An Open Label, Single-Arm, Multicentre, Clinical Study to Evaluate Efficacy and Safety of Anti-Dandruff Shampoo (HAMC-081905) in subjects with dandruff

The Himalaya Drug Company0 个研究点目标入组 99 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1.Age: 18 to 60 years (both inclusive) at the time of consent.
•2.Sex: Healthy male or non-pregnant/non-lactating female.
•3.Female subjects of childbearing potential must have a negative urine pregnancy test performed on screening visit and Enrolment.
•4.Subjects generally in good health and willing to give written informed consent and willing to follow study procedure.
•5.Subjects with dandruff determined by ASFS score 24 to 48 with itching and flaking.
•6.Subjects with visible flakes.
•7.Subjects willing to refrain from using other products on the scalp other than those provided, including other shampoos/conditioners, scalp and hair treatment and oils/ products that has anti-dandruff action during the study period.
•8.Subjects completing the conditioning phase.
•9.Subjects willing to use test product throughout the study period.
•10.Subjects must be able to understand and provide written informed consent to participate in the study.
•11.Subjects should be willing and able to follow the study protocol to participate in the study.

•1)History of any dermatological conditions of the scalp (other than dandruff or seborrheic dermatitis) that would interfere with the diagnosis or assessment (e.g. psoriasis, eczema, atopic dermatitis, or other skin/scalp infections).
•2)Subjects with excessive erythema, crusting or a significant number of pustules/papules on the scalp.
•3)History of skin cancer or treatment for any type of cancer within the last 2 years.
•4)History of prior use of antidandruff treatment on scalp within past 1 month.
•5)Participation in a similar clinical study within the previous 90 Days.
•6)Subjects with a history or present condition of an allergic response to dandruff shampoos or any cosmetic products or component present in the test product.
•7)Any other condition which could warrant exclusion from the study, as per the DermatologistÃ¢â?¬•s/investigatorÃ¢â?¬•s discretion

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