| CTRI Number |
CTRI/2019/11/022065 [Registered on: 19/11/2019] Trial Registered Prospectively |
| Last Modified On: |
10/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Other |
|
Public Title of Study
|
To check irritation potential of the given samples (Patch test) |
|
Scientific Title of Study
|
To Evaluate The Dermatological Safety Of The Investigational Products By Primary Irritation Patch Test On Healthy Human Volunteers With Sensitive Skin Type. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Meghana Surve |
| Designation |
Principal Investigator |
| Affiliation |
The KET’s, Scientific Research Centre |
| Address |
Cosmetology Division, 4th Floor,V. G. Vaze College Campus,Mulund(E),Mumbai
Mumbai (Suburban)
MAHARASHTRA
400081
India |
| Phone |
02225639644 |
| Fax |
|
| Email |
meghana@kelkarcosmetology.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Meghana Surve |
| Designation |
Principal Investigator |
| Affiliation |
The KET’s, Scientific Research Centre |
| Address |
Cosmetology Division, 4th Floor,V. G. Vaze College Campus,Mulund(E),Mumbai
Mumbai (Suburban)
MAHARASHTRA
400081
India |
| Phone |
02225639644 |
| Fax |
|
| Email |
meghana@kelkarcosmetology.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Meghana Surve |
| Designation |
Principal Investigator |
| Affiliation |
The KET’s, Scientific Research Centre |
| Address |
Cosmetology Division, 4th Floor,V. G. Vaze College Campus,Mulund(E),Mumbai
Mumbai (Suburban)
MAHARASHTRA
400081
India |
| Phone |
02225639644 |
| Fax |
|
| Email |
meghana@kelkarcosmetology.com |
|
|
Source of Monetary or Material Support
|
| ITC LIMITED
ITC Life Sciences and Technology CENTRE
No. 3, 1st Main Road,
Peenya Industrial Area, 1st phase
Bangalore - 560058
Tel: 080 216303911.
|
|
|
Primary Sponsor
|
| Name |
ITC LIMITED ITC Life Sciences and Technology CENTRE |
| Address |
ITC LIMITED
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 Meghana Surve |
The KETs Scientific Research Centre |
The KETs Scientific Research Centre, Cosmetology Division, 4th floor, V.G.Vaze College campus,Mithaghar Road, Mulund(E)Mumbai Mumbai (Suburban) MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA |
02225639644
meghana@kelkarcosmetology.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Scientific and Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
skin patch test |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Leave-on - 112-28 |
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 |
Leave-on - 116-61 |
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 |
Leave-on - DFMWMC-B001 1G D |
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 |
Leave-on- ITC-RO-001T5a |
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 |
Negative Control (0.9% Isotonic Saline 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). |
| Comparator Agent |
Positive Control (1% SLS) |
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 |
Rinse off - 114-56 |
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 |
Rinse off - 114-59 |
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 |
Rinse off - 114-66A |
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 |
Rinse off - 114-66B |
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 |
Rinse off - DFAACM-B001 GA |
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 |
Rinse off - DFADFC B001AD |
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 |
Rinse off - DFAQCM-7966 |
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 |
Rinse off - DFVFFC B00141A |
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 |
Rinse off - FBW450-GA |
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 |
Rinse off - FBW450-O |
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 |
Rinse off - SO 122-22 |
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 |
Rinse off - SO 122-23 |
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). |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Volunteer (female/ male) in generally good health.
2. Volunteer between the ages of 18 and 65 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.
5. Subjects scoring greater than 30 for Section 2- Sensitive Vs Resistant skin in modified Dr. Baumann’s sensitive skin Questionnaire.
6. Subject identified to have sensitive skin on basis of Dermatologist’s assessment of skin with fine texture and closeness of blood vessels to the surface.
|
|
| 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. Subjects under chronic medication (e.g. Antihistamines, Antifungals, Corticosteroids, topical Steroids, etc.) that might influence the outcome of the study.
4. Pregnant or lactating females.
5. Subjects participating in any other cosmetic or therapeutic trial.
|
|
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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="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/11/2019 |
| Date of Study Completion (India) |
05/12/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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. |