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CTRI Number  CTRI/2021/11/037783 [Registered on: 03/11/2021] Trial Registered Prospectively
Last Modified On: 08/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Patch Test]  
Study Design  Other 
Public Title of Study   Primary Irritation patch Testing 
Scientific Title of Study   Evaluation of Dermatological Safety of Test Articles by Primary Irritation Patch Testing on Healthy Adult Human Subjects (Single 24 hour Application) 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
C3B00576-CHA-A, Version 02, Dated: 02 Aug 21  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 380054, India

Ahmadabad
GUJARAT
380054
India 
Phone  8000085049  
Fax  07966219549  
Email  pjoshi@cliantha.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 380054, India


GUJARAT
380054
India 
Phone  8000085049  
Fax  07966219549  
Email  pjoshi@cliantha.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 380054, India

Ahmadabad
GUJARAT
380054
India 
Phone  9825784942  
Fax  07966219549   
Email  ssethi@cliantha.com  
 
Source of Monetary or Material Support  
Not Applicable 
 
Primary Sponsor  
Name  Vedistry Pvt Ltd Charak Pharma 
Address  21, Evergreen Industrial Estate, Shakti Mills Lane, Off E. Moses Road, Mahalaxmi Mumbai - 400011 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Parth Joshi  Cliantha Research   Garden View Corporate House No. 7, Opp. Auda Garden, Consumer Research Department,Room No. 01, Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT 		 8000085049
07966219549
pjoshi@cliantha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACEAS  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 
Intervention  Moha - 5 In 1 Hair Oil  Neat, 0.04 mg, single dose, topical application 
Intervention  Moha - Aloe Vera Gel  Neat, 0.04 mg, single dose, topical application 
Intervention  Moha - Anti-Dandruff Hair Oil  Neat, 0.04 mg, single dose, topical application 
Intervention  Moha - Anti-Dandruff Shampoo  8% w/v sample solution, 0.04 mg, single dose, topical application 
Intervention  Moha - Foot Care Cream  Neat, 0.04 mg, single dose, topical application 
Intervention  Moha - Herbal Face Wash  8% w/v sample solution, 0.04 mg, single dose, topical application 
Intervention  Moha - Herbal Hair Conditioner  8% w/v sample solution, 0.04 mg, single dose, topical application 
Intervention  Moha - Herbal Hair Serum  Neat, 0.04 mg, single dose, topical application 
Intervention  Moha - Herbal Scrub  Neat, 0.04 mg, single dose, topical application  
Intervention  Moha - Herbal Shampoo  8% w/v sample solution, 0.04 mg, single dose, topical application 
Intervention  Moha - Herbal Sunscreen Lotion With SPF50  Neat, 0.04 mg, single dose, topical application 
Intervention  Moha - Lip Balm  Neat, 0.04 mg, single dose, topical application 
Intervention  Moha - Moisturizing Lotion  Neat, 0.04 mg, single dose, topical application 
Intervention  Moha - Nail Care Cream  Neat, 0.04 mg, single dose, topical application 
Intervention  Moha - Rejuvenating Massage Oil  Neat, 0.04 mg, single dose, topical application 
Intervention  Moha - Rose And Almond Soap  8% w/v sample solution, 0.04 mg, single dose, topical application 
Intervention  Moha - Rose Mist  Neat, 0.04 mg, single dose, topical application 
Intervention  Moha - Scrub Soap  8% w/v sample solution, 0.04 mg, single dose, topical application 
Intervention  Moha - Shower Gel  8% w/v sample solution, 0.04 mg, single dose, topical application 
Intervention  Moha - Sulfate-Free Shampoo  8% w/v sample solution, 0.04 mg, single dose, topical application 
Intervention  Moha: Soap  8% w/v sample solution, 0.04 mg, single dose, topical application 
Comparator Agent  Negative Control   Neat / 0.9gm of Sodium Chloride in 100ml of distilled water (0.9% w/v) , 0.04 mg, single dose, topical application 
Comparator Agent  Positive Control   1 gm of SLS in 100 mL of distilled water (1 % w/v) , 0.04 mg, single dose, topical application 
Comparator Agent  Positive Control   3 gm of SLS in 100 mL of distilled water (3 % w/v) , 0.04 mg, single dose, topical 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 of patch removal Day 02, 24 hours, Day 03 and 168 hours, Day 09 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
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)   06/11/2021 
Date of Study Completion (India) 17/11/2021 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Cosmetics and Ayurvedic Medicines commonly referred to as personal care products are used by most people on a day to day basis. These products and materials can be potential sources of cutaneous irritation which makes it a necessity to ensure their safety for usage.

Several types of test methods are used widely for the evaluation of safety of cosmetics in human, which include single patch test, in-use test, 7/14/24 Days cumulative irritation patch testing, human repeated insult patch test (HRIPT) for irritation and sensitization potential.

Primary Irritation Patch Test is performed to evaluate the primary skin irritation that can range from none, mild, moderate to severe irritation. This results from reversible inflammatory changes in the skin following the application of a test substance depending on the irritation potential of the product. Based on the severity of irritation caused due to the interaction of ingredients or composition of the test substance with the skin can cause perceivable sensations or symptoms. On the basis of this, the possible hazards likely to arise from exposure of the skin to the test substance can be assessed. To know the safety or possible irritant potential of these products, it should be tested in small group of humans before release of the product in market. This allows to measure and evaluate the probable inflammatory response to an irritant which occurs only at the site of exposure. The response tends to be universal (produces a reaction in most individuals) and depends on the strength and duration of exposure.

 
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