CTRI/2019/06/019494尚未招募2 期
“Efficacy evaluation of PR/HC/1718/013 formulations in conferring dark spot reduction, wrinkle reduction, acne reduction and enhanced skin even tone in healthy human volunteers.â€
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.To Study the efficacy in reducing hyper pigmentation
研究概览
简要总结
Subjects will beadvised to apply cream twice daily on clean skin and affected area for 1 month. The efficacy of product will be assesed for improvement in complexion, reduction in acne lesions, darkness, hyper pigmentation and wrinkles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject willing to give a written informed consent and come for regular observations 2.Subject is a healthy adult, male or female, in the age range of 18 and 40 years 3.Subject has at least 2 prominent wrinkles on crow feet area 4.Subject has at least 2 hyperpigmentary spots on face that are freckles, age spots, post inflammatory hyperpigmentation spots like post acne marks, etc on face 5.Facial acne, with: a.
- •Inflammatory facial lesions (papules/pustules/nodules/cysts) b.
- •Non inflammatory facial lesions if open (blackhead) and if closed (whitehead) comedones c.
- •Mild to moderate acne with nodular abcesses 6.Subject has not participated in a similar clinical investigation in the past three months.
- •7.Subject who is willing to abstain from using any fairness product, sunscreens, natural/ ayurvedic treatments or other home remedies and also willing to abstain from undergoing any facial treatments such as facial masks, packs, bleaching, etc either at home or at parlour during the entire study course.
- •In case of having used fairness product in the near past, should be willing to undergo a wash out period of 1 week, wherein they should abstain from applying any product other than the provided cleanser on face.
- •8.Male subjects who are willing to maintain their facial skin condition as shaved at baseline and during the entire study course.
- •9.Subject who shows no skin sensitivity symptoms to the investigational products during the skin sensitivity test.
- •10.Female subjects of reproductive age group should undergo UPT at time of screening visit.
排除标准
- •Subject with a known history or present condition of allergic response to any cosmetic/pharmaceutical products, toiletries or their ingredients including fragrance.
- •Subject who has used any systemic medication (antibiotics, oral contraceptive pills, retinoids, steroids, spironolactone or any anti acne medication) within past 4 weeks or any topical facial medication within 2 weeks prior to study commencement, which could compromise the study.
- •Subject with a medical history of disease or condition or a concurrent illness or pre-existing or dormant dermatologic condition (psoriasis, rosacea, rashes, eczema etc.) that could interfere with the study results.
- •Subject with excessive facial hair or scars, which could interfere with evaluation.
- •Subject with a history of having used a similar product during or since 1 week prior to the scheduled study commencement.
- •Subject who is currently pregnant (as confirmed by the urine pregnancy test) or nursing or contemplating pregnancy during the study course.
结局指标
主要结局
1.To Study the efficacy in reducing hyper pigmentation
时间窗: Baseline, Day 15, Day 30
3.To study the efficacy in reduction in acne lesion counts
时间窗: Baseline, Day 15, Day 30
4.To study Reduction in white and black heads, reduction in dark circles and redness on MASI scoring
时间窗: Baseline, Day 15, Day 30
5.Global Assessment Grade for improvement in complexion / dark spots on the face and neck
时间窗: Baseline, Day 15, Day 30
2.To study the efficacy in reducing wrinkle.
时间窗: Baseline, Day 15, Day 30
6.Patient Satisfaction Questionnaire, Feeling of looking better, Hydration and moisture to the skin, Radiance of the skin
时间窗: Baseline, Day 15, Day 30
次要结局
- Assessment of tolerability of study drug by assessing adverse events, serious adverse events during the study period.(Assessment of Global evaluation of overall improvement in complexion on the face and neck by investigator and subject)
研究者
研究点 (1)
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