| CTRI Number |
CTRI/2025/11/097111 [Registered on: 10/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [skin sensitivity test] |
| Study Design |
Other |
|
Public Title of Study
|
safety testing of test products using 24 hours patch test. |
|
Scientific Title of Study
|
Evaluation of dermatological safety of investigational products by 24hrs patch test under semi, open and complete occlusion on healthy Indian human participants of varied skin types. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SAFE/ITPT/2025-03, version 1.0, dated 08 Oct 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandan B C |
| Designation |
principal investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
MS Clinical Research Pvt. Ltd, #324,1st Main Road, Cambridge layout Ulsoor
MS Clinical Research Pvt. Ltd 327/15 1st Main Road Cambridge
layout Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
09952700028 |
| Fax |
|
| Email |
chandan@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RITAMBHARA |
| Designation |
Director- Business and operations |
| Affiliation |
M S CLINICAL RESEARCH PVT.LTD |
| Address |
327/15, GROUND FLOOR, CAMBRIDGE LAYOUT, ULSOOR,
MS Clinical Research Pvt. Ltd 327/15 1st Main Road Cambridge
layout Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
09952700028 |
| Fax |
|
| Email |
ritambhara@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Radha S |
| Designation |
Manager skin science |
| Affiliation |
MS Clinical Research Pvt. Ltd. |
| Address |
MS Clinical Research Pvt. Ltd 327/15 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
09952700028 |
| Fax |
|
| Email |
radha@msclinical.com |
|
|
Source of Monetary or Material Support
|
| ITC Life Sciences and Technology Centre, Peenya Industrial Area, I Phase, Peenya, Bangalore- 560058, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences and Technology Centre |
| Address |
Peenya Industrial Area, I Phase, Peenya, Bangalore- 560058, Karnataka, India. |
| Type of Sponsor |
Other [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 Chandhan B C |
MS Clinical Research Pvt. Ltd |
MS Clinical Research Pvt. Ltd, Department of Sensitivity, Ground floor, Room number 1, 327/15 1st Main Road Cambridge
layout, Ulsoor
Bangalore
KARNATAKA |
09952700028
chandhan@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwara Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy male and female participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
18-076 A |
Product will be in contact with skin for 24h under occlusion/semi-occlusion as per BIS 4011:2018 guidelines |
| Intervention |
19-053 A |
Product will be in contact with skin for 24h under occlusion/semi-occlusion as per BIS 4011:2018 guidelines
|
| Intervention |
19-053 B |
Product will be in contact with skin for 24h under occlusion/semi-occlusion as per BIS 4011:2018 guidelines
|
| Intervention |
19-054 A |
Product will be in contact with skin for 24h under occlusion/semi-occlusion as per BIS 4011:2018 guidelines |
| Intervention |
19-054 B |
Product will be in contact with skin for 24h under occlusion/semi-occlusion as per BIS 4011:2018 guidelines |
| Comparator Agent |
Negative control-Isotonic Saline - 0.9% |
Product will be in contact with skin for 24h under occlusion/semi-occlusion as per BIS 4011:2018 guidelines |
| Intervention |
OTC-015-042C |
Product will be in contact with skin for 24h under occlusion/semi-occlusion as per BIS 4011:2018 guidelines |
| Intervention |
OTC-016-062A |
Product will be in contact with skin for 24h under occlusion/semi-occlusion as per BIS 4011:2018 guidelines |
| Intervention |
OTC-016-062B |
Product will be in contact with skin for 24h under occlusion/semi-occlusion as per BIS 4011:2018 guidelines |
| Intervention |
OTC-016-062C |
Product will be in contact with skin for 24h under occlusion/semi-occlusion as per BIS 4011:2018 guidelines |
| Intervention |
OTC-016-062F |
Product will be in contact with skin for 24h under occlusion/semi-occlusion as per BIS 4011:2018 guidelines |
| Intervention |
OTC-016-062H |
Product will be in contact with skin for 24h under open patch as per BIS 4011:2018 guidelines |
| Comparator Agent |
Positive control - SLS – 1% (PC-1) w/w in distilled water |
Product will be in contact with skin for 24h under occlusion/semi-occlusion as per BIS 4011:2018 guidelines |
| Comparator Agent |
Positive control - SLS –3% (PC-2) w/w in distilled water |
Product will be in contact with skin for 24h under occlusion/semi-occlusion as per BIS 4011:2018 guidelines |
| Intervention |
TSP 143 053 |
Product will be in contact with skin for 24h under occlusion/semi-occlusion as per BIS 4011:2018 guidelines |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants in age group 18 - 65 years (both the ages inclusive).
2. Healthy male & female participants with skin types as defined in the population details under appendix.
3. Participants with Fitzpatrick skin type III to V
4. Participants 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. Participant able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
6. Participants willing to give a voluntary written informed consent.
7. Participants willing to maintain the patch test in position for 24 hours.
8. Participant having not participated in a similar investigation in the past two weeks.
9. Participants willing to come for regular follow up visits.
10. Participants ready to follow instructions during the study period. |
|
| ExclusionCriteria |
| Details |
1. Participants with infection, allergy on the tested area.
2. Participants with skin allergy, antecedents or atopic participants.
3. Athletes and participants with history of excessive sweating.
4. Participants with cutaneous disease which may influence the study result.
5. Participants on oral corticosteroid.
6. Participants participating in any other cosmetic or therapeutic trial.
7. Participants who are currently pregnant or lactating or planning to become pregnant in the period of study.
8. Participants 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 Participant selected/ participating from one family/ household.
10. Participants working with MSCR |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The objective of the study is to determine the potential irritation of the test formulation in varied skin types in a Primary Irritation Patch Test. |
Baseline, 0-hour, 24-hour and Day7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/11/2025 |
| Date of Study Completion (India) |
21/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is conducted in accordance with Bureau of Indian Standards (BIS) 13424:2001 and 4011:2018 for the Safety Evaluation of Cosmetic Samples in human participants. The objective is to evaluate the skin irritation potential of a cosmetic test sample following a single 24-hour occlusive patch application on the upper back of healthy adult volunteers. Participants will be screened to ensure the absence of any dermatological or physical conditions that may interfere with test results. Written informed consent will be obtained from all participants prior to enrollment.
The test sample will be applied on a defined skin site between the scapula and waist (upper back) under an occlusive patch for 24 hours. After patch removal, skin reactions such as erythema, oedema, or papules will be evaluated subjectively using the Draize Scale. A follow-up assessment will be performed one week later to confirm recovery. The total study duration per participant will be approximately 9 days. |