| CTRI Number |
CTRI/2022/03/040886 [Registered on: 07/03/2022] Trial Registered Prospectively |
| Last Modified On: |
13/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Consumer Cosmetic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate Efficacy and Safety study of Vatika Dandruff Guard Shampoo |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B01590 Version: 01, Dated 14 Feb 22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad
Ahmadabad
GUJARAT
380054
India |
| Phone |
917966219500 |
| Fax |
917966219549 |
| Email |
pjoshi@ofacto.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad
Ahmadabad
GUJARAT
380054
India |
| Phone |
917966219500 |
| Fax |
917966219549 |
| Email |
pjoshi@ofacto.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director-Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad
Ahmadabad
GUJARAT
380054
India |
| Phone |
917966219500 |
| Fax |
917966219549 |
| Email |
ssethi@ofacto.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
|
|
|
Primary Sponsor
|
| Name |
Dabur International Limited |
| Address |
P. O. Box 16944
Jebel Ali Free Zone,
Dubai - U.A.E.
Phone#: (971-4) 8817756, 8817689
Fax: (971-4) 8817732 |
| Type of Sponsor |
Other [Personal Care and Wellness Industry- Global] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parth Joshi |
Cliantha Research |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT |
8000085049
917966219549
pjoshi@ofacto.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
36 Adult healthy subjects of both sex (preferably with equal numbers) with age between 18 and 60 years having moderate to severe scalp dandruff (visual scoring in between 5 to 10) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Vatika Naturals Dandruff Guard Shampoo |
Approx. 5-10 ml of shampoo to be applied on scalp and hair, work up a good lather and gently massage it over entire scalp. Rinse hair and scalp with water.
Shampoo to be used thrice a week for a duration of 30 days.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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. Subject’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. |
|
| ExclusionCriteria |
| Details |
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 Dermatologist’s/investigator’s discretion. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Effect of test product in Dandruff Reduction by using visual dandruff scoring scale at Day 01 (before application & after application) |
Day 15 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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) |
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 Dermatologist |
Day 15 and Day 30 |
| 3. Effect of test product on reduction in itching evaluated through VAS (0-10) score |
change from baseline i.e. Day 01 before application to Day 15 and Day 30 |
| 4. Evaluation for healthy scalp and hair through subjective questionnaire |
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) |
Day 15 and Day 30 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/03/2022 |
| Date of Study Completion (India) |
07/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is 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.
The potential subjects will be screened as per the
inclusion and exclusion criteria only after obtaining written informed consent
from the subjects.
There are total 4 visits in the study i.e.
Visit
01: Screening and conditioning period (Within
30 days prior to Day 01 including at least 07 days of conditioning period)
Visit
02: Enrolment (Day 1) – Pre and Post wash assessment
Visit
03: Evaluation Phase [Day 15 (± 2 Days)]
Visit
04: Evaluation Phase and End of Study (EOS) [Day 30 (± 2 Days)] |