CTRI/2026/02/103568尚未招募不适用
A clinical study to evaluate the efficacy and safety of a test product in providing anti-ageing benefits in healthy female trial participants
Ichimaru Pharcos Co Ltd.,2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月23日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
研究概览
简要总结
This is a multicentric, multi-ethnic, open-label, full-face efficacy and safety study conducted over a period of 8 weeks in healthy adult female participants. The study comprises five visits including screening, baseline (Day 0), and follow-up assessment visits at Week 2, Week 4, and Week 8. A total of 40 participants will be enrolled across study sites, with approximately 35 participants expected to complete the study. Efficacy and safety will be evaluated through dermatological assessments, non-invasive instrumental measurements, imaging techniques, and participant self-assessments conducted under standardized conditions. Participants will apply the test product twice daily throughout the study period, and compliance will be monitored using participant diaries and product accountability.
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
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Healthy adult female participants in general good health, as determined by medical history, general physical examination, and dermatological assessment.
- •Female participants aged 25 to 50 years (both inclusive) at the time of screening.
- •Presence of at least two clearly defined dark spots (including post-inflammatory hyperpigmentation, acne spots, or age spots) on each side of the face.
- •Presence of visible fine lines and wrinkles, as assessed by the dermatologist.
- •Presence of under-eye dark circles and visible facial pores, as assessed by the investigator.
- •Participants free from excessive facial hair and without active acne, cuts, abrasions, fissures, wounds, lacerations, or any other active dermatological condition on the face, as determined by the investigator.
- •Participants willing to refrain from using any facial skincare products, treatments, or home remedies other than the provided test product for the duration of the study.
- •Participants willing to avoid cosmetic or dermatological procedures such as bleaching, facials, chemical peels, laser treatments, or similar procedures on the face during the study period.
- •Participants willing to avoid excessive sun exposure (defined as more than 30 minutes per day) and to use physical sun protection (e.g., umbrella or hat) during unavoidable exposure.
- •Participants willing to provide written informed consent, photography consent, and comply with all study visits and protocol requirements.
- •Participants who are willing and able to comply with the study protocol and investigator instructions.
排除标准
- •Presence of any clinically significant local skin irritation, dermatological disease, or active facial skin condition that may interfere with study evaluations.
- •Use of any systemic or topical medication, including dietary or food supplements, within 1 month prior to screening, that may affect study outcomes, as determined by the investigator.
- •History or presence of any clinically significant systemic disease, chronic illness, or major surgery within the past 1 year.
- •Unwillingness to remove facial jewellery (e.g., earrings, nose ring, necklace) during VISIA-CR imaging procedures.
- •Ongoing dermatological treatment involving the face at the time of screening or during the study period.
- •Inability or unwillingness to maintain consistent routine use of personal cleanser, makeup, or sunscreen without changes during the study period.
- •Participants with daily sunscreen use or daily/full makeup application will be excluded.
- •Known hypersensitivity or allergy to cosmetic products, cleansing agents, creams, lotions, metals, artificial jewellery, or any ingredient of the test product.
- •Pregnant or lactating participants (self-reported).
- •Participation in any clinical, cosmetic, or investigational study within 1 month prior to screening.
- •History of facial skin allergy, atopic dermatitis, psoriasis, or other chronic inflammatory skin conditions involving the face.
- •Employees of the sponsor, contract research organization (CRO), or study site staff directly involved in the conduct of the study.
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd
研究点 (2)
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