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CTRI Number  CTRI/2019/10/021492 [Registered on: 01/10/2019] Trial Registered Prospectively
Last Modified On: 13/12/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Patch test]  
Study Design  Other 
Public Title of Study   Safety Assessment of Herbal Transdermal Pain Relief Patch 
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 
KLS18-KLS-264 Version 01 Dated 18 Sep 19  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 91-79-66219500 Fax 91-79-66219549

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 91-79-66219500 Fax 91-79-66219549


GUJARAT
380054
India 
Phone  9909013286  
Fax  07966219549  
Email  nkpatel@cliantha.com  
 
Details of Contact Person
Public Query  
Name  Ms Maheshvari Patel 
Designation  HOD-Consumer Research 
Affiliation  Cliantha Research 
Address  Consumer Research Department, Garden View Corporate House No. 7, Opp. Auda Garden, Bodakdev, Ahmedabad 380054, India Phone 91-79-66219500 Fax 91-79-66219549

Ahmadabad
GUJARAT
380054
India 
Phone  9909013236  
Fax  07966219549  
Email  mnpatel@cliantha.com  
 
Source of Monetary or Material Support  
Not Applicable 
 
Primary Sponsor  
Name  Unexo Lifesciences Pvt Ltd 
Address  B-16 Sector 4 Bawana Industrial Area Delhi 110039 INDIA Phone 91 9711265545  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
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
Ahmadabad
GUJARAT 		 9909013286
07966219549
nkpatel@cliantha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OM Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Varied skin types 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1. Sodium Lauryl Sulphate (SLS) analytical grade 1 % w/v 2. Sodium chloride (Normal Saline Solution) Injection IP 0.9 % w/v  1. Positive Control-1 (1 gm of SLS in 100 ml of distilled water 1 % w/v) 2. Negative Control (Neat / 0.9gm of Sodium Chloride in 100 ml of distilled water 0.9% w/v) 
Intervention  1. Viopatch Regular (Batch No. VPT/P39) 2. Viopatch Large (Batch No. VPT/P38) 3. Viopatch XL (Batch No. VPT/P40)  1. Neat 2. Neat 3. Neat 
 
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:
a. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to enrolment in the current study.
b. Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
c. Systemic or topical corticosteroids at patch site within four (4) weeks of investigational product application (steroids nose drops and/or eye drops are permitted)
d. Topical drugs used at application site 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Safety assessment of products  Baseline, 0 hour, 24 hours and 168 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2019 
Date of Study Completion (India) 18/10/2019 
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   Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types. Test products will be tested against controls involving 26 subjects. Total study duration is 09 days. 
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