CTRI/2026/02/104874尚未招募不适用
A RANDOMISED MULTICENTRIC PARALLEL GROUP STUDY TO EVALUATE THE TOLERANCE AND EFFICACY OF TEST PRODUCT ON SENSITIVE AND OILY SKIN IN SKIN BARRIER REPAIR
Loreal Research and Innovation1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年4月1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
- 50
- 试验地点
- 1
研究概览
简要总结
This is a multicentric randomized double blind parallel group before and after use efficacy study conducted in India and Brazil. The study will include 100 healthy male and female participants 50 in India and 50 in Brazil with at least 90 completers 45 per group.
Participants will be randomized in chronological order using a statistician prepared list stratified by LAST status positive or negative into two groups Group 1 Gel Cream plus Harsh Soap Group 2 Foaming Cleanser plus Gel Cream
All products will be applied twice daily for two weeks. During the washout phase all participants will use Harsh Soap. After washout Harsh Soap will be continued only in Group 1 until study completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Healthy male and female participants aged 18 to 55 years both inclusive 2 Participants having 100 percent self perceived oily skin 3 Participants having skin sensitivity confirmed through Baumann sensitivity skin questionnaire BSSQ 4 Participants having 50 percent positive to LAST Lactic acid stinging test 5 Participants with Phototype I to VI with at least 5 participants of each phototype II to V and at least 3 participants each of phototype I and VI based on ITA classification measured using Chromameter CR 400 on back of participants Phototype distribution across both countries India Phototype Grouping N 25 for phototype Type IV N 19 for phototype Type V N 6 for phototype Type VI Brazil N 5 for phototype Type I N 7 for phototype Type II N 38 for phototype Type III 6 Participants willing not to go for UV sessions sun tanning sun bathing or any sun exposure during the study duration 7 Participants who are SPF users may be included 8 Participants using their own non treatment sunscreen without antiaging or oil control claims may continue their usual product provided it has been used consistently for at least 1 month prior to study inclusion Participants willing to avoid use of any oral or topical medications which may interfere with the study results 9 Participants must agree to use their own SPF if non treatment SPF user and be willing to use only the investigational and auxillary product provided throughout the study duration 10 Participants who can read write and understand the informed consent document in their preferred language and are willing to give written informed consent 11 Participants willing and able to fulfil the study requirements follow instructions and study schedules 12 Female of childbearing potential self declaration pregnancy at screening visit and willing to undergo urine pregnancy test to be done at D0 13 Female of childbearing potential who is not sexually active or who is using an effective contraceptive method except systemic contraception for at least one month before the beginning of the study and throughout the study and also the contraceptive method must remain unchanged for at least 3 months prior to baseline.
排除标准
- •1 Participants with any facial permanent make up or tanning on the evaluation areas within one month prior to study initiation or during the study period 2 Participants using other cosmetic products on evaluation areas within 24 hours before screening visit 3 Participants who started hormone replacement therapies HRT or hormones for birth control less than 1 month prior to study entry or who plan on starting stopping or changing doses of HRT or hormones for birth control during the study 4 Participants with skin or any other medical condition that in opinion of investigator may interfere with the efficacy evaluation in study 5 Participants who are pregnant or lactating or who are planning to become pregnant during the study 6 History of allergies or hypersensitivity to any cosmetic ingredients of the investigational product 7 Any significant skin pathology in the test areas like rosacea severe acne eczema psoriasis or any active dermatological condition on face severe acne or eczema under the opinion of the investigator which can conflict with the study results 8 Any concomitant medical or surgical condition or using medication which may harm the participants or may interfere with the study assessments in the opinion of the investigator 9 Any topical or systemic treatment except their own SPF sunscreen that could interfere with the study treatments or assessments in the opinion of the investigator within 4 weeks prior to the screening visit 10 Any dermatological or facial procedure or aesthetic surgery laser peel microdermabrasion photo rejuvenation facial peeling etc taken 4 weeks before the start and during the study 11 Having participated in the last 1 month before screening or currently participating in another clinical or cosmetic study 12 Participants with inability to understand or follow study instructions 13 Unable to be contacted by phone in case of emergency.
研究者
Dr Sneha Sonker
CIDP Biotech India Pvt Ltd
研究点 (1)
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