To evaluate Efficacy and Safety study of Vatika Dandruff Guard Shampoo
- Registration Number
- CTRI/2022/03/040886
- Lead Sponsor
- Dabur International Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 34
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.Subjectââ?¬•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 Dermatologistââ?¬•s/investigatorââ?¬•s discretion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Effect of test product in Dandruff Reduction by using visual dandruff scoring scale at Day 01 (before application & after application)Timepoint: Day 15 and Day 30
- Secondary Outcome Measures
Name Time Method 1.To evaluate the effect of test product in reduction/prevention in visible dandruff flakes using Dandruff Meter DA 20 at Day 01 (before application & after application)Timepoint: Day 15 and Day 30;2.Effect of test product on improvement in the clinical condition of scalp on the basis i.e. Global improvement rating performed by the DermatologistTimepoint: Day 15 and Day 30;3.Effect of test product on reduction in itching evaluated through VAS (0-10) scoreTimepoint: change from baseline i.e. Day 01 before application to Day 15 and Day 30;4.Evaluation for healthy scalp and hair through subjective questionnaireTimepoint: Day 1 (before application & after application), Day 15 and Day 30;5.To assess the suitability of test product / subject response index [consumer perception about product] for all hair types (normal, oily, dry, colored (synthetic and henna colored) and permed hair)Timepoint: Day 15 and Day 30