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CTRI Number  CTRI/2021/04/033202 [Registered on: 28/04/2021] Trial Registered Prospectively
Last Modified On: 18/06/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   To check the safety of 3 test product for skin irritation 
Scientific Title of Study   Evaluation of skin safety of 3 test products for Primary Skin Irritation Using Skin Irritation Test (Patch Test in Humans). IS 4011:2018 Guidelines. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CL/108/0221/STU Version No: 1 of 26th March 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajiv Joshi 
Designation  Dermatologist / Principal Investigator 
Affiliation  C.L.A.I.M.S. PVT. LTD (Clinical Aesthetics & Investigative Management Service) 
Address  Shiv Krupa, S.R.A. CHS Ltd, C Wing, Room No: 103, 1st Floor, Panam Park, Off Sahar Road, Vile Parle East, Mumbai

Mumbai
MAHARASHTRA
400057
India 
Phone  02266758851  
Fax    
Email  rsjdrs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dipesh Sonawane 
Designation  Sr. Manager - Medical Services 
Affiliation  Lupin Ltd. 
Address  Kalpataru Inspire Bldg., Opp Hotel Grand Hyatt, Santacruz-East Mumbai

Mumbai
MAHARASHTRA
400055
India 
Phone  07071570717  
Fax    
Email  dipeshsonawane@lupin.com  
 
Details of Contact Person
Public Query  
Name  Dr Dipesh Sonawane 
Designation  Sr. Manager - Medical Services 
Affiliation  Lupin Ltd. 
Address  Kalpataru Inspire Bldg., Opp Hotel Grand Hyatt, Santacruz-East Mumbai

Osmanabad
MAHARASHTRA
400055
India 
Phone  07071570717  
Fax    
Email  dipeshsonawane@lupin.com  
 
Source of Monetary or Material Support  
Lupin Ltd. 3rd Floor, Kalpataru Inspire, Off. Western Expressway Highway, Santacruz (East), Mumbai 400 055, India 
 
Primary Sponsor  
Name  Lupin Ltd 
Address  3rd Floor, Kalpataru Inspire, Off. Western Expressway Highway, Santacruz (East), Mumbai 400 055, India 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 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 400 057
Mumbai
MAHARASHTRA 		 02266758851

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 skin on test area 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.9% Isotonic Saline- Negative Control   0.04 ml of negative control will be filled in wells of the patch chambers. Then it will be occluded. Duration of occlusion will be 24 hours. 
Comparator Agent  1% Sodium Lauryl sulphate-Positive Control  0.04 ml of positive control will be filled in wells of the patch chambers. Then it will be occluded. Duration of occlusion will be 24 hours. 
Intervention  AB Next Gel  0.04 gm of test product will be filled in wells of the patch chambers. Then it will be occluded. Duration of occlusion will be 24 hours.  
Comparator Agent  Deriva BPO Gel  0.04 gm of comparator product will be filled in wells of the patch chambers. Then it will be occluded. Duration of occlusion will be 24 hours. 
Comparator Agent  Epiduo Gel  0.04 gm of comparator product will be filled in wells of the patch chambers. Then it will be occluded. Duration of occlusion will be 24 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Fitzpatrick skin type III to IV.

Having apparently healthy skin on test area.

Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study. 
 
ExclusionCriteria 
Details  Pregnancy (by history) and lactating women.

Scars, excessive terminal hair or tattoo on the studied area.

Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Evaluation of cutaneous tolerance by dermatological scoring of skin reactions using Draize scale.

Evaluation of erythema using spectrophotometer (a value) 		 48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/05/2021 
Date of Study Completion (India) 04/06/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
The test products,

    -  AB NEXT Gel - B No.: AB20003
    -  Epiduo Gel - B No.: GU26
    -  Deriva BPO Gel - B No.: 10200454

were dermatologically tested and found to be “Non-Irritant” based on IS 4011:2018 Methods of Test for safety evaluation of cosmetics - Third Revision.

Based on a* values,
Erythema developed due to AB NEXT Gel was significantly lower as compared to erythema developed due to Epiduo Gel and Deriva BPO Gel.
     
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