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CTRI Number  CTRI/2020/12/029938 [Registered on: 21/12/2020] Trial Registered Prospectively
Last Modified On: 29/06/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Patch Test]  
Study Design  Other 
Public Title of Study   Patch testing 
Scientific Title of Study   Evaluation of Dermatological Safety of Test Articles by Primary Irritation Patch Test on Healthy Adult Human Subjects (Single 24-hour Application) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
C3B00576, Batch 03 Version: 01, Dated 29 Oct 20  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel 
Designation  Principal Investigator 
Affiliation  Cliantha Research 
Address  Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India Phone 917966219500 Fax 917966219549 Mobile No 9909013286

Ahmadabad
GUJARAT
380054
India 
Phone  9909013286  
Fax  07966219549  
Email  nkpatel@cliantha.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Principal Investigator 
Affiliation  Cliantha Research 
Address  Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India Phone 917966219500 Fax 917966219549 Mobile No 9909013286


GUJARAT
380054
India 
Phone  9909013286  
Fax  07966219549  
Email  nkpatel@cliantha.com  
 
Details of Contact Person
Public Query  
Name  Ms Maheshvari Patel 
Designation  Associate Director Consumer Research 
Affiliation  Cliantha Research  
Address  Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India Phone 917966219500 Fax 917966219549 Mobile No 9909013286

Ahmadabad
GUJARAT
380054
India 
Phone  9909013236  
Fax  07966219549  
Email  mnpatel@cliantha.com  
 
Source of Monetary or Material Support  
Not Applicable 
 
Primary Sponsor  
Name  Vasu Research Centre 
Address  Vasu Research Centre A2/624-625/2 GIDC Makarpura Vadodara 390010 Phone 0265 2635553  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Not applicable  Not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nayan Patel  Cliantha Research   Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India Phone 917966219500 Fax 917966219549 Mobile No 9909013286
Ahmadabad
GUJARAT 		 9909013286
07966219549
nkpatel@cliantha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACEAS - IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  18 to 65 years healthy adult male & female with sensitive skin of varied Skin types (Oily, Dry, Normal and Combination) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1. Positive Control 2. Positive Control 3. Negative Control   1. 1 gm of SLS in 100 mL of distilled water 1 % w/v for 24 hours patch application 2. 3 gm of SLS in 100 mL of distilled water 3 % w/v for 24 hours patch application 3. Neat or 0.9gm of Sodium Chloride in 100ml of distilled water 0.9% w/v for 24 hours patch application  
Intervention  1. Shyamla oil 2. Shyamla herbal shampoo 3. Vasu uva face cream 4. Trichup oil 5. Trichup hair fall control oil 6. Trichup hair serum nutri shine 7. Trichup hair conditioner healthy long and strong 8. Trichup hair conditioner hair fall control 9. Trichup hair conditioner keratin 10. Trichup hair serum frizz control 11. Trichup hair serum thermal protection 12. Trichup natural hair oil black seed 13. Vasu cocoa butter care skin cream 14. Vasu shea butter care skin cream 15. Vasu all season skin cream 16. Greeko man shower gel charcoal 17. Greeko man clay mask charcoal 18. Greeko man beard wax 19. Vasu shower gel active deo mint 20. Vasu shower gel lavender 21. Vasu shower gel strawberry   1 Neat for 24 hours patch application 2 8% w/v sample solution for 24 hours patch application 3 Neat for 24 hours patch application 4 Neat for 24 hours patch application 5 Neat for 24 hours patch application 6 Neat for 24 hours patch application 7 8% w/v sample solution for 24 hours patch application 8 8% w/v sample solution for 24 hours patch application 9 8% w/v sample solution 10 Neat for 24 hours patch application 11 Neat for 24 hours patch application 12 Neat for 24 hours patch application 13 Neat for 24 hours patch application 14 Neat for 24 hours patch application 15 Neat for 24 hours patch application 16 8% w/v sample solution for 24 hours patch application 17 Neat for 24 hours patch application 18 Neat for 24 hours patch application 19 8% w/v sample solution for 24 hours patch application 20 8% w/v sample solution for 24 hours patch application 21 8% w/v sample solution for 24 hours patch application  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Age: 18-65 years (both inclusive) at the time of consent.
2) Sex: Males and non-pregnant/non-lactating females (preferably equal numbers of males and females).
3) Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
4) Subject who does not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
5) Subject is in good general health as determined by the Investigator on the basis of medical history.
6) Subject willing to maintain the test patches in designated positions for 24 Hours.
7) Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
8) Subject must be able to understand and provide written informed consent to participate in the study.
9) Subject is willing to refrain from vigorous physical exercise during the study period.
 
 
ExclusionCriteria 
Details  1) Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos, scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading.
2) Medication which may affect skin response and/or past medical history.
3) Subject with history of diabetes.
4) Subject with history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
5) Subject suffering from any active clinically significant skin diseases which may contraindicate.
6) Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer.
7) Participation in any patch test for irritation or sensitization within the last four weeks.
8) Subject having history of asthma or COPD (Chronic obstructive pulmonary disease).
9) Subject with self-reported Immunological disorders such as HIV positive, AIDS and systemic lupus erythematous.
10) 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.
11) Subject with known allergy or sensitization to medical adhesives, bandages.
12) Participation in other patch study simultaneously.
13) Use of any:
i. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application.
ii. Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
iii. Systemic or topical corticosteroids at patch site within four (4) weeks of test article application (steroids nose drops and/or eye drops are permitted)
iv. Topical drugs used at application site
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Safety assessment of products  30 minutes, 24 hours and 168 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/12/2020 
Date of Study Completion (India) 29/12/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="9" 
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  

To determine the potential of the test articles to cause cutaneous irritation in adult human subjects after single 24-hour occluded patch application.

 
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