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CTRI Number  CTRI/2021/12/038364 [Registered on: 02/12/2021] Trial Registered Prospectively
Last Modified On: 02/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetics and Positive-Negative Irritant -Control]  
Study Design  Other 
Public Title of Study   Skin Safety Experiment (Validation Study) of Test Products, Positive and Negative Controls by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Subjects. 
Scientific Title of Study   Evaluation of Dermatological Safety of Test Products, Positive and Negative Controls by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NB210006-NB Version 01 Date 18Nov2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel 
Designation  Medical Director Principal Investigator 
Affiliation  NovoBliss Research Private Limited 
Address  Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj Gandhinagar

Gandhinagar
GUJARAT
382421
India 
Phone  91-079-48983895  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Medical Director Principal Investigator 
Affiliation  NovoBliss Research Private Limited 
Address  Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj Gandhinagar


GUJARAT
382421
India 
Phone  91-079-48983895  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Public Query  
Name  Maheshvari Patel 
Designation  Director Operations and Strategic Management 
Affiliation  NovoBliss Research Private Limited 
Address  Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj Gandhinagar

Gandhinagar
GUJARAT
382421
India 
Phone  91-079-48983895  
Fax    
Email  maheshvari@novobliss.in  
 
Source of Monetary or Material Support  
NovoBliss Research Private Limited Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj Gandhinagar 382421 Gujarat India 
 
Primary Sponsor  
Name  NovoBliss Research Private Limited 
Address  Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj Gandhinagar 382421 Gujarat India 
Type of Sponsor  Contract research organization 
 
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 
Maheshvari Patel  NovoBliss Research Private Limited  Office A 206 2nd Floor Clinical Trials Department Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj Gandhinagar
Gandhinagar
GUJARAT 		 91-9909013236

maheshvari@novobliss.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACEAS – Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Adult Human Subjects with Intact Skin on Back 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cosmetic Marketed Cream, Cosmetic Marketed Skin Moisturising Lotion  At 30 mins, 24 hours and 168 hours post patch removal 
Comparator Agent  Positive Control-Sodium Lauryal Sulphate 1%w/v SLS solution, 3%w/v SLS Solution Negative Control-0.9% w/v N Saline  At 30 mins, 24 hours and 168 hours post patch removal 
 
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 number of males and females).
3. Subject with normal Fitzpatrick skin type III to V (human skin colour determination scale).
4. Females of childbearing potential must have a self-reported negative urine pregnancy test before patch application.
5. Subjects who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
6. The subject is in good general health as determined by the Investigator on the basis of medical history.
7. Subjects is willing to maintain the test patches in designated positions for 24 Hours.
8. Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
9. Subject must be able to understand and provide written informed consent to participate in the study.
10.The subject is willing to refrain from vigorous physical exercise during the study period and follow all the instructions given  
 
ExclusionCriteria 
Details  1. A subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos (within the previous 3 months), 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 that may affect skin response and/or past medical history.
3. A subject having a history of diabetes
4. The subject has a 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. A subject suffering from any active clinically significant skin diseases which may contraindicate.
6. A subject has a 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. A subject has a history of asthma or COPD (Chronic obstructive pulmonary disease).
9. 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 weeks of test product application (steroidal nose drops and/or eye drops are permitted)
10. Topical drugs used at the application site.
11. Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematosus.
12. An 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.
13. Subject with known allergy or sensitization to medical adhesives, bandages.
14. Participation in other patch studies simultaneously  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The objective of this validation study is to evaluate the standardize the methods, procedural steps, validate the controls and evaluations techniques that are used during the conduct of Primary Irritation Patch Test (PIPT) studies at by NovoBliss Research by 24 Hours Patch Test Under Complete Occlusion on healthy adult human subjects and adequate representation of varied skin types (Oily, Dry, Normal and Combination).  At 30 mins, 24 hours and 168 hours post-patch removal  
 
Secondary Outcome  
Outcome  TimePoints 
Safety of the Subjects  Irritation Scoring at 30 mins, 24 hours and 168 hours post-patch removal 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/12/2021 
Date of Study Completion (India) 23/12/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Under Editors Review 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Standardization is the process of implementing and developing technical standards based on the consensus of different users, evaluators, performers. Standardization can help to maximize compatibility, interoperability/interevaluator, safety, repeatability, and quality. 

It can also facilitate the commoditization of formerly custom processes. The process of standardization can itself be standardized. This validation study report describes the standardization process for Patch Testing Studies. By the implementation of this standardization and validation, we have maximized our quality of performing patch testing studies for all types of dermal products inclusive of Cosmetics, Personal Care Products, Pharmaceuticals Drugs, topical products, baby care products, mother care products, etc. 


The objective of this validation study was to standardize the methods, procedural steps and validate the positive and negative controls and evaluations techniques that are used during the conduct of Primary Irritation Patch Test (PIPT) by 24 Hours Patch Test Under Complete Occlusion or any patch testing studies {i.e., Cumulative Irritation Patch Testing (CIPT), Human Repeat Insult Patch Testing (HRIPT), Phototoxicity and Photo allergy Studies} conducted at/by NovoBliss Research as per study design on healthy adult human subjects and adequate representation of varied skin types (Oily, Dry, Normal and Combination). This standardization and validation study was also for establishing documentary evidence demonstrating that procedural steps, processes, and clinical activities carried out in patch testing for Dermal Safety Studies to maintains the desired level of compliance and consistency.

Overall Conclusion:

No complaints of adverse effects or worsening of skin conditions were reported on a single application of the product during and till the completion of the study.

At the end of the study, we can conclude that both the concentration of the positive control i.e.  1% w/v and 3% w/v SLS solution showed a high irritancy level at Visit 3 (Day 3) as compared to another test article, negative control. As per PCD 19: Cosmetics [third revision and IS 4011:2018 Methods of Test for Safety Evaluation of Cosmetics] and CHD 25: Soaps and Other Surface-Active Agents Sectional Committee [first revision and IS 13424:2001 Safety evaluation of bathing bars and toilet soaps] the results of negative and positive controls were meet the criteria. From this standardization and validation study. We conclude to have set a benchmark for patch testing studies that produce consistent, compatible, accurate, qualitative, and reproducible results, controlled testing methods of patch testing.

 
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