A Proof of Concept (POC) Clinical Study to Evaluate the Appearance of Fine Lines and Wrinkles on a Developmental Cosmetic Moisturising Cream in Healthy Subjects Presenting Visible Signs of Ageing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated Versus (vs.) Untreated Side at Day 29
研究概览
简要总结
The objective of this POC clinical study is to evaluate the moisturising effects on fine lines and wrinkles, texture, barrier function, hydration and elasticity delivered by 4 weeks of twice daily application of the test product on participants presenting visible signs of ageing.
详细描述
Participants who meet all the inclusion/exclusion criteria will be randomised to one of three treatment groups: test product/positive control, test product/no treatment or positive control/no treatment at the baseline visit. Product application within treatment group will be further randomised to either the right or left side of the face. Participants will apply one of the assigned treatments to one side of the face (left or right) and another assigned treatment to the other side of the face as per the randomisation schedule. Participants will be instructed to apply the assigned treatments twice daily (morning and evening, approximately 8-12 hours apart) for 4 weeks (28 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- •Good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant and relevant abnormalities in medical history or upon physical examination
- •Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal agent [foam, gel, film, cream, suppository]) OR male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that participant
- •Willingness to actively participate in the study and to attend all scheduled visits
- •Fitzpatrick phototype I-IV
- •Visual Clinical Fitzpatrick Wrinkle Score 3- 6 in the eye (crow's feet) area on both sides of the face at screening and baseline
- •Subjects with self-reported sensitive skin
排除标准
- •Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- •Women who are breast-feeding
- •Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g.diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluations
- •Change in contraception within the last 3 months
- •Presence of open sores, pimples, cysts, irritated skin, hairs or tattoos at the application site
- •Active dermatosis (local or disseminated) that might interfere with the results of the study
- •Considered immune compromised
- •Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk
- •Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before screening visit
- •Intention of using any oral or topical steroids
- •Regular use of inhaled steroids (occasional use is permitted)
- •Regular use of topical anti-itch medications (occasional use permitted; the product should be applied with an applicator but not to the proposed application areas
- •Use of any topical drug or medication in the proposed application areas
- •Intention of being vaccinated during the study period or has been vaccinated within 3 weeks of the screening visit
- •Currently receiving allergy injections, or received an allergy injection within 7 days prior to Visit 1, or expects to begin injections during study participation
- •Blepharitis, conjunctivitis, uveitis
- •Topical ocular treatment within the last month
- •Aesthetic, cosmetic or dermatological treatment on the face within the last 3 months
- •Intense sun exposure, Ultra Violet-treatments or tanning salon visit within the last 2 weeks
- •Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- •Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 14 days of the screening visit
- •Previous participation in this study
- •Recent history (within the last 5 years) of alcohol or other substance abuse
- •An employee of the sponsor or the study site or members of their immediate family
研究组 & 干预措施
Positive control /No treatment
Participants randomized to this arm will apply Positive product at allocated sites and leave other sites untreated.
干预措施: No treatment (Other)
Test product/ No treatment
Participants randomized to this arm will apply Test product at allocated sites and leave other sites untreated.
干预措施: No treatment (Other)
Test product/ No treatment
Participants randomized to this arm will apply Test product at allocated sites and leave other sites untreated.
干预措施: Test product (Moisturising cream) (Other)
Test product/ Positive control
Participants randomized to this arm will apply Test and positive product at allocated sites.
干预措施: Test product (Moisturising cream) (Other)
Test product/ Positive control
Participants randomized to this arm will apply Test and positive product at allocated sites.
干预措施: Positive control (Commercial market place moisturising cream) (Other)
Positive control /No treatment
Participants randomized to this arm will apply Positive product at allocated sites and leave other sites untreated.
干预措施: Positive control (Commercial market place moisturising cream) (Other)
结局指标
主要结局
Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated Versus (vs.) Untreated Side at Day 29
时间窗: At Baseline and Day 29
Using fringe projection and optical triangulation techniques, the 3D (three dimensional) surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Ra is usually used for wrinkle assessments, representing the finer skin structure (Ra). Ra was the average deviation of the profile from the mean line (arithmetic mean of the absolute values of the point's heights).
次要结局
- Change From Baseline in Instrumental Cutometer Parameters R5, at Day 15 and 29(At Baseline, Day 15 and 29)
- Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated vs. Untreated Side at Day 15(At Baseline and Day 15)
- Change From Baseline in Instrumental Cutometer Parameter R7, at Day 15 and 29(At Baseline, Day 15 and 29)
- Change From Baseline in Ra (a dermaTOP Parameter), of Positive Control Treated vs. Untreated Side at Day 15 and 29(At Baseline, Day 15 and 29)
- Change From Baseline in Rz (a dermaTOP Parameter) at Day 15 and 29(At Baseline, Day 15 and 29)
- Change From Baseline in Sa (dermaTOP Parameters) at Day 15 and 29(At Baseline, Day 15 and 29)
- Change From Baseline in Stm (dermaTOP Parameters), at Day 15 and 29(At Baseline, Day 15 and 29)
- Change From Baseline in Clinical Fitzpatrick Wrinkle Score, at Day 15 and 29(At Baseline, Day 15 and 29)
- Change From Baseline in Instrumental Corneometer Values, at Day 15 and 29(At Baseline, Day 15 and 29)
- Percent Improvement From Baseline in Skin Texture Rankings Based on Lay Grader Assessment of High Resolution Images at Day 29(At Baseline and Day 29)
- Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Day 15 and 29(At Baseline, Day 15 and 29)