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CTRI Number  CTRI/2025/08/093395 [Registered on: 21/08/2025] Trial Registered Prospectively
Last Modified On: 21/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [[Primary Irritation Patch Testing]  
Study Design  Other 
Public Title of Study   Primary Irritation Patch Testing on Healthy Adult Subjects 
Scientific Title of Study   Dermatological Safety Evaluation of Test Product(s) via Primary Irritation Patch Test (PIPT) in Healthy Adult Human Subjects. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NB250033-NY, Version 1.0, 12Jun24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel  
Designation  Principal Investigator - Medical Director 
Affiliation  NovoBliss Research Pvt. Ltd.  
Address  NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481. Ahmadabad GUJARAT 382481 India

Ahmadabad
GUJARAT
382481
India 
Phone  917948983895  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel  
Designation  Principal Investigator - Medical Director 
Affiliation  NovoBliss Research Pvt. Ltd.  
Address  NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481. Ahmadabad GUJARAT 382481 India

Ahmadabad
GUJARAT
382481
India 
Phone  917948983895  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Public Query  
Name  Dr Maheshvari Patel 
Designation  Director Operations and Strategic Management 
Affiliation  NovoBliss Research Pvt. Ltd.  
Address  NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481. Ahmadabad GUJARAT 382481 India

Ahmadabad
GUJARAT
382481
India 
Phone  09909013236  
Fax    
Email  maheshvari@novobliss.in  
 
Source of Monetary or Material Support  
FSN E-Commerce Ventures Limited (NYKAA) 104, Vasan Udyog Bhavan, Sun Mill Compound, Tulsi Pipe Road, Lower Parel, Mumbai, Maharashtra, 400013  
 
Primary Sponsor  
Name  FSN E-Commerce Ventures Limited (NYKAA) 
Address  104, Vasan Udyog Bhavan, Sun Mill Compound, Tulsi Pipe Road, Lower Parel, Mumbai, Maharashtra, 400013 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
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   NovoBliss Research Private Limited   Clinical Trial Department NovoBliss Research Pvt. Ltd. Office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India 382481. Gandhinagar GUJARAT 382421 India Ahmadabad GUJARAT
Ahmadabad
GUJARAT 		 09909013286

dr.nayan@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  Adequate representation of varied skin types  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nykaa Micellar Melter  Dose: 0.04 ml Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 days.  
Comparator Agent  Positive Control- 1% w/v Sodium Lauryl Sulphate (SLS) analytical grade  Dose: 0.04mL Route of administration: Topical mode of usage: Products will be evaluated through the complete occlusion or semi occlusion application for 24 hours. At 24hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins, 24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 Days  
Comparator Agent  sodium chloride (Isotonic Saline Solution) Injection IP 0.9 % w/v   Dose: 0.04mL Route of administration: Topical mode of usage: Products will be evaluated through the complete occlusion or semi occlusion application for 24 hours. At 24hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins, 24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 Days  
 
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 VI (Human skin colour determination scale).
4) Females of childbearing potential must have a self-reported negative pregnancy test.
5) Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
6) 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) Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given.
11) For Sensitive Specific Skin Study Only:
• Subject scoring greater than 30 for Section 2 – Sensitive v/s Resistant skin
in modified Dr Baumann’s skin type questionnaire.
• Subject with sensitive skin as confirmed by Lactic Acid Stinging Test.  
 
ExclusionCriteria 
Details  1) 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 which may affect skin response and/or past medical history.
3) Subject having history of diabetes
4) Subject 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.
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) 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 product application (steroidal nose drops and/or eye drops are permitted)
10) Topical drugs used at application site.
11) Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous.
12) 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 study simultaneously.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the dermatological safety of the
test product by 24 Hours Patch Test Under
Complete Occlusion  		 At 30mins and 24hours post patch removal. At 168hours if needed 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the dermatological safety of the test product   Post patch removal of 30 mins, 24hours & 168 hours  
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="9" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is single-centre, evaluator blinded study in healthy human subjects. single 24-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin for at least 24 hours (± 2hours).safety will be assessed through the study by monitoring of adverse event. A sufficient number 26 subject will be enrolled to get 24 to complete the study. There are total three visits in this study and one are optional visit. Visit 01 (Day01):Screening, Lactic Acid Stinging Test & Modified Dr Baumann’s skin type questionnaire, Enrollment and Patch Application, Visit 02 (Day 02): Patch Removal After 24 hours of Application & 30 ± 5 min irritation scoring upon patch removal Visit 03 (Day 03): 24 (± 2 hour) irritation scoring (Day 03)Visit04: subject will be contacted telephonically on Day 08 for any signs of irritation at patch application site. Follow-up visit for reactions if any to confirm recovery(optional deemed necessary)Irritation scoring at 168 ± 2 hours post-patch removal(Day 09).    
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