A Clinical Study to Evaluate the Spot Lightening Efficacy of a Face Care Formulation (Face Care/Soin Visage 2039174 88) On Pigmentary Spots in Healthy Indian Females over a period of 15 Weeks

L’Oréal Research & Innovation1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2025年10月28日最近更新: 2025年10月15日

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 60
试验地点: 1
主要终点: Evaluate the efficacy of the investigational product by assessing the following parameters:

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Study SummaryThis clinical study aims to assess the effectiveness and safety of a face care product called Formulation 2039174 88 in reducing dark spots, also known as hyperpigmentation, in healthy Indian women over a period of 15 weeks.

Hyperpigmentation occurs when the skin produces too much melanin, leading to dark patches or spots. It is more common in people with medium to dark skin tones and can be caused by sun exposure, acne, skin injuries, hormonal changes, or inflammation.

Study Phases

12 weeks of using the product two times a day
Followed by a 3-week period where the product is no longer used (relapse phase)

Study Design

Single-center, open-label, before-and-after study
Participants: Healthy Indian females aged 20 to 60 years, extended up to 70 years if needed, with at least one well-defined dark spot
Total duration: 133 days
28 days washout phase
84 days product use
21 days relapse phase

Primary Objectives

Evaluate improvement in the appearance of dark spots, including:
Contrast, density, and size of the spot
Skin color measurements using a spectrophotometer

Secondary Objectives

Capture facial images using VISIA CR imaging
Assess how long the product’s effects last after stopping use
Collect feedback from participants on skin appearance and product suitability
Monitor any skin irritation or side effects during the study

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: 20.00 Year(s) 至 60.00 Year(s)（—）
性别: Female

入选标准

•Healthy Indian female participants aged 20 to 60 years (both inclusive) (in case of difficulty in recruiting the participants the age can be extended to 70 years; applicable for phototypes V and VI).
•Participant with skin phototype ranging from III to VI according to spectrophotometer (CM-26d/CM-2600d) measurement on the unexposed area of the back on screening and baseline visit.
•Participants having at least one homogeneous, well-defined PIH spot of at least greater than or equal to 3mm diameter on their face using vernier caliper at screening visit and baseline visit.
•At least 20 participants with acne spot having clinical grading of with greater than or equal to 2 grades of contrast, greater than or equal to 2 grades of density and greater than or equal to 2 grades of size according to skin aging atlas, Asian skin type Volume 2, done by the investigator.
•Participant of all skin types (oily, dry, combination and normal) with minimum 15 participants having oily skin self-declared by the participants and perceived by the investigator.
•50 percent of the participants having sensitive skin (self-declared).
•Participants agree not to undergo any permanent makeup or cosmetic surgery or apply any self-tanning tool on the investigational area during the study.
•Participants agree not to apply any makeup or cosmetic product on investigational area except on lips and eyes (when required).
•Participants who are informed about the study objectives and procedures, study schedule, requirements and able to understand and comply with them.
•Participants willing to provide written informed consent and can read, write, and understand Hindi or English.
•Participants of childbearing potential must agree to undergo urine pregnancy testing.
•Participants of childbearing potential who are not sexually active or are using medically accepted contraceptive methods for at least one month before study initiation and throughout the study period.
•Accepted contraceptive methods include surgical sterilization (oophorectomy, hysterectomy, tubal ligation), oral, injectable or implant hormonal contraceptives, IUDs, condoms with spermicide, diaphragm or cervical cap with spermicide.

排除标准

•Women who are currently pregnant, breastfeeding (lactating), or planning to become pregnant during the study period.
•Participants who have started, stopped, or changed any hormonal treatment (such as contraceptive pills) within the last four weeks.
•Participants who have post-inflammatory erythema (PIE) spots, solar lentigines (sunspots), or melasma.
•Participants who have received any injections, undergone cosmetic surgery, or had permanent makeup on the study area within the last six months—or who are planning any such procedures during the study period.
•Participants who have used any depigmenting cosmetic product, or products containing retinol (or its derivatives), vitamin C (or its derivatives), or alpha/beta hydroxy acids (AHA/BHA) on the study area within one month before the study starts.
•Participants who have a known immune system disorder or any serious medical condition that, in the opinion of the investigator, could affect their safety during the study.
•Participants who have recently sunbathed, used self-tanning products, visited tanning salons, undergone phototherapy, or plan to do any of these during the study.
•Participants who are unable to follow study instructions or cannot be contacted in case of an emergency.