CTRI

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CTRI Number

CTRI/2019/01/016971 [Registered on: 08/01/2019] Trial Registered Prospectively

Last Modified On:

07/01/2022

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Other (Specify) [Skin Sensitivity Test]

Study Design

Other

Public Title of Study

To study the safety of the test products by sensitivity test on healthy human subjects.

Scientific Title of Study

Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types.

Trial Acronym

None

Secondary IDs if Any

Secondary ID	Identifier
MSCR/ITPT/2018-05 Version 1.0 Dated 12 Dec 2018	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Sapna R
Designation	Principal Investigator
Affiliation	MS Clinical Research Pvt Ltd
Address	First floor, Sensitivity room,327/15, 1st Main Road Cambridge layout, Ulsoor Bangalore KARNATAKA 560008 India
Phone	08041125934
Fax	08040917253
Email	sapna.r@mscr.in

Details of Contact Person
Scientific Query

Name	Dr Sapna R
Designation	Principal Investigator
Affiliation	MS Clinical Research Pvt Ltd
Address	First floor, Sensitivity room,327/15, 1st Main Road Cambridge layout, Ulsoor KARNATAKA 560008 India
Phone	08041125934
Fax	08040917253
Email	sapna.r@mscr.in

Details of Contact Person
Public Query

Name	Dr Sapna R
Designation	Principal Investigator
Affiliation	MS Clinical Research Pvt Ltd
Address	First floor, Sensitivity room,327/15, 1st Main Road Cambridge layout, Ulsoor KARNATAKA 560008 India
Phone	08041125934
Fax	08040917253
Email	sapna.r@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, Bangalore- 560058, Karnataka, India.
Type of Sponsor	Other [FMCG(Fast moving Consumer Goods)]

Details of Secondary Sponsor

Name	Address
None	None

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Sapna	MS Clinical Research Pvt. Ltd.	First floor, Sensitivty room, 327/15, 1st Main Road Cambridge layout, Ulsoor Bangalore KARNATAKA	08041125934 08040917253 sapna.r@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

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Healthy male and Female Volunteers

Intervention / Comparator Agent

Type	Name	Details
Intervention	1.Face Mask 2.Face Mask 3.Face Mask 4.Face Mask 5.Skin Leave-On 6.Skin Leave-On 7.Soap 8.Soap 9.Soap 10.Soap 11.Soap 12. Soap 13.Soap 14. Soap 15.Rinse-Off 16.Rinse-Off 17.Rinse-Off 18.Colonge Spray 19. Colonge Spray 20.Perfume Spray	40 microliter of each investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter Frequency- once during the study period Route of administration- Topical Duration: 9 days for each subject
Comparator Agent	21.Negative control 22.Positive control 1 23.Positive control 2	40 microliter of Negative control (0.9N Saline), Positive control 1 (1% SLS)& Positive control 2 (3% SLS) will be applied on the back side of the subject along with the test products. Dose- 40 Microliter 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 - 55 years (both the ages inclusive). 2.Healthy male & female subjects. 3.Subjects with Fitzpatrick skin type III to V. 4.Subjects willing to give a voluntary written informed consent. 5.Subjects willing to maintain the patch test in position for 24 hours. 6.Subject having not participated in a similar investigation in the past two weeks. 7.Subjects willing to come for regular follow up visits. 8.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.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

Not Applicable

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	None

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

Phase 1

Date of First Enrollment (India)

10/01/2019

Date of Study Completion (India)

18/01/2019

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

Objective:

The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects.

Subject 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.

Duration of patch:

The patch will be kept for 24 hours.

References

Study method is based on the Bureau of Indian Standards (BIS) method 13424:2001 for the test product rinse off (soap): 119-185B.

Test method described in IS 13424:2001. Safety evaluation of bathing bars and toiletsoaps method of test (First revision, ICS 71.100.40), 2001.

Soap will be dissolved in distilled water to attain a final 8 % (w/W) dilution as per the clause 2.2.4 in IS 13424:2001.

Study method is based on the Bureau of Indian Standards (BIS) method 4011:2018- Third Revision - modified in terms of site of application.

Test method described in IS 4011:2018 Methods of test for safety evaluation of cosmetics, Third revision (ICS 71.100.40). Positive and negative control as per clause 4.3.1.2.4 and Irritation scoring system is as per the clause 4.3.1.3, 4.3.2.6 on Draize scale for scoring treatment sites.

Note- There was an error noted in the result section of IS 4011:2018, clause 4.3.1.4. in the BIS standard 4011:2018. The combined mean score of positive control is mentioned as less than 2.0 (which is supposed to be above 2.0) The same is been informed to the BIS Committee for the necessary corrections and has been acknowledged by them.