FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/03/105579 [Registered on: 06/03/2026] Trial Registered Prospectively
Last Modified On: 09/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Primary irritation patch testing]  
Study Design  Single Arm Study 
Public Title of Study   Safety evaluation of products on skin 
Scientific Title of Study   Dermatological Safety Assessment of Test Products Using Primary Irritation Patch Test (PIPT) in Healthy Adult Human Subjects 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NB260018-DI, Version 1.0, 12 Jun 25  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 Private Limited 
Address  NovoBliss Research Pvt. Ltd. Office 313, Silver Radiance - 4, Gota, Ahmedabad - 382481, Gujarat, India Ahmadabad

Ahmadabad
GUJARAT
382481
India 
Phone  07948983895  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Principal Investigator- Medical Director 
Affiliation  NovoBliss Research Private Limited 
Address  NovoBliss Research Pvt. Ltd. Office 313, Silver Radiance - 4, Gota, Ahmedabad - 382481, Gujarat, India Ahmadabad


GUJARAT
382481
India 
Phone  07948983895  
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 - 382481, Gujarat, India Ahmadabad

Ahmadabad
GUJARAT
382481
India 
Phone  07948983895  
Fax    
Email  maheshvari@novobliss.in  
 
Source of Monetary or Material Support  
Dabur India Limited, Dabur Research and Development Center 22, Site 4, Sahibabad Industrial Area, Ghaziabad, Uttar Pradesh-201010  
 
Primary Sponsor  
Name  Dabur India Limited 
Address  Dabur Research & Development Center 22, Site 4, Sahibabad Industrial Area, Ghaziabad, Uttar Pradesh-201010 
Type of Sponsor  Other [Personal care and hygiene manufacturer] 
 
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  NovoBliss Research Private Limited  Office 313, Silver Radiance - 4, Gota, Ahmedabad - 382481, Gujarat,India
Ahmadabad
GUJARAT 		 07948983895

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  Healthy Participants with varied skin type 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Odomos Baby Mosquito Repellent Fabric Roll-On  Route of administration: Topical mode of usage: Products will be applied to subjects on fabric for 24 hours. At 24hours post-application, skin will be assessed for irritation reactions at 30 mins, 24hours (Day1) post patch application and 168hours(Day 7) if needed).Frequency: single application Duration:09 Days 
Intervention  Odomos Baby Mosquito Repellent Patches  Route of administration: Topical mode of usage: Products will be applied to subjects on fabric for 24 hours. At 24hours post-application, skin will be assessed for irritation reactions at 30 mins, 24hours (Day1) post patch application and 168hours(Day 7) if needed).Frequency: single application Duration:09 Days 
Comparator Agent  Positive Control-1%w/v SLS  Route of administration: Topical mode of usage: Products will be evaluated through the complete occlusionpatchapplication for 24 hours. At 24hours post-application, patches will be removed and skin will be assessed forirritationreactions at 30 mins, 24hours (Day1) post patch removal and 168hours(Day 7) ifneeded).Frequency:single applicationDuration:09 Days 
Comparator Agent  Sodium chloride(IsotonicSaline Solution)InjectionIP0.9% w/v  Route of administration: Topical mode of usage: Products will be evaluated through the complete occlusionpatchapplication for 24 hours. At 24hours post-application, patches will be removed and skin will be assessed forirritationreactions at 30 mins, 24hours (Day1) post patch removal and 168hours(Day 7) ifneeded).Frequency:single applicationDuration: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) Participant with normal Fitzpatrick skin type III to V (Human skin colour
determination scale).
4) Females of childbearing potential must have a self-reported negative
pregnancy test
5) Participant who do not have any previous history of adverse skin conditions
and are not under any medication likely to interfere with the results.
6) Participant is in good general health as determined by the Investigator on the
basis of medical history.
7) Participants is willing to maintain the test patches in designated positions for
24 Hours.
8) Participants is willing and able to follow the study directions, to participate in
the study, returning for all specified visits.
9) Participant must be able to understand and provide written informed consent
to participate in the study.
10) Participant 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:
• Participant scoring greater than 30 for Section 2 – Sensitive v/s Resistant skin
in modified Dr Baumann’s skin type questionnaire.
• Participant with sensitive skin as confirmed by Lactic Acid Stinging Test. 
 
ExclusionCriteria 
Details  1) Participant having skin irritation, blemishes, excessive hair, moles, pigmentation,pimples,marks (e.g. tattoos (within the previous sun burn),open wounds,cuts,abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that careading.
2) Medication which may affect skin response and/or past medical history.
3) Participant having history of diabetes
4) Participant have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of anylast 6 months.
5) Participant suffering from any active clinically significant skin diseases which may contraindicate.
6) Participant 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) Participant 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 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 permitted).
10) Topical drugs used at application site.
11) Participant with Self-reported Immunological disorders such as HIV positive, AIDSand/orsystemic lupus erythematous.
12) Individual who has a medical condition or is taking or has taken a medication which,in theInvestigator’s judgment, makes places thesubjectatundue risk.
13) Participant 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   Other 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the dermatological safety of the test products by 24 Hours Patch Test  After 30 mins, 24 hrs of application 
 
Secondary Outcome  
Outcome  TimePoints 
Safety of the skin  After 30 mins, 24 hrs of application 
 
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)   25/03/2026 
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
Modification(s)  		 This is single-centre, evaluator blinded study in healthy human participants. single 24-hour application of sponsors provided test product along with negative and positive control as per its direction of usage for at least 24 hours (± 2hours). safety will be assessed through the study by monitoring irritation reaction and sufficient number 26 participants will be enrolled to get 24 to complete the study. There are total three visits in this study and one are option(Day01):Screening, Lactic Acid Stinging Test & Modified Dr Baumann’s skin type questionnaire, Enrolment and product Application, Visit 02 After 24 hours of Application & 30 ± 5 min irritation scoring Visit 03(Day 03): 24 (± 2 hour) irritation scoring (Day 0 contacted telephonically on Day 08 for any signs of irritation at product application site. Follow-up visit for reactions if any to confirm recovery if necessary)Irritation scoring at 168 ± 2 hours post-product removal(Day 09). 
Close