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CTRI Number  CTRI/2022/06/043289 [Registered on: 15/06/2022] Trial Registered Prospectively
Last Modified On: 29/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetics and Personal Care Products]  
Study Design  Other 
Public Title of Study   Skin Safety study on Healthy human subjects with non-sensitive skin 
Scientific Title of Study   Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NBSP210001-DI-A, Version 01 (Final), 25Oct21  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Apeksha Merja Patel 
Designation  Investigator  
Affiliation  NovoBliss Research Private Limited 
Address  Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj Gandhinagar Gujarat India

Gandhinagar
GUJARAT
382 421
India 
Phone  91-79-48983895   
Fax    
Email  dermatology@novobliss.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sasibhushan Vedula 
Designation  Senior Manager – Medical Affairs & Clinical Research 
Affiliation  Dabur Research and Development Centre, Dabur India Limited 
Address  Dabur Research and Development Centre Dabur India Limited, Plot No. 22, Site-IV, Sahibabad Ghaziabad - 201 010, Uttar Pradesh, India

Ghaziabad
UTTAR PRADESH
201 010
India 
Phone  91-120-3378405  
Fax    
Email  Sasibhushan.vedula@dabur.com  
 
Details of Contact Person
Public Query  
Name  Dr Nayan Patel 
Designation  Medical Director 
Affiliation  NovoBliss Research Private Limited 
Address  Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj Gandhinagar Gujarat India

Gandhinagar
GUJARAT
382421
India 
Phone  09909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Source of Monetary or Material Support  
Dabur India Limited, Dabur Research & Development Centre Dabur India Limited Plot No.22,Site IV Sahibabad, Ghaziabad, Uttar Pradesh-201010  
 
Primary Sponsor  
Name  Dabur India Limited 
Address  Dabur India Limited Dabur Research and Development Centre First Floor, New Wing Plot No.22, Site IV, Sahibabad, Ghaziabad, U.P. 201010 
Type of Sponsor  Other [Healthcare and FMCG] 
 
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 Apeksha Merja Patel  NovoBliss Research Private Limited  Department - Clinical Trials Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj Gandhinagar Gujarat India
Gandhinagar
GUJARAT 		 079-48983895

dermatology@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 non-sensitive skin representation of varied skin types (Oily, Dry, Normal and Combination)  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1) Dabur Vatika Naturals Health Shampoo 2) Dabur Vatika Naturals Black Shine Shampoo 3) Dabur Amla Hair Oil 4) New Dabur Amla Hair Oil 5) Oxylife Sensitive Radiance Creame Bleach 6) Hair Colour Black 7) Hair Colour Dark Brown 8) Odomos Premium Oil 9) Dabur Sarson Amla Hair Oil 10) Dabur Onion Hair Oil 11) Dabur Vatika Select Moroccan Argan Oil Hair Cleansing Bar 12) Dabur Lal Gold Baby Massage Oil  Products will be evaluated through the complete occlusion or open 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). 
Comparator Agent  Negative Control -- Sodium chloride (Isotonic Saline Solution) Injection IP 0.9 % w/v  Products will be evaluated through the complete occlusion or open 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). 
Comparator Agent  Positive Control, Sodium Lauryl Sulphate (SLS) analytical grade 1 % w/v  Products will be evaluated through the complete occlusion or open 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). 
 
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 negative urine pregnancy test performed on Day 01 prior to patch application.
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. The subject is in good general health as determined by the Investigator on the basis of medical history.
7. Subjects are 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. The 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 instructions given. 
 
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   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the dermatological safety of the test
products 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) 		 Irritation Scoring at 30 mins and 24 hours (Day 1) post
patch removal. Scoring can be done at 168
hours (Day 7) post-patch removal if needed. 
 
Secondary Outcome  
Outcome  TimePoints 
Safety of the skin  At 30 mins and 24 hours (Day 1) post
patch removal. Scoring can be done at 168
hours (Day 7) post-patch removal if needed. 
 
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)   20/06/2022 
Date of Study Completion (India) 28/06/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   The results of this clinical study may be used for publishing scientific papers and data. All the data generated on the trial will be the exclusive property of sponsor, and no publication can be done without sponsors written approval. 
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 adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative controls will be kept in contact with the skin of subjects under occlusion for at least 24 hours (+ 2 hours). 
Study can be conducted in multiple groups. Safety will be assessed throughout the study by monitoring of adverse events.  Subject’s back i.e. between the scapula and waist will be utilised as application sites. Application sites will be evaluated for scoring the reaction, namely, erythema, dryness, and wrinkles on a 0-4 point scale separately for each parameter and oedema on another 0-4 points scale as per the Draize Scale after 30+5 minutes of patch removal, 24±2 hours (Day 1) and 168±2 hours (Day 7) after patch removal.  
26 subjects in the age group of 18 to 65 years with varied skin types Oily, Dry, Normal and Combination, preferably equal ratio except for sensitive skin will be selected according to inclusion and exclusion criteria in the study to complete the required numbers i.e. 24 subjects at the end of the study. Preferably with an equal number of males and non-pregnant/non-lactating females.
Score the reaction, namely, erythema, dryness, wrinkles on a 0-4 point scale separately for each parameter and oedema on another 0-4 points scale as per the Draize Scale. 
Four parameters namely erythema, dryness, wrinkles and oedema will be scored separately on irritation scoring sheet, however, the highest score of erythema, dryness and wrinkles will be taken for calculation of Mean Irritation Score (MIS).  Mean Score for Irritation = Total score (highest score from Erythema, dryness, wrinkles + Oedema) for each sample / Total no. of Subjects. The Evaluator/Scorer will be blinded to test product assignments and any previous scores. 
All reasonable attempts will be made to ensure that the same individual will do scoring of all reactions to the test products during the course of the study. If the patch is reinforced with tape, any observed skin irritation that is associated with the tape should be reported separately from that of the patch application area. The combined mean scores and standard deviation of the 24 subjects will be calculated.
 
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