of Unisooth EG-28® mixture before and after Nd:YAG and
- the Unisooth EG-28® ingredient with iontophoresis and external application of cosmetic cream with active ingredient Olea vitae PLF®.
OBJECTIVE: To be investigated by approved non-invasive biophysical methods (Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. Official Journal L 066, 11/03/2003 P. 0026 - 0035), such as transdermal water loss, erythema, pigmentation, keratin hydration (MPA 5 device), elasticity (Cutometer 575 device) and skin microtopography-thin line skin surface imaging (Skin Visoscan VC 98 and Skin Visiometer) and by minimally invasive methods such as skin biopsies, the effect on the skin of substances with a) anti-inflammatory action and b) antioxidant-anti-ageing action incorporated in cosmetic products when applied alone and/or in combination with other aesthetic approved methods with or without the use of devices used in Aesthetics such as Laser Nd:YAG, or diode laser, iontophoresis.
详细描述
Background and study aims This study aims to evaluate the effects of certain cosmetic creams on the skin of healthy volunteers. Researchers will use biophysical methods and skin biopsies to assess the impact of these creams, both alone or/and in combination with laser treatments.
The study will include efficacy tests (efficacy tests-claim substantiation) with biophysical methods in healthy volunteers of the above-mentioned bioactive substances incorporated in products when applied on their skin either with topical application or in combination with the use of machinery (iontophoresis) and the comparison of results between the methods used.
Healthy male and female volunteers aged 18 to 65 years can participate in this study. Participants will apply either an active cream or a placebo cream to the inner surface of both arms twice daily (morning and evening) for a certain period. The study will measure transdermal water loss, erythema, pigmentation, and keratin hydration using the MPA 5 device before the beginning of the trial and at the end . Elasticity will be measured using the Cutometer 575 device at the same time points. Additionally, small skin biopsies will be taken before starting the cream application and after 14 days to assess collagen improvement.
The study aims to demonstrate the effectiveness of the active ingredients in the cosmetic formulations. The results will help understand how these ingredients and treatments affect the skin. While the non-invasive tests are safe, the skin biopsies are minimally invasive and carry a small risk of discomfort or minor complications.
Study was conducted at the Established Laboratory of Chemistry - Biochemistry - Cosmetology, Department of Biomedical Sciences, University of West Athens, Aegaleo Alsace Campus (Greece)
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
- Single (Participant)
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
- •Volunteer individuals aged 18 to 65 years, either sex
- •Written and informed consent
- •Healthy volunteers without skin disease or any other diseases (acute or chronic)
排除标准
- •Pregnancy, lactating, or planned pregnancy
- •People who use external application containing steroids for the treatment of skin disease more than one month
- •Participated in the same trial within six months from the interview
- •People with hypersensitive skin
- •Skin abnormalities such as severe acne, erythema, telangiectasia on the test site
- •Used the same or similar cosmetic (or pharmaceutical) on the test site within three months from the interview
- •Have peeling of skin or wrinkles removed within six months from the interview
- •Other unsuitable reasons for clinical trial based on the discretion of the investigator
研究组 & 干预措施
placebo cream
everyday using of placebo cream
干预措施: Placebo cream (Other)
active cream
everyday using of active cream
干预措施: active cream (Other)
结局指标
主要结局
Skin Biopsies
时间窗: 2 weeks
Skin puncture biopsies (2.5-3.0 mm) were taken from the forearm of each volunteer. The samples were taken before treatment (Pre-treatment) D=0 and 14 days after laser and product application (Post treatment) D= 14, to all 12 volun-teers. The skin was cleaned with a providone-iodine solution, before taking the biopsy, and the area was anesthetized with a xylocaine solution with epineph-rine. A special cylindrical tool was used, which was rotated through the skin, to remove a small part of the skin, including deeper layers. The incision depth was up to the dermis. The biopsies were placed in numbered vials with formalin so-lution and then fixed for observation under the optical microscope. The goal was to observe the possible increase in the thickness of the epidermis, or the dermis, as well as the morphological observation of the structure of the dermis, in terms of collagen and elastin fibers. The dermis' thickness was measured from the start of the dermoepidermal synapse to the end o
Trans epidermal water loss (TEWL)
时间窗: 2 weeks
Tewameter MPA-5 Courage + Khazaka electronic GmbH (Germany) was used
keratin hydration
时间窗: 2 weeks
Corneometer CM 825 Courage + Khazaka electronic GmbH (Germany) was used
melanin and skin erythema.
时间窗: 2 weeks
Mexameter MPA-5 Courage + Khazaka electronic GmbH (Germany) was used
skin elasticity
时间窗: 2 weeks
Cutometer MPA 580, Courage + Khazaka electronic GmbH (Germany) was used for skin elasticity parameters: R2: visco-elasticity in % (resistance to the mechanical force versus ability of recovery), R5: net elasticity in %: Ur/Ue = elastic part of the suction phase vs. immediate recovery during relaxation phase, R7: Ur/Uf proportion of the immediate recovery compared to the amplitude after suction in %.
次要结局
- self assesment questionnaire(2 months)
研究者
Vasiliki Gardiki
Laboratory Teaching Stuff, Phd candidate
University of West Attica