| CTRI Number | CTRI/2011/12/002246 [Registered on: 16/12/2011] Trial Registered Retrospectively | 
    | Last Modified On: | 26/12/2012 | 
	
    | Post Graduate Thesis | No | 
    | Type of Trial | Interventional | 
    | Type of Study | Other (Specify) [Skin sensitisation study] | 
    | Study Design | Other | 
    | Public Title of Study | Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers | 
    | Scientific Title of Study | Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers | 
    | Trial Acronym |  | 
    | Secondary IDs if Any | 
    
        | Secondary ID | Identifier |  
            | NIL | NIL |  | 
    | Details of Principal Investigator or overall Trial Coordinator (multi-center study) | 
        
            | Name | Dr Mukta Sachdev |  
            | Designation | Principal Investigator |  
            | Affiliation | MS Clinical Research Pvt. Ltd |  
            | Address | Mezzanine floor, Classic court,
9/1 Richmond Road, Bangalore 
 Bangalore
 KARNATAKA
 560025
 India
 |  
            | Phone | 80-91-40917253 |  
            | Fax | 80-91-41125934 |  
            | Email | mukta.sachdev@mscr.in |  | 
    | Details of Contact Person Scientific Query
 | 
        
            | Name | Dr Mukta Sachdev |  
            | Designation | Principal Investigator |  
            | Affiliation | MS Clinical Research Pvt. Ltd |  
            | Address | Mezzanine floor, Classic court,
9/1 Richmond Road, Bangalore 
 
 KARNATAKA
 560025
 India
 |  
            | Phone | 80-91-40917253 |  
            | Fax | 80-91-41125934 |  
            | Email | mukta.sachdev@mscr.in |  | 
    | Details of Contact Person Public Query
 | 
        
            | Name | Dr Mukta Sachdev |  
            | Designation | Principal Investigator |  
            | Affiliation | MS Clinical Research Pvt. Ltd |  
            | Address | Mezzanine floor, Classic court,
9/1 Richmond Road, Bangalore 
 
 KARNATAKA
 560025
 India
 |  
            | Phone | 80-91-40917253 |  
            | Fax | 80-91-41125934 |  
            | Email | mukta.sachdev@mscr.in |  | 
    | Source of Monetary or Material Support |  | 
    | Primary Sponsor | 
        
            | Name | ITC RD Centre |  
            | Address | Peenya Industrial area, I Phase, Peenya Bangalore- 560058 Karnataka, India |  
            | Type of Sponsor | Other [FMCG Company] |  | 
    | Details of Secondary Sponsor |  | 
    | Countries of Recruitment | India | 
    | Sites of Study | 
    
           | No of Sites = 1 |  
        | Name of Principal
Investigator | Name of Site | Site Address | Phone/Fax/Email |  
        | Dr Mukta Sachdev | MS Clinical Research Pvt. Ltd | Mezzanine floor, Classic court, 9/1 Richmond Road,
Bangalore Bangalore
 KARNATAKA
 | 80-91-40917253 80-91-41125934
 mukta.sachdev@mscr.in
 |  | 
    | Details of Ethics Committee | 
    
           | No of Ethics Committees= 1 |  
                | Name of Committee | Approval Status |  
                | Clinicom | Approved |  | 
    | Regulatory Clearance Status from DCGI |  | 
    | Health Condition / Problems Studied | 
            
                | Health Type | Condition |  
    		| Healthy Human Volunteers | Normal Condition |  | 
    | Intervention / Comparator Agent | 
            
                | Type | Name | Details |  
    | Intervention | 3% Sodium Lauryl Suplhate solution | The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |  
    | Intervention | Face Wash – 014-011-B | The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |  
    | Intervention | FDW Aqua Vitalize Soap – TSP 55- 146 | The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |  
    | Comparator Agent | Not Applicable | Not Applicable |  
    | Intervention | Speria natural glow soap – TSP 55- 029 A | The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |  
    | Intervention | Vivel 3 in 1 facewash +scrub- #3843 | The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |  
    | Intervention | Vivel GMO Soap – TSP 50-133 | The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |  
    | Intervention | vivel young Glow Soap –TSP 50-134 | The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |  | 
    | Inclusion Criteria | 
            
                | Age From | 18.00 Year(s) |  
                | Age To | 55.00 Year(s) |  
                | Gender | Both |  
                | Details | � Subjects age group 18 - 55 years � Healthy male & female volunteers
 � Subjects with skin type III to V.
 � Subjects willing to give a written informed consent.
 � Subjects willing to maintain the patch test in position for 24 hours
 � Subject has not participated in a similar investigation in the past two weeks.
 � Subjects willing to come for regular follow up.
 � Subjects ready to follow instructions during the study period.
 |  | 
    | ExclusionCriteria | 
	            
            
                               
            
                | Details | � Infection, allergy on the tested area � Skin allergy antecedents or atopic subjects
 � Hyper sensitivity to any component of the tested products
 � Athletes and subjects with history of excessive sweating
 � Cutaneous disease which may influence the study result
 � Chronic illness which may influence the cutaneous state.
 � Subjects on oral corticosteroid with dose 10mg/day
 � Subjects participating in any other cosmetic or therapeutic trial.
 � Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
 |  | 
    | Method of Generating Random Sequence | Not Applicable | 
    | Method of Concealment | Other | 
    | Blinding/Masking | Not Applicable | 
    | Primary Outcome | 
             
                | Outcome | TimePoints |  
                | The objective of this study is to evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by dermatological visual assessment. | 24HRS, 48HRS, 1 WEEK |  | 
    | 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)= ""
 Final Enrollment numbers achieved (India)=""
 | 
    | Phase of Trial | N/A | 
    | Date of First Enrollment (India) | 02/11/2011 | 
	
| Date of Study Completion (India) | Date Missing | 
    | 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 | Not Apllicable | 
	
| Individual Participant Data (IPD) Sharing Statement | 
    
        Will individual participant data (IPD) be shared publicly (including data dictionaries)?   | 
    | Brief Summary | . Objective:   The
 objective of this study is to evaluate the dermatological safety of the
 given investigational product/s on skin of healthy human volunteers.    Product/s will be evaluated by carrying out patch test under occlusion for 24 hours.   .  Subject Population:   24 healthy human volunteers (Male and Female 1:1) Skin types (Oily, Dry, Normal and Combination, 1:1:1:1 ratio).   Duration of study:              5 visits (9 days for each volunteers)   7.  Inclusion / Exclusion Criteria:       7.1 Inclusion Criteria: �         Subjects age group 18 - 55 years �         Healthy male & female volunteers  �         Subjects with skin type III to V. �         Subjects willing to give a written informed consent. �         Subjects willing to maintain the patch test in position for  24 hours �         Subject has not participated in a similar investigation in the past two weeks. �         Subjects willing to come for regular follow up. �         Subjects ready to follow instructions during the study period.   7.2  Exclusion Criteria: �         Infection, allergy on the tested area �         Skin allergy antecedents or atopic subjects �         Hyper sensitivity to any component of the tested products �         Athletes and subjects with history of excessive sweating �         Cutaneous disease which may influence the study result  �         Chronic illness which may influence the cutaneous state. �         Subjects on oral corticosteroid with dose >10mg/day �         Subjects participating in any other cosmetic or therapeutic trial. �         Any
 history of underlying uncontrolled medical illness including diabetes, 
liver disease or history of alcoholism, HIV or any other serious medical
 illness.  |