Validation of Skin Instrumentation to Detect Ceramide-Driven Lipid Replenishment - Assessing Skin Glow, Hydration, Trans Epidermal Water Loss, Skin Surface Assessment, Sebum and Least-Reflection Factor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To observe the effects of ceramide-containing moisturizer versus water application on skin parameters.
研究概览
简要总结
This is a single-center, open-label, split-face, site-randomized validation study, NB250045-NB-V designed to establish and confirm the reliability, reproducibility, and sensitivity of various skin measurement methods. Evaluator blinding will be implemented to minimize observer bias.
详细描述
Each subject will serve as their own control, with right side of the face receiving the ceramide-containing moisturizer and the left side receiving water application as the control. This split-face approach reduces inter-subject variability and enables direct intra-individual comparison of the measurement methods across treated and control sites.
The study involves a single on-site visit for each subject.
- Baseline (pre-application): Subjects will undergo acclimatization in a controlled environment, after which baseline assessments will be performed for skin parameters on both test and control sites.
- Application phase: The ceramide-containing moisturizer and water control will be applied to the randomized sites under investigator supervision.
- Post-application assessments: Instrumental evaluations will be done at T15 mins following product application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1) Age: 18 to 55 years old (both inclusive) at the time of consent. 2) Sex: Healthy male and non-pregnant/non-lactating females. 3) Subject having normal, dry and sensitive skin. 4) Females of childbearing potential must have a self-reported negative pregnancy test.
- •5) Subject are generally in good health. 6) Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
- •7) If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
- •8) Subjects are willing to give written informed consent and are willing to come for regular follow up.
- •9) Subjects who commit not to use any other skincare products for the entire duration of the study.
- •10) Subject who has not participated in a similar investigation in the past three months.
- •11) Willing to use test product throughout the study period.
排除标准
- •1) History of any dermatological condition of the skin diseases. 2) Subject with present condition of allergic response to any cosmetic product. 3) Subject having allergic response to the ink. 4) Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
- •5) Subjects who have applied topical treatment for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
- •6) History of alcohol or drug addiction. 7) Subjects using other marketed products during the study period. 8) Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.
- •9) Pregnant or breastfeeding or planning to become pregnant during the study period.
- •10) History of chronic illness which may influence the cutaneous state. 11) Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.
研究组 & 干预措施
Arm 2 - Water Control Group
Water will be applied to the specified, evaluated site.
Arm 1 - Test Product . Subjects will receive the test product.
The test cream will be applied topically to the designated treatment area. A sufficient quantity of the cream will be gently massaged into the skin using light circular motions until complete absorption. Participants were instructed to apply the product to clean, dry skin and to avoid washing the treated area for a minimum period following application to allow adequate penetration. The application procedure was standardized across all subjects and was continued consistently throughout the study duration as per the protocol.
干预措施: Marketed Product - CeraVe Moisturizer (Other)
结局指标
主要结局
To observe the effects of ceramide-containing moisturizer versus water application on skin parameters.
时间窗: Change in the parameters at baseline (before application) and at post-application at T15 mins following application of the ceramide-containing moisturizer and water control.
Change in Skin Glow and least reflection factor - assessed by Skin Glossymeter GL 200
To observe the effects of ceramide-containing moisturizer versus water application on skin parameters.
时间窗: Change in the parameters at baseline (before application) and at post-application at T15 mins following application of the ceramide-containing moisturizer and water control
Change in Skin Scaliness assessed by VisioScan® VC 20 Plus
To observe the effects of ceramide-containing moisturizer versus water application on skin parameters
时间窗: Change in the parameters at baseline (before application) and at post-application at T15 mins following application of the ceramide-containing moisturizer and water control
Change in Sebum Level assessed by Sebumeter SM 825
次要结局
未报告次要终点