A clinical study to evaluate the skin irritation potential of Lexicon multiple personal care products on healthy human volunteers
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
- Change in Skin Irritation Score-erythema & oedema
研究概览
简要总结
| The below products would be tested as per the guideline IS4011 for dermal safety assessment. |
1.CITTA Vitamin C Brightening Face Serum
2.CITTA Cica Gentle Face Scrub
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CITTA Regenerative Face Serum
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CITTA Radiance Serum with Gold
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CITTA Aqua Boost Face Gel
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CITTA Supercharged Hair Oil
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CITTA Strawberry Body Cream
8.CITTA Strawberry Creamy Body Scrub
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CITTA Anti-Dandruff Shampoo
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CITTA Deep Conditioning Hair Mask
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CITTA Regenerative Night Cream
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CITTA Cica Gentle Face Cleanser
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CITTA Vit C Brightening Face Scrub
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CITTA Brightening Face Cleanser
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CITTA Encapsulated Ubtan Face Wash
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CITTA Hair Growth Serum
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CITTA Invisible Sunscreen Serum SPF 50 PA++++
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CITTA Refreshing Body Cleanser
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CITTA Nourishing Body Cleanser
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CITTA Ceramides & White Tea Face Moisturiser
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CITTA Super Light Anti-Frizz Hair Serum
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CITTA Arabica Coffee Body Cream
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CITTA Coffee Creamy Body Scrub
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CITTA Beetroot Lip Balm
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CITTA Lip Glow Masque
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CITTA Soothing Body Milk
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CITTA Stretch Mark Cream
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CITTA Depigmentation Body Cream
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CITTA Soothing Sunscreen SPF 50 PA+++
The product will be tested for skin irritation on 24 human volunteers.
Assessment would be done on day 0, day 3, with followup visit on day 8 for erythema and Oedema scoring
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Voluntary man or women between 18 and 65 years.
- •Phototype III to V.
- •Having apparently healthy skin on test area.
- •For whom the investigator considers that the compliance will be correct.
- •Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
- •Having signed a Consent Form.
- •Willingness to avoid intense UV exposure on test site (sun or artificial UV) during the course of the study.
- •Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna), during the course of the study.
- •Should be able to read and write (in English, Hindi or local language).
- •Having valid proof of identity and age.
排除标准
- •Pregnant or nursing mothers 2.Scars, excessive terminal hair or tattoo on the studied area 3.Henna tattoo anywhere on the body (in case of studies involving hair dyes) 4.Dermatological infection or pathology on the level of studied area 5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye) 6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
- •7.Chronic illness which may influence the outcome of the study.
- •8.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month) 9.Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
结局指标
主要结局
Change in Skin Irritation Score-erythema & oedema
时间窗: Day 0, Day 2 and Day 8
次要结局
- Not Applicable(Not Applicable)