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CTRI Number  CTRI/2020/05/025311 [Registered on: 22/05/2020] Trial Registered Prospectively
Last Modified On: 18/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetics]  
Study Design  Single Arm Study 
Public Title of Study   Primary Irritation Patch Test on Humans with Normal Skin Type 
Scientific Title of Study   To Evaluate Dermatological Safety of Investigational Products by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Subjects With Normal Skin Type 
Trial Acronym  SAFE/DAPT/2020-01 
Secondary IDs if Any  
Secondary ID  Identifier 
SAFE/DAPT/2020-01, Version: 1.0,07 May 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukesh Ramnane 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt. Ltd  
Address  Ground floor, Sensitivity Room, MS Clinical Research Pvt Ltd, 327/15, 1st Main Road, Cambridge Layout, Ulsoor,

Bangalore
KARNATAKA
560008
India 
Phone  8040917253  
Fax  8040917253  
Email  mukesh.ramnane@mscr.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Gupta  
Designation  Head Medical Affairs & Clinical Research  
Affiliation  Dabur India Limited  
Address  Department of Medical Affairs & Clinical Research,First Floor, Dabur Research & Development Centre Dabur India Ltd Plot No.22, Site IV, Sahibabad

Ghaziabad
UTTAR PRADESH
201010
India 
Phone  01203378614   
Fax  01204552645  
Email  arun.gupta@dabur.com  
 
Details of Contact Person
Public Query  
Name  Ritambhara  
Designation  Director- Business & Operations  
Affiliation  MS Clinical Research Pvt. Ltd  
Address  Ground floor, Sensitivity Room, MS Clinical Research Pvt Ltd, 327/15, 1st Main Road, Cambridge Layout, Ulsoor,

Bangalore
KARNATAKA
560008
India 
Phone  8040917253  
Fax  8040917253  
Email  ritambhara@mscr.in  
 
Source of Monetary or Material Support  
Dabur India Limited,Plot Number 22, Site IV, Sahibabad, Ghaziabad, U.P.- 201010 
 
Primary Sponsor  
Name  Dabur India Limited 
Address  Dabur Research & Development Centre Dabur India Ltd Plot No.22 Site IV Sahibabad, Ghaziabad Uttar Pradesh India 
Type of Sponsor  Other [Other [Healthcare & FMCG] ] 
 
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 Mukesh Ramnane  MS Clinical Reserch Pvt Ltd   Ground floor, Sensitivity Room, MS Clinical Research Pvt Ltd, 327/15, 1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA 		 8040917253
8040917253
mukesh.ramnane@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 Human Volunteers with Normal Skin Type 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Dabur Baby Shampoo 2. Dabur Baby-Baby Wash 3. Dabur Baby-Baby Lotion 4. Dabur Baby-Cream 5. Dabur Baby-Baby Wipes 6. Dabur Baby-Baby Powder (Talc) 7. Dabur Baby-Baby Powder (Starch) 8. Dabur Baby-Baby Soap 9. Dabur Baby-Massage oil  Products will be evaluated through complete occlusion application for 24 hrs. After patch removal, skin will be observed for irritation reactions at 0 hr, 24 hr, 48 hr and 7 days 
Comparator Agent  1. Positive control 1- 1% SLS 2. Positive control 2- 3% SLS 3. Negative control- Normal Saline   Products will be evaluated through complete occlusion application for 24 hrs. After patch removal, skin will be observed for irritation reactions at 0 hr, 24 hr, 48 hr and 7 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Healthy male and female subjects (1:1 ratio) in the age group of 18-65 years (both age
inclusive).
2. Subjects with normal skin
3. Subjects with Fitzpatrick skin type III to V.
4. Female subjects with child bearing potential willing to undergo Urine Pregnancy Test.
5. Subjects free from excessive hair, cuts, wounds, irritation symptoms, abrasion or any
other skin condition which may interfere in the study results.
6. Subjects willing to give a voluntary written informed consent.
7. Subjects willing to maintain the patch test in position for 24 hours.
8. Subject having not participated in a similar investigation in the past two weeks.
9. Subjects willing to come for regular follow up visits.
10. Subjects ready to follow instructions during the study period.
11. Subjects willing to avoid UV exposure (sun or artificial UV) on test site during the course of study.
12. Subjects willing to avoid excessive water contact (e.g. swimming) or activity which
causes excessive sweating (like exercises, sauna etc.) during the course of study.
13. Subjects should have healthy skin on test area.
14. Subjects having valid proof of identity and age. 
 
ExclusionCriteria 
Details  1. Infection, allergy on the tested area.
2. Skin allergy antecedents or atopic subjects.
3. Subjects with known hypersensitivity to any of the study products or constituents.
4. Subjects with any significant skin pathology in the investigational area
5. Athletes and subjects with history of excessive sweating.
6. Cutaneous disease which may influence the study result.
7. Subjects using any topical or systemic treatment that could interfere with the study
treatments/assessments within the last 4 weeks prior to participation in the study and during the
study.
8. Subjects on oral corticosteroid.
9. Subjects participating in any other cosmetic or therapeutic study.
10. Female subjects who are pregnant or lactating.
11. 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   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluation of Dermatological Safety of Investigational Products By 24 Hours Patch Test Under Complete Occlusion on Adult Healthy Human Subjects with Normal skin   0 hr, 24 hr, 48 hr & 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/05/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="9" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Results of the study of this clinical study may be used for publishing scientific papers and data. All the data generated on the trial will be exclusive property of sponsor; and no publication can be done without sponsor written approval. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The participants will be selected from a volunteer panel with normal skin at the study site. Twenty Four (male and female, in equal ratio) adult subjects in the age group of 18 years to 65 years with normal skin types will be selected according to inclusion and exclusion criteria. Assessment of the irritation potential of investigational products in comparison to positive and negative control will be done using Draize’s scale of each product at different time points (0 hr, 24 hrs, 48 hrs and day 7 after patch removal). 
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