CTRI/2025/07/090488尚未招募不适用
A clinical study to evaluate cosmetic efficacy and safety of an antioxidant serum in reducing appearance of wrinkles, expression lines and dark spots in healthy adult participants.
KAYURA EFFECT LLP1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年7月30日
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Dermatological assessment of fine line/wrinkles and coarse wrinkling/lines
研究概览
简要总结
This is an open label, non-randomized, single-centre, single arm clinical study to evaluate cosmetic efficacy and safety of an antioxidant serum in reducing appearance of wrinkles, expression lines and dark spots in healthy adult participants.
The potential participants will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the participants.
All eligible participants will undergo clinical evaluation by a Dermatologist, instrument evaluation and subjective evaluation. Safety will be assessed throughout the study by monitoring adverse events.
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 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy adult males and non-pregnant/non-lactating females with age 30 to 55 years (both inclusive at the time of consent).
- •Participants having fine line/wrinkles score of “1” (Occasional number of fine lines widely spaced) or “2” (Few number of discreet fine lines) as per Physician Global Assessment (PGA).
- •Participants with at least 2 dark spots on the face.
- •Participants with uneven skin tone and with dull skin.
- •Participants having good general health as determined by the Investigator on the basis of medical history.
- •Participants of childbearing potential must have a negative urine pregnancy test performed at screening/enrollment visit.
排除标准
- •Participants having any active dermatological skin conditions (e.g., acne, eczema, psoriasis, rosacea etc.), that might interfere with clinical assessments.
- •Participants having excessive hair, moles, open wounds, cuts, abrasions, irritation symptoms, tattoos, scars, sunburn or any dermatological condition on the test site(s) that can interfere with the reading.
- •Participants who are receiving topical or systemic treatments for fine line/wrinkles and pigmentation.
- •Participants are unwilling to avoid unprotected sun or other UV radiation exposure during the study period.
- •Chronic illness which may influence the cutaneous state.
- •Participants with known allergy or sensitivity to cosmetic products and/or any ingredients of the test product.
- •Participants having a history of diabetes, acute cardiac and circulatory diseases, HIV, hepatitis.
- •Participants with history of drug and alcohol abuse.
- •Any other condition which could warrant exclusion from the study, as per the Dermatologist’s/investigator’s discretion.
结局指标
主要结局
Dermatological assessment of fine line/wrinkles and coarse wrinkling/lines
时间窗: Day 00, Day 15, Day 30, Day 45 and Day 60
次要结局
- Dermatological assessment of skin tone evenness(Day 00, Day 15, Day 30, Day 45 and Day 60)
- Instrumental assessment of skin lightening, skin gloss/radiance, fine lines/wrinkles, dark spots and skin texture(Day 00, Day 15, Day 30, Day 45 and Day 60)
- Participant Satisfaction Questionnaire(Day 15, Day 30, Day 45 and Day 60)
研究者
Dr Bhagirath Patel
Cliantha Research
研究点 (1)
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