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CTRI Number  CTRI/2023/05/053322 [Registered on: 31/05/2023] Trial Registered Prospectively
Last Modified On: 21/09/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetics]  
Study Design  Other 
Public Title of Study   To test the safety of test product by primary irritation patch test on Sensitive Skin 
Scientific Title of Study   Evaluation of Dermatological Safety of Test Product by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Subjects with Sensitive Skin. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
TG/CLI/073b, Version: 1.0, Date: 08 May 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sohandas Shetty 
Designation  Principal Investigator 
Affiliation  TrialGuna Private Limited 
Address  TrialGuna Private Limited #467,1st Main, 4th Cross, Royal County Layout, JP Nagar 8th Phase, 2nd block, Bangalore

Bangalore
KARNATAKA
560083
India 
Phone  8867125414  
Fax    
Email  drsohanshetty@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sasibhushan Vedula 
Designation  Head – Medical Affairs & Clinical Research 
Affiliation  Dabur India Limited 
Address  Dabur India Limited Dabur Research & Development Centre. Plot No.22, Site IV, Sahibabad, Ghaziabad, Uttar Pradesh, India

Ghaziabad
UTTAR PRADESH
201010
India 
Phone    
Fax    
Email  sasibhushan.vedula@dabur.com  
 
Details of Contact Person
Public Query  
Name  Meena Dalal 
Designation  CRO Representative 
Affiliation  TrialGuna Private Limited 
Address  TrialGuna Private Limited #467,1st Main, 4th Cross, Royal County Layout, JP Nagar 8th Phase, 2nd block, Bangalore

Bangalore
KARNATAKA
560083
India 
Phone  9972636265  
Fax    
Email  meena@trialguna.com  
 
Source of Monetary or Material Support  
Dabur Research & Development Centre Plot No.22, Site-IV, Shahibabad-201010 Ghaziabad (U.P.), India 
 
Primary Sponsor  
Name  Dabur India Limited 
Address  Dabur Research & Development Centre, Plot No.22, Site IV, Sahibabad-201010, Ghaziabad (U.P.), India, Tel: (0120) 3378400. 
Type of Sponsor  Research institution 
 
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 Sohandas Shetty  TrialGuna Private Limited  #467,1st Main, 4th Cross, Royal County Layout, JP Nagar 8th Phase, 2nd block, Bangalore-560083
Bangalore
KARNATAKA 		 8867125414

drsohanshetty@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pranav diabetes center ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  negative control - 0.9% isotonic saline solution  Duration: Once for the period of 9 days Route of Administration: Skin Dosage: Quantity Sufficient 
Intervention  Gulabari Organic Rose water  Duration: Once for the period of 9 days Route of Administration: Skin Dosage: Quantity Sufficient 
Intervention  Gulabari Rose water with Aloe vera   Duration: Once for the period of 9 days Route of Administration: Skin Dosage: Quantity Sufficient 
Comparator Agent  positive control - 1% Sodium Lauryl sulphate  Duration: Once for the period of 9 days Route of Administration: Skin Dosage: Quantity Sufficient 
 
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.Subject with normal Fitzpatrick skin type III to V.
4.Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumann’s skin type questionnaire.
5.Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
6.Subject will undergo ‘lactic acid stinging test’ at screening and subject with positive reaction to test will only be enrolled in the study.
7.Subject who does not have any previous history of adverse skin conditions and is not under any medication likely to interfere with the results.
8.The subject is in good general health as determined by the Investigator based on medical history.
9.Subject willing to maintain the test patches in designated positions for 24 Hours.
10.The subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
11.Subject must be able to understand and provide written informed consent to participate in the study.
12.The subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction 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. Subjects 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. Subject with Self-Reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus
erythematous.
10. 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.
11. Subject with known allergy or sensitization to medical adhesives, bandages.
12. Participation in other patch study simultaneously.
13. Use of any:
a. Prescribed or over the counter (OTC) anti-inflammatory drug within five (5) days prior to application.
b. Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch
application.
c. Systemic or topical corticosteroids at patch site within four (4) weeks of test product application (steroidal nose drops and/or eye drops are permitted)
d. Topical drugs used at application site. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Number of subjects that showed No significant irritation.
2. Score of less than or equal to 2 on the Draize scale. 		 Day 1, Day 2, Day 3, Day 9 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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   Phase 4 
Date of First Enrollment (India)   09/06/2023 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Irritants are substances that provoke immediate response in the skin perceived as a superficial skin reaction in terms of erythema, oedema and/or papules. The severity of irritation depends upon the nature, concentration, and duration of exposure. Irritation is manifested as inflammatory responses such as erythema (redness), oedema (swelling), and vesiculation and finally, to an intense supportive reaction without the involvement of the immune system. In general, patches are applied for a contact period of 24 hours, and skin reaction is assessed under a constant artificial daylight source and the marked site is scored post 24 hours after the removal of the patches.The study will be conducted as per IS 4011:2018 Guidelines.
 
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