| CTRI Number |
CTRI/2022/03/041526 [Registered on: 31/03/2022] Trial Registered Prospectively |
| Last Modified On: |
02/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Skin Sensitivity test] |
| Study Design |
Other |
|
Public Title of Study
|
To check the safety of the products |
|
Scientific Title of Study
|
Evaluation of dermatological safety of investigational products by cumulative irritancy test for 14 days under complete occlusion |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SAFE/MACI/2022-02 Version 1.0 Dated 08 Mar 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vidya Kuntoji |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Ground floor, Sensitivity room no. 1, 327/15, 1st Main Road
Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
vidya@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritambhara |
| Designation |
Director- Business and Operation |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Room no.2, Ground floor,327/15, 1st Main Road Cambridge layout,
Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
ritambhara@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
Sudhanthiran S |
| Designation |
Study Manager |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
First Floor, Room no. 1, Councelling Area, 327/15, 1st main road, cambridge layout, ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
sudhan@mscr.in |
|
|
Source of Monetary or Material Support
|
| Marico Limited
Marks, plot no:23-C
Mahal, Industrial Estate
Mahakali Caves Road,
Andheri(E),
Mumbai 400093 |
|
|
Primary Sponsor
|
| Name |
Marico Limited |
| Address |
Marks, plot no:23-C Mahal, Industrial Estate Mahakali Caves Road, Andheri(E), Mumbai 400093 |
| Type of Sponsor |
Other [FMCG(Fast moving Consumer Goods)] |
|
|
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 Vidya Kuntoji |
MS Clinical Research Pvt. Ltd. |
Ground floor, Sensitivity
room No. 1 ,327/15, 1st
Main Road Cambridge
layout, Ulsoor
Bangalore
KARNATAKA |
08041125934
08040917253
vidya@mscr.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Clinicom Ethics Committee |
Approved |
| Clinicom Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Male and Female subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.RM.M480.67 |
40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical;
Duration: 15 days for each subject |
| Comparator Agent |
10.Positive control (1% SLS) |
40 µl of Positive control (1% SLS) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 15 days for each subject |
| Comparator Agent |
11.Positive control (3% SLS) |
40 µl of Positive control (3% SLS) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 15 days for each subject |
| Intervention |
2.RM.M480.74 |
40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 15 days for each subject |
| Intervention |
3.RM.M480.76 |
40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 15 days for each subject |
| Intervention |
4.RM.M480.70 |
40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 15 days for each subject |
| Intervention |
5.RM.M480.81 |
40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 15 days for each subject |
| Intervention |
6.RM.M480.77 |
40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 15 days for each subject |
| Intervention |
7.RM.M480.85 |
40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 15 days for each subject |
| Intervention |
8.RM.M480.86 |
40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 15 days for each subject |
| Comparator Agent |
9.Negative control (distilled Water) |
40 µl of distilled water will be applied back side of the subject. Dose- 40 Microliter;Route of administration- Topical; Duration: 15 days for each subject |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects in age group 18 - 65 years (both the ages inclusive).
2. Healthy male & female subjects with skin types normal, dry, oily, combination and sensitive skin type in equal ratio.
3. Subjects with Fitzpatrick skin type III to V.
4. Subjects in good health condition as per the medical screening criteria with
no disease state or physical condition that the Investigator believes could
interfere with the interpretation of the data.
5. Subject able to read, understand and sign an appropriate informed consent
form indicating her willingness to participate.
6. Subjects willing to give a voluntary written informed consent.
7. Subjects willing to maintain the patch test in position for 22-24 hours as
instructed.
8. Subjects willing not to apply any topical product at the test site for the entire study durations.
9. Subjects willing to refrain the test sites from direct sun light
10. Subject having not participated in a similar investigation in the past two
weeks.
11. Subjects willing to come for regular follow up visits.
12. Subjects ready to follow instructions during the study period. |
|
| ExclusionCriteria |
| Details |
1. Infection, allergy on the tested area.
2. Skin allergy, antecedents or atopic subjects.
3. Athletes and subjects with history of excessive sweating.
4. Cutaneous disease which may influence the study result.
5. Subjects on oral corticosteroid.
6. Subjects participating in any other cosmetic or therapeutic trial.
7. Subjects who are currently pregnant or lactating or planning to become pregnant in the period of study.
8. Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
9. More than one subject selected/participating from one family/household.
10. Subjects working with either MSCR or the sponsor. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the dermatological safety of the investigational products on healthy human subjects |
Approximately 14 days for each subject |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
NA |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/04/2022 |
| Date of Study Completion (India) |
19/04/2022 |
| 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
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study will be conducted to assess the safety of the test products. After consenting and qualifying the inclusion and exclusion criteria subjects will be enrolled into the study. For the selected subjects, the patch will be applied eveyday for 14 days. The assessment will be perfoemed for every 24 hrs once the patch is applied. |