NCT05646953已完成不适用
A Proof-of-Concept, Safety and Efficacy Study of Vasu Facial Beauty Oil in Healthy Adult Human Subjects
NovoBliss Research Pvt Ltd2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年1月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Assessment of Reduction in Facial Wrinkles and Fine lines of Crow's feet area
研究概览
简要总结
This is an open-label, single-arm, single-center, proof-of-concept, exploratory, safety and efficacy, clinical study of a Vasu Facial Beauty Oil in healthy adult human subjects.
Considering the proof of concept study, a sufficient number [maximum of 32 subjects (25 females and 7 males)] of adult subjects will be recruited/enrolled to ensure a total of 30 subjects complete the study.
The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. The total clinical study duration is 60 Days from Day 01.
详细描述
This is an open-label, single-arm, single-center, proof-of-concept, exploratory, safety and efficacy, clinical study of a Vasu Facial Beauty Oil in healthy adult human subjects.
Considering proof of concept study, a sufficient number [maximum of 32 subjects (25 females and 7 males)] of adult subjects will be recruited/enrolled to ensure a total of 30 subjects complete the study.
The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. The adult female/male subjects will be instructed to visit the facility as per the below visits.
- Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluations
- Visit 02 (Day 30 i.e. week 4): Treatment Period, Evaluations
- Visit 03 (Day 60 i.e. week 8): Evaluations, End of Study Visit Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called on the telephone by the recruiting department prior to the enrolment visit. Subjects will be told during screening (prior to enrolment) not to wear any facial make-up or use any hair product on the study visit day.
Assessment of efficacy parameters before test product usage will be done on day 1, and after test, product usage will be done on day 30, and day 60 as listed below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 25 to 55 years (both inclusive) at the time of consent.
- •Sex: Healthy males and non-pregnant/non-lactating females.
- •Females of childbearing potential must have a self-reported negative pregnancy test.
- •Subjects are generally in good health.
- •Subject has a score of at least "mild skin aging" based on Physican Global Assessment (PGA) at screening visit.
- •Subject with Glogau Skin Age II or III as assessed by the Dermatologist/Dermatologist Trained Evaluator.
- •Subjects with wrinkles at Crow's feet area.
- •Subjects with uneven texture skin, uneven skin tone, with dry to normal skin only.
- •Subjects with dry skin having ≤ 40% value as evaluated by MoisturemeterEpiD.
- •Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
- •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.
- •Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
- •Subject is able to forgo changes in baseline medications and nutritional supplements during the study period.
- •If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (Intrauterine Device, 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.
- •If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
- •Subjects are willing not to introduce any new soaps, cleansers, laundry detergents, lotions, creams, shampoos etc. for the duration of the study.
- •Subjects are willing to give written informed consent and are willing to follow the study procedure.
- •Subjects who have used other marketed products for hair thinning in the past.
- •Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-thinning agents) or any other hair growth, treatment for thin hair, or hair products other than the test product for the entire duration of the study.
- •Willing to use test product throughout the study period.
排除标准
- •Subject has a history of allergy or sensitivity to the test treatment ingredients like Kumkumadi tailam, avocado, argan, lavender, rapeseed oil and others etc.
- •Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
- •Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
- •Subject is not willing to avoid the unprotected sun or other UV radiation exposure during the study period.
- •Subject is currently pregnant/breastfeeding.
- •Subject has a history of alcohol or drug addiction.
- •Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.
- •Pregnant or breastfeeding or planning to become pregnant during the study period.
- •History of chronic illness which may influence the cutaneous state.
- •Subjects participating in other similar cosmetics, devices or therapeutic trials or skin care products within the last four weeks.
结局指标
主要结局
Assessment of Reduction in Facial Wrinkles and Fine lines of Crow's feet area
时间窗: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
To evaluate the effectiveness of the test product in reducing the facial wrinkles and fine lines of Crow's feet area in healthy adult human subjects using VisioScan (Instrumental Readings).
次要结局
- Assessment of Facial Skin Elasticity(On Day 1 before product usage, on Day 30 and Day 60 after test product usage)
- Assessment in improvement in Skin Barrier Function - Transepidermal Water Loss (TEWL)(On Day 1 before product usage, on Day 30 and Day 60 after test product usage)
- Assessment of Skin Pigmentation(On Day 1 before product usage, on Day 30 and Day 60 after test product usage)
- Physician Global Assessments (PGA) scoring using Griffiths scale - Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness(On Day 1 before product usage, on Day 30 and Day 60 after test product usage)
- Assessment of Glogau Skin Age(On Day 1 before product usage, on Day 30 and Day 60 after test product usage)
- Assessment of Skin Color L-, a-,b- and ITA (Individual Topology Angle)(On Day 1 before product usage, on Day 30 and Day 60 after test product usage)
- Measurement of Skin Brightness and Skin Pigmentation(On Day 1 before product usage, on Day 30 and Day 60 after test product usage)
- Assessment in improvement in Skin Hydration(On Day 1 before product usage, on Day 30 and Day 60 after test product usage)
- Change in Facial Photograph(On Day 1 before product usage, on Day 30 and Day 60 after test product usage)
- Assessment of Product Perception - Sensory Attributes(On Day 1 before product usage, on Day 30 and Day 60 after test product usage)
- Assessment of Occurrence of Acne Lesions by Investigator Global Assessment (IGA) scoring(On Day 1 before product usage, on Day 30 and Day 60 after test product usage)
研究者
Dr Nayan Patel
Medical Director
NovoBliss Research Pvt Ltd
研究点 (2)
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