| CTRI Number |
CTRI/2021/04/033127 [Registered on: 26/04/2021] Trial Registered Prospectively |
| Last Modified On: |
23/04/2021 |
| 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 non-sensitive and sensitive skin |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SAFE/DAPT/2021-06, Version: 1.0, 08 April 2021 |
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 Sasibhushan Vedula |
| Designation |
Senior Manager - Medical Affairs & Clinical Research |
| Affiliation |
Dabur India Limited |
| Address |
Dabur India Limited Plot No. 22, Site IV, Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
01203378405 |
| Fax |
01204552645 |
| Email |
sasibhushan.vedula@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 |
Plot Number 22, Site IV, Sahibabad, Ghaziabad, U.P.- 201010 |
| Type of Sponsor |
Other [Healthcare & FMCG] |
|
|
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 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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers with Normal Skin Type & Sensitive Skin Type |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| 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 and 7 days |
| Intervention |
1.Fem Naturals Hair Removable Cream- Rose
2.Fem Naturals Hair Removable Cream- Sandal
3.Fem Naturals Hair Removable Cream- Gold
4.Fem Naturals Herbal Bleach
5.Dabur Neem face wash
6.Dabur Red Soap
7.Dabur Baby Massage Oil (South)
8.Dabur Kesar Lal & Badam 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 and 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Group 1 Specific:
Subjects scoring less than or equal to 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumann’s skin type questionnaire.
Group 2 Specific:
Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumann’s skin type questionnaire.
Common to Group 1 & 2:
1.Healthy male and female subjects (1:1 ratio) in the age group of 18-65 years (both age inclusive).
2.Subjects representing with normal, oily, dry and combination skin type in equal ratio.
3.Subjects with normal 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. |
|
| ExclusionCriteria |
| Details |
Common to Group 1 & 2:
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 type and sensitive Skin Type |
Evaluation of Dermatological Safety of Investigational Products By 24 Hours Patch Test Under Complete Occlusion on Adult Healthy Human Subjects with Normal skin type and sensitive Skin Type |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
29/04/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 and day 7 after patch removal) |