Assessment of topical formulae in comparison to positive reference for their efficacy on skin acne related imperfections through instrumental and dermatologist assessment, over a 12 week daily 1x/2x home usage

LOrÃ©al India Pvt. Ltd1 个研究点分布在 1 个国家目标入组 280 人开始时间: 2024年5月6日最近更新: 2024年5月21日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 280
试验地点: 1
主要终点: 1.To compare the efficacy of four topical formulae on acne prone and oily skin of subjects as

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To compare the efficacy of four topical formulae on acne prone and oily skin of subjects as determined by below mentioned parameters:

Acne lesion counts (inflammatory & non-inflammatory). Clinical grading of Acne using IGA scale. Evaluation of sebum casual level and sebum excretion rate using Sebumeter SM 815Â®.

Tocompare topical formulae effectiveness in reducing the contrast (between spots and bare skin) and intensity of PIH spots (less than equal to 3mm) by instrumental measurements with Spectrophotometer
To compare efficacy of four topical formulae in their effect on skin barrier function by measurement of TEWL and hydration level.

研究设计

研究类型: Interventional
分配方式: Other
盲法: Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 35.00 Year(s)（—）
性别: All

入选标准

•1 Healthy Male & Female subjects aged
•35 years (both included) (subjects to be enrolled in equal ratio as per gender). 2 Subjects having skin phototype IV and V (Fitzpatrick) (subjects to be enrolled in equal ratio as per phototype)). 3 Subjects having body Mass Index in the range of 18 to 25 kg per meter square. 4 Subjects having oily skin type according to investigator 5 Subjects with mean sebum casual level on forehead less than 100 Î¼g per cm square. 6 Subjects presenting with mild (grade 2) to moderate acne (grade 3) (max 2 nodules) severity on an IGA scale from 0 to 4, according to the investigator. 7 Subjects presenting acne lesion count: less than equal to 10 to greater than equal to 25 inflammatory acne lesions on whole face (Forehead, cheeks, nose, jawline and chin). less than 25 to greater than equal to 100 non-inflammatory/comedonal acne lesions on Forehead, cheeks, nose, jawline and chin. max 2 nodules (greater than 1cm). 8 Subjects having a well-defined homogenous PIH spot of less than equal to 3mm on whole face with adjacent non-pigmented skin. 9 Subjects willing not to go for U.V. sessions/sun tanning/sun-bathing during the study duration. 10 Subjects agreeing to use only the supplied washout product and investigational product provided during the study. 11 Subjects informed about the study objectives and procedures and able to understand them. 12 Subjects willing and able to fulfil the study requirements and schedule. 13 Subjects willing to provide written informed consent and are able to understand English or Hindi. 14 Subjects willing to avoid oily, greasy, junk food and high sugar food items, as much as possible during the study period. 15 Subjects willing not to apply hair oil and wash their hair within 48 hours prior to the assessment visit. 16 Subjects willing to not to expose themselves in sun and must carry umbrella/cap/hat if going out. 17 Female of childbearing potential willing to undergo urine pregnancy test [self-declared by subject on screening visit and test to be done on Visit 2 (Baseline visit), Visit 5, Visit 6, Visit 7 & Visit
•18 Female of childbearing potential, who is not sexually active, or who is using an effective contraceptive method for at least one month before the beginning of the study, and throughout the study.

排除标准

•1 Subjects who are pregnant or lactating or who are planning to become pregnant during the study.
•2 Subjects who have used anti-acne products within the last 30 days.
•3 Subjects who have only noticed an increase of acne due to protective face mask usage.
•4 Subjects that are under the treatment/care of a dermatologist.
•5 Subjects who have started, stopped or changed his/her hormonal treatment (including contraceptive pill) in the previous one month prior to the study.
•6 History of allergies, hypersensitivity or any serious reactions to any cosmetic products.
•7 Any significant skin pathology in the test areas, like rosacea, or eczema.
•8 Any significant medical condition that would interfere with the participation in the study, as per the opinion of the Investigator.
•9 Any concomitant medical/surgical condition or using medication which may harm the subject or may interfere with the study assessments, as per opinion of the Investigator.
•10 Any dermatological procedure on the test areas (laser peel, dermabrasion etc.) taken 4 weeks before the start of the study and during the study.
•11 Subject reported or planning to sun-bathe or to overexpose to UV-light (mountains sports, phototherapy, tanning salon useâ€¦) for aesthetic or therapeutic reason the month before the study start or during the study.
•12 Having participated in the last 30 days before screening or currently participating in another clinical study.
•13 Unable to be contacted by phone in case of emergency.