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CTRI Number  CTRI/2022/11/047452 [Registered on: 21/11/2022] Trial Registered Prospectively
Last Modified On: 09/12/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetic]  
Study Design  Other 
Public Title of Study   To study the safety on test products on skin. 
Scientific Title of Study   Evaluation of Skin Safety of test products using 24 Hours Patch Test on Adult Healthy Human Participants with Sensitive Skin.  IS 4011:2018 Guidelines. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CL/113/1022/STU Version No.: 1 of 21 st October 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajiv Joshi 
Designation  Principal Investigator 
Affiliation  C.L.A.I.M.S. PVT. LTD. 
Address  Room No: 103, 1st Floor,Shiv Krupa, S.R.A. CHS Ltd, C Wing, Panam Park, Off Sahar Road, Vile Parle East

Mumbai
MAHARASHTRA
400 057
India 
Phone    
Fax    
Email  rsjdrs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ruchi Srivastava 
Designation  Principal Scientist – Medical Affairs & Clinical Research  
Affiliation  Dabur India Limited 
Address  Dabur Research & Development Centre. Plot No.22, Site IV, Sahibabad Ghaziabad India

Ghaziabad
UTTAR PRADESH
201010
India 
Phone    
Fax    
Email  ruchi.srivastava@dabur.com  
 
Details of Contact Person
Public Query  
Name  Dr Sasi Bhushan Vedula 
Designation  Senior Manager – Medical Affairs & Clinical Research 
Affiliation  Dabur India Limited 
Address  Dabur Research & Development Centre. Plot No.22, Site IV, Sahibabad Ghaziabad India

Ghaziabad
UTTAR PRADESH
201010
India 
Phone    
Fax    
Email  sasibhushan.vedula@dabur.com  
 
Source of Monetary or Material Support  
Dabur Research & Development Centre 
 
Primary Sponsor  
Name  Dabur Research and Development Centre 
Address  Plot No.22, Site IV, Sahibabad-201010, Ghaziabad (U.P.), India. 
Type of Sponsor  Other [Ayurvedic and Natural Healthcare ] 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajiv Joshi  C.L.A.I.M.S. PVT. LTD.  Shiv Krupa, S.R.A. CHS Ltd, C Wing, Room No: 103, 1st Floor, Panam Park, Off Sahar Road, Vile Parle East
Mumbai
MAHARASHTRA 		 66758851

rsjdrs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human volunteers with sensitive skin will be included in the study 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Licefix  Filter papers dipped in test products (to contain approximately 0.04 ml of solution) will be filled in well of patch chamber and applied occlusively on back/upper arm of participant. The patch was applied occlusively, on the back of participants at 0 hour. Duration of occlusion was 24 hours. 
Comparator Agent  Negative Control - 0.9% isotonic saline solution  Filter papers dipped in negative control - 0.9% isotonic saline solution (to contain approximately 0.04 ml of solutions) will be filled in different wells of patch chambers and applied on test sites on back/upper arm of participant. Then it will be occluded. Patches will be secured using micropore tape. Duration of occlusion will be 24 hours. 
Comparator Agent  Positive control - 1% w/w SLS solution  Filter papers dipped in positive control - 1% w/w SLS solution (to contain approximately 0.04 ml of solutions) will be filled in different wells of patch chambers and applied on test sites on back/upper arm of participant. Then it will be occluded. Patches will be secured using micropore tape. Duration of occlusion will be 24 hours. 
Intervention  VATIKA DERMOVIVA-FACE MASK  Approximately 0.04g of test product will be applied on the back of participant with the help of spatula and left for drying. After few minutes it will be semi-occluded. The patch will be applied on the back of participants at 0 hour.Patches will be secured using micropore tape. Duration of occlusion will be 24 hours. 
Intervention  VATIKA DERMOVIVA-FACE SCRUB  8% w/w dilution of test products will be prepared in distilled water. Filter papers dipped in diluted test products and will be filled in different wells of patch chambers. The patch will be applied occlusively, on the back of participants at 0 hour. Duration of occlusion will be 24 hours. 
Intervention  VATIKA DERMOVIVA-FACE WASH  8% w/w dilution of test products will be prepared in distilled water. Filter papers dipped in diluted test products and will be filled in different wells of patch chambers. The patch will be applied occlusively, on the back of participants at 0 hour. Duration of occlusion will be 24 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  a) Voluntary men and women (preferably equal number of males and females) between 18
and 65 years having sensitive skin in nasolabial area as determined by lactic acid sting
test @ .
b) Fitzpatrick skin type III to IV.
c) Having apparently healthy skin on test area.
d) Willingness to discontinue the use of cleansing and/or cosmetic products in the application
areas during the course of the trial.
e) Cooperating, informed of the need and duration of the examinations, and ready to comply
with protocol procedures.
f) Willing to give written informed consent to participate in the trial after informing all
information concerning the trial procedures and trial objectives.
g) Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the
course of the trial.
h) Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.:
exercise, sauna…), during the course of the trial.

Protocol No.: CL/113/1022/STU - Version No.: 1 of 21 st October 2022 Page 11 of 17
i) Should be able to read and write (in English, Hindi, or local language).
j) Ready to wear loose cotton clothes
k) Having valid proof of identity and age.
l) Subject having not participated in another trial in the past one month. 
 
ExclusionCriteria 
Details  a) Pregnancy (by UPT) and lactating women.
b) Scars, excessive terminal hair, tattoo, cuts, wounds, irritation symptoms, abrasion, or any
other skin condition on the studied area.
c) Athletes and subjects with history of excessive sweating.
d) Subjects on oral corticosteroid.
e) Any history of underlying uncontrolled medical illness including diabetes, liver disease or
history of alcoholism, HIV, or any other serious medical illness.
f) A participant who the Investigator feels will not be compliant with trial requirements
g) Dermatological infection/pathology on the level of studied area.
h) Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
i) Any clinically significant systemic or cutaneous disease, which may interfere with trial
procedures.
j) Chronic illness which may influence the outcome of the trial.
k) Participants on any medical treatment either systemic or topical which may interfere with
the performance of the trial (presently or in the past 1 month).
l) Participant in an exclusion period or participating in another food, cosmetic or therapeutic
trial. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Evaluation of cutaneous tolerance of skin reactions.  48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/11/2022 
Date of Study Completion (India) 05/12/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
Patch test - This test is performed to assess the dermal safety of test products involved in the
trial. It is a technique used to determine the potential of specific substances to cause irritancy
of the skin. Irritants are substances that damage the skin by direct toxic action. The damage
will depend upon the nature of the irritant, its concentration, and duration of exposure.

Protocol No.: CL/113/1022/STU - Version No.: 1 of 21 st October 2022 Page 7 of 17
Irritation is manifested as inflammatory responses such as erythema (redness), oedema
(swelling), vesiculation and finally to an intense suppurative reaction without the involvement
of 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. Reactions such as erythema, dryness and wrinkling are then scored.


The study was completed with 26 complete cases and there were no adverse events.
 
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