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CTRI Number  CTRI/2022/04/041621 [Registered on: 04/04/2022] Trial Registered Prospectively
Last Modified On: 02/12/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Skin Sensitivity test]  
Study Design  Other 
Public Title of Study   To check the safety of the products 
Scientific Title of Study   Evaluation of skin sensitization potential of investigational products by Human Repeat Insult Patch Test (HRIPT) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SAFE/MAHR/2022-04 Version 1.0 Dated 08 Mar 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vidya Kuntoji 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Ground floor, Sensitivity room no. 1, 327/15, 1st Main Road Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  vidya@mscr.in  
 
Details of Contact Person
Scientific Query  
Name  Ritambhara 
Designation  Director- Business and Operation 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Room no.2, Ground floor,327/15, 1st Main Road Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  ritambhara@mscr.in  
 
Details of Contact Person
Public Query  
Name  Sudhanthiran S 
Designation  Study Manager 
Affiliation  MS Clinical Research Pvt Ltd 
Address  First Floor, Room no. 1, Councelling Area, 327/15, 1st main road, cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  sudhan@mscr.in  
 
Source of Monetary or Material Support  
Marico Limited Marks, plot no:23-C Mahal, Industrial Estate Mahakali Caves Road, Andheri(E), Mumbai 400093 
 
Primary Sponsor  
Name  Marico Limited 
Address  Marks, plot no:23-C Mahal, Industrial Estate Mahakali Caves Road, Andheri(E), Mumbai 400093 
Type of Sponsor  Other [FMCG(Fast moving Consumer Goods)] 
 
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 Vidya Kuntoji  MS Clinical Research Pvt. Ltd.  Ground floor, Sensitivity room No. 1 ,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA 		 08041125934
08040917253
vidya@mscr.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinicom Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Male and Female subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1.RM.M480.67  40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 3 weeks for each subject  
Comparator Agent  10.9.Negative control (0.9N Saline)  40 µl of 0.9N saline will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 3 weeks for each subject  
Intervention  2.RM.M480.77  40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 3 weeks for each subject 
Intervention  3.RM.M480.74  40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 3 weeks for each subject 
Intervention  4.RM.M480.76  40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 3 weeks for each subject 
Intervention  5.RM.M480.70  40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 3 weeks for each subject 
Intervention  6.RM.M480.81  40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 3 weeks for each subject 
Intervention  7.RM.M480.85  40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 3 weeks for each subject 
Intervention  8.RM.M480.86  40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 3 weeks for each subject 
Intervention  9.GN 22  40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 3 weeks for each subject 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or female subjects 18 to 65 years of age
2. Subjects must be generally in good health as determined from a recent medical history which is on file with the investigator.
3. The ability of the subject to understand and sign a written informed consent form which must be obtained prior to treatment.
4. Subjects with skin type (Normal: Oily: Combination: Dry in the ratio of 1:1:1:1), and sensitive skin (dry sensitive skin: normal sensitive skin in the ration 1:1)
5. Willingness to avoid UV exposure (sun or artificial UV) on the test sites during the course of the study.
6. Subjects must have clear back. They should not have any infection or allergy on the tested area. They should have healthy skin on test area
7. Subjects should be cooperative, informed of the need and duration of the examination and ready to comply with the protocol procedures
8. Subjects having valid proof of identity and age.
9. Willingness to avoid excessive water contact (like swimming etc.) or activity
which causes excessive sweating (like exercise, sauna, etc.) during the course of study
10. Subjects with skin photo type III to V 
 
ExclusionCriteria 
Details  1. Pregnant women/ Nursing mothers
2. Scars excessive terminal hair or tattoo on the studied area.
3. Henna tattoo anywhere on the body (in case of studies involving hair dyes).
4. Dermatological infection/pathology on the level of studied area
5. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye)
6. Any clinically significant systematic or cutaneous disease, which may interfere with study treatment or procedures
7. Chronic illness which may influence the outcome of the study.
8. Subject on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month)
9. Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
10. Subjects having mole or hair on the back which may influence the study results as per the investigator and study coordinator decision 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the dermatological safety of the investigational products on healthy human subjects  Approximately 6 weeks for each subject  
 
Secondary Outcome  
Outcome  TimePoints 
None  NA 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/04/2022 
Date of Study Completion (India) 27/05/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Study will be conducted to assess the safety of the test products. After consenting and qualifying the inclusion and exclusion criteria subjects will be enrolled into the study. For the selected subjects, the patch will be applied alternate days for 3 weeks. The assessment will be perfoemed for every 48 hrs once the patch is applied. Then there will be a rest phase of 2 weeks and then the patch will be applied and assessed for 72 hrs. 
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