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CTRI Number  CTRI/2019/05/019182 [Registered on: 16/05/2019] Trial Registered Prospectively
Last Modified On: 11/09/2019
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 products on skin 
Scientific Title of Study   Evaluation of primary irritation potential in adult human subjects (Single 24-hour application) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
KLS19-TER-057 Version 00 dated 10 Apr 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  Cliantha Research Garden View Corporate House No. 7, Opp. Auda Garden, Bodakdev, Ahmedabad 380054, India Phone 917966219500 Fax 917966219549

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

Ahmadabad
GUJARAT
380054
India 
Phone  9909013286  
Fax  07966219549   
Email  nayan.patel@karmiclifesciences.com  
 
Details of Contact Person
Public Query  
Name  Ms Maheshvari Tamboli 
Designation  Head of Department consumer research 
Affiliation  Cliantha Research  
Address  Cliantha Research Garden View Corporate House No. 7, Opp. Auda Garden, Bodakdev, Ahmedabad 380054, India Phone 917966219500 Fax 917966219549

Ahmadabad
GUJARAT
380054
India 
Phone  9909013236  
Fax  07966219549  
Email  maheshvari.tamboli@karmiclifesciences.com  
 
Source of Monetary or Material Support  
Not applicable 
 
Primary Sponsor  
Name  Terrai Natural Products 
Address  833 Udyog Vihar, Phase-V Gurgaon 122016, Haryana INDIA Tel 91 124 4309994, 4309995  
Type of Sponsor  Other [Cosmeceutical Manufacturing Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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
nayan.patel@karmiclifesciences.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 
Intervention  1. Cream (batch no. MNC-01) 2. Cream (batch No MLC-02) 3. Shampoo (batch No. MCS-03) 4. Face Pack (batch No. MTFP-04) 5. Lotion (batch No. MMCR-05) 6. Face Wash (batch No. MCFW-06) 7. Shampoo (batch No. MAS-07) 8. Face Wash (batch No. MNFW-08) 9. Conditioner (batch No. MCC-09) 10. Lotion (batch No. MMCG-10)   1. Neat 2. Neat 3. 8% w/v in distilled water 4. Neat 5. Neat 6. 8% w/v in distilled water 7. 8% w/v in distilled water 8. 8% w/v in distilled water 9. Neat 10. Neat  
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 gm of SLS in 100 ml of distilled water 1 % w/v) 2. Negative Control (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. Subjects who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
5. Subjects in good general health as determined by the Investigator on the basis of medical history.
6. Subjects willing to maintain the test patches in designated positions for 24 Hours.
7. Subjects willing and able to follow the study directions, to participate in the study, returning for all specified visits.
8. Subjects must be able to understand and provide written informed consent to participate in the study.
9. Subjects willing to refrain from vigorous physical exercise during the study period.
 
 
ExclusionCriteria 
Details  1. Female subject is pregnant, planning for pregnancy, or lactating.
2. Subjects 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.
3. Medication which may affect skin response and/or past medical history.
4. Subjects having history of diabetes
5. Subjects have 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.
6. Subjects suffering from any active clinically significant skin diseases which may contraindicate.
7. Subjects having history of any skin diseases including eczema, atopic dermatitis or active cancer.
8. Participation in any patch test for irritation or sensitization within the last four weeks.
9. Subjects having history of asthma or COPD (Chronic obstructive pulmonary disease).
10. Subjects with Self-reported Immunological disorders such as HIV positive, AIDS and systemic lupus erythematous.
11. 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.
12. Subject with known allergy or sensitization to medical adhesives, bandages.
13. Participation in other patch study simultaneously.
14. 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 (steroidal 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   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Safety assessment of products  Irritation scoring at 30 minutes, 24 hours and 168 hours post patch removal 
 
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)= "27"
Final Enrollment numbers achieved (India)="27" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/05/2019 
Date of Study Completion (India) 11/06/2019 
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 test products by primary irritation patch test after single 24-hour patch application on healthy volunteers. Test products will be tested against control involving 24 subjects. Total study duration is 09 days.

 
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