| CTRI Number |
CTRI/2017/08/009271 [Registered on: 04/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
27/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of the skin safety of 1 soap, for skin irritation using a patch test. |
|
Scientific Title of Study
|
Evaluation of the skin safety of 1 soap, for primary skin irritation using a patch test. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/026/0617/STU |
Protocol Number |
| Version No.: 1 of 30th June 2017 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
C.L.A.I.M.S. PVT.LTD |
| Address |
C.L.A.I.M.S. PVT.LTD ,
4th floor, B wing,
Modi House, C-10, Dalia Industrial Estate,
New Link Road, Andheri (W), Mumbai
Mumbai
MAHARASHTRA
400058
India |
| Phone |
66758851 |
| Fax |
|
| Email |
rsjdr@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
C.L.A.I.M.S. PVT.LTD |
| Address |
C.L.A.I.M.S. PVT.LTD ,
4th floor, B wing,
Modi House, C-10, Dalia Industrial Estate,
New Link Road, Andheri (W), Mumbai
MAHARASHTRA
400058
India |
| Phone |
66758851 |
| Fax |
|
| Email |
rsjdr@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vadiraj Ekkundi |
| Designation |
Vice President, R&D |
| Affiliation |
VVF (India) Limited |
| Address |
VVF (India) Limited,
Div: Softsens Consumer Product Pvt. Ltd.
109, Opp.Sion Fort Garden,
Sion (E), Mumbai
Mumbai
MAHARASHTRA
400 022
India |
| Phone |
02240282403 |
| Fax |
|
| Email |
Vadiraj.ekkundi@vvfltd.com |
|
|
Source of Monetary or Material Support
|
| VVF (India) Limited,
109, Opp. Sion Fort Garden,
Sion (E), Mumbai 400 022, INDIA.
|
|
|
Primary Sponsor
|
| Name |
VVF India Limited |
| Address |
VVF (India) Limited
Div: Softsens Consumer Product Pvt. Ltd.
109, Opp.Sion Fort Garden,
Sion (E), Mumbai 400 022
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajiv Joshi |
C.L.A.I.M.S. Pvt. Ltd. |
4th floor, B wing,
Modi House, C-10, Dalia Industrial Estate,
New Link Road, Andheri (W), Mumbai-400058
Mumbai
MAHARASHTRA |
66758851
66758853
rsjdr@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with healthy skin on test area |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3% w/w solution of sodium lauryl sulphate |
3% w/w (dose) solution of sodium lauryl sulphate will be filled in well of Patch chambers which will be applied occlusively on upper arm of participants once |
| Intervention |
Abzorb Syndet Bar Soap (1% Clotrimazole) |
At VISIT 1 (0 hrs): 8% w/w solution of the soap will be prepared. 40 microlitre (dose) of the test product (filter papers dipped in liquid product) will be filled in well of Patch chambers which will be applied occlusively on upper arm of participants once. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Voluntary men and/or women between 18 and 65 years.
• Having apparently healthy skin on test area.
• Willingness to discontinue the use of cleansing and/or cosmetic products in the treatment areas during the course of the study.
• Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
• Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna…), during the course of the study.
• Ready to wear loose cotton clothes.
|
|
| ExclusionCriteria |
| Details |
• Pregnant women and lactating women (by history).
• Scars, excessive terminal hair or tattoo on the studied area.
• Dermatological infection/pathology on the level of studied area.
• Hypersensitivity, allergy antecedent (to any cosmetic product, raw material).
• Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
• Participants 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).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patch Scoring (Erythema and oedema scoring)at 48 hours and 72 hours |
Patch Scoring (Erythema and oedema scoring)at 48 hours and 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2017 |
| Date of Study Completion (India) |
02/08/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
There will be 2 products involved in the study - 1 test product and 3% w/w Sodium Lauryl sulphate solution. For this study, we need people who show a reaction to Sodium Lauryl Sulphate (Positive Control). Hence an additional patch containing 0.04 ml of 3% w/w SLS solution will be applied on participants to determine people showing a reaction to 3% SLS. At VISIT 1 (0 hrs): 8% w/w solution of the soap will be prepared. 40 ml of the test products (filter papers dipped in liquid product) and 3% w/w solution of sodium lauryl sulphate will be filled in different wells of Patch chambers which will be applied occlusively on upper arm of participants by Clinical Research Associates at Hour 0. Duration of occlusion will be 24 hours. At VISIT 2 (24 hrs): Patch will be removed. At VISIT 3 (48 hrs): Scoring of test area (skin on upper arm) will be performed. Participants will be called for follow up visit at 72 hours. If reactions are observed they will be called 1 week thereafter and later if necessary at the discretion of the Investigator. |