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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  
Not Applicable 
 
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  
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 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  
Status 
Not Applicable 
 
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.

 
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