| CTRI Number |
CTRI/2018/02/011785 [Registered on: 08/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
07/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To check irritation potential of the given samples (Patch test) |
|
Scientific Title of Study
|
SINGLE APPLICATION CLOSED PATCH TEST TO EVALUATE THE SAFETY OF SKIN AND HAIR CARE FORMULATIONS ON HEALTHY HUMAN SUBJECTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SRC/CD/413, Version: 01, Dated: July 19, 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Vaishali Dhavan |
| Designation |
Scientist |
| Affiliation |
The KET’s, Scientific Research Centre |
| Address |
The KET’s, Scientific Research Centre,Cosmetology Division, 4th Floor,V. G. Vaze College Campus,Mulund(E),Mumbai
Mumbai (Suburban)
MAHARASHTRA
400081
India |
| Phone |
02225639644 |
| Fax |
02221635404 |
| Email |
vaishali@kelkarcosmetology.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Vaishali Dhavan |
| Designation |
Scientist |
| Affiliation |
The KET’s, Scientific Research Centre |
| Address |
The KET’s, Scientific Research Centre,Cosmetology Division, 4th Floor,V. G. Vaze College Campus,Mulund(E),Mumbai
Mumbai (Suburban)
MAHARASHTRA
400081
India |
| Phone |
02225639644 |
| Fax |
02221635404 |
| Email |
vaishali@kelkarcosmetology.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Vaishali Dhavan |
| Designation |
Scientist |
| Affiliation |
The KET’s, Scientific Research Centre |
| Address |
The KET’s, Scientific Research Centre,Cosmetology Division, 4th Floor,V. G. Vaze College Campus,Mulund(E),Mumbai
Mumbai (Suburban)
MAHARASHTRA
400081
India |
| Phone |
02225639644 |
| Fax |
02221635404 |
| Email |
vaishali@kelkarcosmetology.com |
|
|
Source of Monetary or Material Support
|
| ITC Ltd,Peenya Industrial Area, Peenya, Bangalore - 560058. Tel: 080 216303911 |
|
|
Primary Sponsor
|
| Name |
ITC Limited Peenya Industrial Area Peenya Bangalore |
| Address |
ITC Life Sciences and Technology CENTRE No. 3, 1st Main Road, Peenya Industrial Area, 1st phase.Bangalore - 560058. Tel: 080 216303911. |
| Type of Sponsor |
Research institution |
|
|
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 |
| Ms Vaishali Dhavan |
KETs Scientific Research Centre |
KETs Scientific Research Centre.V.G.Vaze College campus,Mithaghar Road, Mulund(E)Mumbai
Mumbai (Suburban)
MAHARASHTRA |
02225639644
02221635404
vaishali@kelkarcosmetology.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Scientific and Ethics Committee, Affiliated to KETs Scientific Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
skin patch test |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Deodorant Aerosol Spray (B. No. 84070) |
Day 1 (day of patch application), Day 2 (0 hrs. of Patch Removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal). |
| Intervention |
Deodorant Aerosol Spray (B. No. 84071) |
Day 1 (day of patch application), Day 2 (0 hrs. of Patch Removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal). |
| Intervention |
Deodorant Aerosol Spray (B. No. 84072) |
Day 1 (day of patch application), Day 2 (0 hrs. of Patch Removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal). |
| Intervention |
Deodorant Aerosol Spray (B. No. 84073) |
Day 1 (day of patch application), Day 2 (0 hrs. of Patch Removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal). |
| Intervention |
MADC-BR-1 |
Day 1 (day of patch application), Day 2 (0 hrs. of Patch Removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal). |
| Intervention |
Shampoo 18840 |
Day 1 (day of patch application), Day 2 (0 hrs. of Patch Removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal). |
| Comparator Agent |
Sodium Lauryl Sulphate 3% Solution |
Day 1 (day of patch application), Day 2 (0 hrs. of Patch Removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Volunteer (female/ male) in generally good health.
2.Volunteer between the ages of 18 and 50 years.
3.Volunteer has not participated in a similar clinical investigation in the past four weeks.
4.Volunteer willing to give a written informed consent and come for regular observation. |
|
| ExclusionCriteria |
| Details |
1.A known history or present condition of allergic response to any cosmetic products.
2.Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings.
3.Medications (e.g. steroids or antihistamines), which would compromise the study.
4.Pregnant or lactating females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| irritation potential |
first observation will be made at 30 minutes of patch removal (0 hr. observation). The further observations will be at 24 hrs and 1 week of patch removal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| investigational products to be tested for irritancy test |
On each subject’s back one patch of each investigational product will be applied on Day 1. This will be 9 days study. For all the products and positive control the subjects will be assessed by the study dermatologist on Day 1 (Day of patch application), Day 2 (0 hrs. of patch removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal). |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "23"
Final Enrollment numbers achieved (India)="23" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/08/2013 |
| Date of Study Completion (India) |
13/08/2013 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="9" |
|
Recruitment Status of Trial (Global)
|
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)?
|
|
Brief Summary
|
Skin Irritation Test: Irritants are substances that damage the skin. The damage will depend upon the nature, concentration and duration of exposure. Irritation is manifested as inflammatory responses such as erythema (redness), Oedema (swelling), and vesiculation and finally to an intense suppurate reaction without the involvement of the immune system. The irritation potential of a substance can be assessed by human patch test. |