A monocentric, single group, 12 week trial to evaluate the benefits of a serum in reducing expression lines, improving texture and radiance of facial skin in women and its in use tolerance.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- 1. 3D Imaging for expression lines (nasolabial folds, forehead wrinkles, wrinkles &fine
研究概览
简要总结
Argireline can help increase collagen production. Increased collagen production can
result in plumper-looking skin and improved skin elasticity, leading to reduced visible wrinkles.
Topical niacinamide provides benefits on skin such as , improving appearance of texture,
hyperpigmentation, and red blotchiness. In addition, it also helps in improvement in wrinkles,
firmness (elasticity), and sallowness (yellowing).Niacinamide and Phytic acid also gives a skin
brightening effect.
FirmX, which contains all the above mentioned ingredients is claimed to reduce the appearance
of expression lines, improve skin texture and skin radiance.
This purpose for this study is to evaluate the benefits of the serum objectively by using 3D
imaging and skin GlossMeter and subjectively by self-assessment questionnaire
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Voluntary women from 30 years to 65 years of age.
- •Volunteers with expression lines (nasolabial folds, forehead wrinkles, wrinkles &fine lines in crow’s feet area, marionette lines, undereye wrinkles & Fine lines).
- •Having apparently healthy skin on test area.
- •Willingness to discontinue the use of other cosmetic products on face during the course of the study.
- •Willing to avoid unusual sun exposure as far as possible for the entire study duration.
- •Accepting not to use products with the same end benefit during the entire study duration.
- •Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
- •Ready to provide consent, having been informed orally and in writing of all information concerning the study procedures and study objectives.
排除标准
- •Female who is pregnant by UPT or lactating.
- •Any cutaneous conditions on test site (scars, moles, papules etc).
- •Participants hypersensitive to any of the components of the test product.
- •Participants having any hard damage to skin (e.g., excessive sunburn or suntan).
- •Participants on any systemic medical treatment which may interfere with the performance of the study treatment (presently or in the past 1 month).
- •Participant in an exclusion period or participating in any clinical trial within 30 days prior to screening.
结局指标
主要结局
1. 3D Imaging for expression lines (nasolabial folds, forehead wrinkles, wrinkles &fine
时间窗: Day 0, Day7, Day 90
lines in crow’s feet area, marionette lines, undereye wrinkles and Fine lines)
时间窗: Day 0, Day7, Day 90
2. 3D Imaging for skin texture (skin smoothness).
时间窗: Day 0, Day7, Day 90
3. Skin radiance using Glossmeter.
时间窗: Day 0, Day7, Day 90
4. Self-assessment for product efficacy.
时间窗: Day 0, Day7, Day 90
次要结局
- 1. Clinical evaluation for in-use skin tolerance.(2. Self-assessment questionnaire for in use tolerance.)
研究者
Dr Rajiv Joshi
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.