| CTRI Number |
CTRI/2022/11/047456 [Registered on: 21/11/2022] Trial Registered Prospectively |
| Last Modified On: |
26/12/2022 |
| 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 24hrs patch test under complete occlusion on healthy human subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SAFE/PIPT/2022-02 Version 1.0 Dated 04 Nov 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Navya Annam |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Ground floor, Sensitivity dept, no. 1, 327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
8883338954 |
| Fax |
08040917253 |
| Email |
navya@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navya Annam |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Ground floor, Sensitivity dept, no. 1, 327/15, 1st Main Road Cambridge layout, Ulsoor
KARNATAKA
560008
India |
| Phone |
8883338954 |
| Fax |
08040917253 |
| Email |
navya@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navya Annam |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Ground floor, Sensitivity dept, no. 1, 327/15, 1st Main Road Cambridge layout, Ulsoor
KARNATAKA
560008
India |
| Phone |
8883338954 |
| Fax |
08040917253 |
| Email |
navya@mscr.in |
|
|
Source of Monetary or Material Support
|
| ITC Life Sciences & Technology Centre, Peenya Industrial Area, I Phase, Peenya,Bangalore- 560058, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences Technology Centre |
| Address |
Peenya Industrial Area, I Phase, Peenya |
| 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 Navya Annam |
MS Clinical Research Pvt. Ltd. |
Ground floor, Sensitivity room No. 1 ,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA |
08041125934
08040917253
navya@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Male and Female subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Soap (TSP 136-25) |
40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microlitre; Frequency- once during the study period; Route of administration- Topical; Duration: 9 days for each subject |
| Intervention |
10. Soap (TSP 128-120) |
40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microlitre; Frequency- once during the study period; Route of administration- Topical; Duration: 9 days for each subject |
| Comparator Agent |
11. Negative control (0.9N Saline) |
40 microlitre of Negative control (0.9N Saline) will be applied on the back side of the subject along with the test products. Dose- 40 Microlitre; Frequency- once during the study period; Route of administration- Topical; Duration: 9 days for each subject |
| Comparator Agent |
12.Positive control (3% SLS) |
40 microlitre of Positive control (3% SLS) will be applied on the back side of the subject along with the test products. Dose- 40 Microlitre; Frequency- once during the study period; Route of administration- Topical; Duration: 9 days for each subject |
| Intervention |
2. Soap (TSP 136-34) |
40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microlitre; Frequency- once during the study period; Route of administration- Topical; Duration: 9 days for each subject |
| Intervention |
3. Soap (TSP 137-28) |
40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microlitre; Frequency- once during the study period; Route of administration- Topical; Duration: 9 days for each subject |
| Intervention |
4. Soap (TSP 137-29) |
40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microlitre; Frequency- once during the study period; Route of administration- Topical; Duration: 9 days for each subject |
| Intervention |
5. Soap (TSP 137-25B) |
40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microlitre; Frequency- once during the study period; Route of administration- Topical; Duration: 9 days for each subject |
| Intervention |
6. Soap (TSP 137-25C) |
40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microlitre; Frequency- once during the study period; Route of administration- Topical; Duration: 9 days for each subject |
| Intervention |
7. Soap (TSP 137-26C) |
40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microlitre; Frequency- once during the study period; Route of administration- Topical; Duration: 9 days for each subject |
| Intervention |
8. Soap (TSP 137-27C) |
40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microlitre; Frequency- once during the study period; Route of administration- Topical; Duration: 9 days for each subject |
| Intervention |
9. Soap (TSP 128-119) |
40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microlitre; Frequency- once during the study period; Route of administration- Topical; Duration: 9 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 as defined in the population details under appendix
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 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 |
1. Subjects with infection, allergy on the tested area.
2. Subjects with skin allergy, antecedents or atopic subjects.
3. Athletes and subjects with history of excessive sweating.
4. Subjects with 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. Subjects with 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 MSCR |
|
|
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 9 days for each subject. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
NA |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/11/2022 |
| Date of Study Completion (India) |
15/12/2022 |
| 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 Objective: The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects. Study Population: 24 healthy human volunteers (Male and Female 1:1) with Skin types (Oily, Dry, Normal and Combination, 1:1:1:1 ratio). Duration of study: Approximately 9 days for each volunteer. Test Site: Between the scapula and waist of the subjects, the test site should be free of pigmentation, pimple, hair, mole or any dermatological condition that can interfere with the reading. Patch Application: The loaded patch system is applied at the test site of study subjects starting with the lower edge of the patch system and slowly pressing upwards till the top edge in order to squeeze out the air. Patch Methodology: The patch will be kept for 24 hours. The patch will be removed after 24 hours. The test sites will be wiped with a clean tissue to remove any residue prior to evaluation. Dermatologist will visually assess the skin condition of each test site at the following frequencies- 20-30 minutes’ post patch removal (0 hour reading), 24 hrs and 7 days’ post patch removal as per Draize scoring system. |