An Open Label, Single-Arm, Clinical Study to Evaluate Efficacy and Safety of Vatika Dandruff Guard Shampoo in subjects with moderate to severe scalp dandruff

Dabur International Limited0 个研究点目标入组 34 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.Subject generally in good health and willing to give written informed consent and willing to follow study procedure.
•5.Subject has moderate to severe scalp dandruff based on the visual evaluations by dermatologist with visual scoring in between 5 to 10 at screening.
•6.Subject with visible flakes.
•7.SubjectÃ¢â?¬•s scalp is free from cuts and abrasions.
•8.Subject 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.
•9.Subject has hair that can be parted and held with hair clips to allow instrumental readings to be taken as 2 sites.
•10.Subject willing to complete the condition phase.
•11.Subject willing to use test product throughout the study period as instructed.
•12.Subject must be able to understand and provide written informed consent to participate in the study.
•13.Subject should be willing and able to follow the study protocol to participate in the study.

•1.Pregnant or breastfeeding or planning to become pregnant during the study period.
•2.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).
•3.Subject with excessive erythema, crusting or a significant number of pustules/papules on the scalp.
•4.Subject having any type of diabetes.
•5.History of skin cancer or treatment for any type of cancer within the last 2 years.
•6.History of prior use of antidandruff treatment on scalp within past 1 month.
•7.Subject using other marketed anti dandruff products during the study period.
•8.History of alcohol or drug addiction.
•9.Use of anti-histamines, anti-fungal medications or anti-inflammatories.
•10.Subject who have plans of shaving of scalp hair during the course of the study.
•11.Subject with a history or present condition of an allergic response to dandruff shampoos or any cosmetic products or component present in the test product.
•12.Participation in a similar clinical study within the previous 90 Days.
•13.Any other condition which could warrant exclusion from the study, as per the DermatologistÃ¢â?¬•s/investigatorÃ¢â?¬•s discretion.

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