CTRI/2023/08/056739招募中不适用
A Clinical study to evaluate the Irritation potential of the Good Karma Co Skin and personal care formulations on healthy human subjects.
The Good Karma Co1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年8月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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 IS405. 11 for dermal safety assessme****nt.
1. All Day Cream for Men- Cream
2. Hand and Foot Cream - Cream
3. Skin Renewal Cream - Cream
4. Body Cream with Lavender - Cream
5. Tea Tree Face Mist - Mist
6. Apple Cider Vinegar Face Toner - Toner
7. Under Eye Gel - Gel
8. Skin Brightening Gel - Gel
9. Pore Cleansing Gel - Gel
10. Coconut milk & Oatmeal Body Scrub- Scrub
11. Face Pack with Neem & Turmeric - Facepack
12. Body Lotion - Lotion
13. 10% Niacinamide Face Serum- Serum
14. Vitamin C Serum with Arbutin - Serum
15. Cleansing Make up Balm -
16. Blue Berry Night Gel - Gel
17. Intimate Wash for Women - Wash
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
- •1.Voluntary man/women between 18 and 65 years.
- •Photo type 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/nursing mothers
- •Scars, excessive terminal hair or tattoo on the studied area.
- •Henna tattoo anywhere on the body (in case of studies involving hair dyes).
- •Dermatological infection/pathology on the level of studied area.
- •Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye).
- •Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
- •Chronic illness which may influence the outcome of the study.
- •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).
- •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 1,Day 2, Day 8
次要结局
- Not applicable(Not applicable)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Skin Irritation test on Kapiva Skin Ritual Kumkumadi Glow Face OilCTRI/2023/08/056692Adret Retail Pvt Ltd24
尚未招募
不适用
skin saftey test of Herbscrubb PerfumeCTRI/2025/03/083460Herbscrubb24
尚未招募
不适用
Skin saftey test of Hi-Tech Henna Herbal Colour (Brown and Black)CTRI/2025/03/082170Hi-Tech Research and Analytical Centre24
尚未招募
不适用
skin saftey test of Maxnova Khaliyat The Better You Skin Brightening CreamCTRI/2025/06/088324Maxnova HealthCare24
尚未招募
不适用
skin saftey test of Botanical Luxuriate Amla and Rosemary shampoo-01CTRI/2025/06/088100Botanical Luxuriate Private Limited24