| CTRI Number |
CTRI/2018/05/013745 [Registered on: 07/05/2018] Trial Registered Prospectively |
| Last Modified On: |
08/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
To know the safety of Investigational products by assessing the irritation after patch application on
healthy human volunteers |
|
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 |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q28-ZC-AL18 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siddheshwar Mathpati |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
MASCOT-SPINCONTROL India Pvt. Ltd.
Unit 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel,
Mumbai, INDIA
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
siddheshwar@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddheshwar Mathpati |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
MASCOT-SPINCONTROL India Pvt. Ltd.
Unit 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel,
Mumbai, INDIA
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
siddheshwar@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
MASCOT-SPINCONTROL India Pvt. Ltd.
Unit 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel,
Mumbai, INDIA
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITC LIMITED ITC Life Sciences and Technology Centre |
| Address |
ITC Life Sciences and Technology Centre, No. 3, 1st Main Road, Peenya Industrial Area, I Phase Peenya, Bangalore- 560058, India |
| Type of Sponsor |
Other [(Multinational)] |
|
|
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 Siddheshwar Mathpati |
MASCOT-SPINCONTROL India Pvt. Ltd. |
MASCOT-SPINCONTROL India Pvt. Ltd.
Unit 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel,
Mumbai – 400013, INDIA
Mumbai (Suburban)
MAHARASHTRA |
022-43349191
siddheshwar@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethos- An Institutional Ethics committee (Mumbai) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Skin Leave -On (BMEO01)
2. Skin Leave -On (BMEO02)
3. Skin Leave -On (GFEO01)
4. Skin Leave -On
(GFEO02)
5. Skin Leave - On
(LGEO01)
6. Skin Leave - On
(LGEO02)
7. Skin Leave - On
(LGEO03)
8. Skin Leave - On
(LGEO04)
9. Skin Leave - On
(PMEO01)
10. Skin Leave - On
(PMEO02)
|
1. For products 1 to 10, the product is leave on product, so are placed directly in the aluminum chambers of the patch and applied on the back of the volunteers at T0 visit. |
| Comparator Agent |
Sodium Lauryl Sulphate (SLS) 3% Solution |
3% Solution |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Skin is healthy on the studied anatomic unit (free of eczema,wounds,inflammatory scar….)
Subjects representing varied skin types (ideally equal representationof all 4 skin types – Oily, Normal, Dry and combination)Subjects willing to come for regular follow up and ready to followinstructions during the study period |
|
| ExclusionCriteria |
| Details |
For female : Being pregnant or breastfeeding or having stopped tobreastfeed in the past three months, Having refused to give his/herassent by signing the consent form,Taking part in another studyliable to interfere with this study, Being diabetic,Being asthmatic,Having eczema, oriasis, lichen plan,vitiligo whatever the considered area, Having disorder of the healing
(whatever the considered area),Having a rhinitis, allergicconjunctivitis or rhinosinusitis |
|
|
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
investigational products by primary irritation
patch test on healthy human volunteers of varied
skin types
|
T0,T1,T2,T8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
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)
|
22/05/2018 |
| Date of Study Completion (India) |
25/05/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/05/2018 |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="8" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Single Application, occlusive, Closed Patch Test is conducted to measure the irritation potential of cosmetic products on the skin. Objective: To evaluate the dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types. Duration of study: 8 days study Kinetics: T0 (Evaluation of test sites by Dermat and Subject, Patch application), T+30mins post patch application, T1(Patch removal, Evaluation of test sites by Dermat and Subject post 30 minutes of patch removal), T2(Evaluation of test sites by Dermat and Subject post 24 hrs of patch removal), T8 (Evaluation of test sites by Dermat and Subject post 1 week of patch removal and tracking the positive cases) Population 24 healthy subjects(12 males + 12 females) The subjects are selected on the basis of skin types: 3 males + 3 females for dry skin 3 males + 3 females for oily skin 3 males + 3 females for combination skin 3 males + 3 females for normal skin Products: Skin Leave- On (BMEO01), Skin Leave – On (BMEO02), Skin Leave- On (GFEO01), Skin Leave - On (GFEO02), Skin Leave – On (LGEO01), Skin Leave – On (LGEO02), Skin Leave – On (LGEO03), Skin Leave – On (LGEO04), Skin Leave – On (PMEO01), Skin Leave – On (PMEO02), Positive control: 3% SLS The test area is checked for erythema and oedema caused due to the products and compared with positive control |