An open-label, single-arm, single centre, interventional, prospective, clinical safety, efficacy and in-use tolerability study of ThriveCo Scalp Kit (ThriveCo Exfoliating Scalp Scrub and ThriveCo Scalp Vitalizing Serum) and ThriveCo Acne Kit (ThriveCo Acne Cleanser and ThriveCo Acne Serum) in healthy adult human subjects having complaint of scalp dandruff and facial acne. - Nil

Anveya Living Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年12月19日

试验速览

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•1)Age: 18 - 50 above (both inclusive) old at the time of consent.
•2)Sex: Healthy males and non-pregnant/non-lactating females.
•3)Females of childbearing potential must have a self-reported negative urine pregnancy test.
•4)Subjects are generally in good general health as determined from recent medical history.
•5)Subjects with mild to moderate dandruff status as per ASFS at screening.
•6)Subject have unwashed and untreated scalp for 5 days.
•7)Subject must have mild to moderate acne on their skin (IGA score 2 to 3).
•8)The subject is willing and able to follow the study directions, participate in the study, returning for all specified visits.
•9)The subject must be able to understand and provide written informed consent to participate in the study.

•1)Subject with known allergy or sensitization to test treatment ingredients.
•2)History of dermatological condition of scalp other than dandruff.
•3)History of alcohol or drug addiction.
•4)Subject using other marketed products for acne and dandruff control and/or hair growth products during the study period.
•5)Subject who have plans of shaving scalp hair during the study.
•6)The subject has skin irritation, open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the face that can interfere with the reading.
•7)Be wearing any facial makeup on the day of the study visit.
•8)Medication which may affect skin and scalp response and/or past medical history.
•9)Subject has any concurrent skin disease.
•10)Subject has taken any systemic corticosteroids, anti-bacterial, immunosuppressant drugs or abradant facial procedures in the past 30 days.
•11)Subjects who are likely to engage in activities that involve excessive exposure to sunlight.
•12)Pregnant or breastfeeding or planning to become pregnant during the study period.
•13)An individual who has a medical condition or is taking or has taken a medication which, in the Investigator’s judgment, makes the subject ineligible or places the subject at undue risk.
•14)Subjects who have been treated with topical steroids, retinoids or other topical drugs within 2 weeks prior to entry to the study.
•15)Participation in other clinical studies simultaneously.

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