| CTRI Number |
CTRI/2022/03/040983 [Registered on: 10/03/2022] Trial Registered Retrospectively |
| Last Modified On: |
04/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [skin care formulations] |
| Study Design |
Other |
|
Public Title of Study
|
To assess the safety of test products on skin |
|
Scientific Title of Study
|
Evaluation of dermatological safety of investigational products by Single Application Closed patch test on healthy human volunteers of varied skin types |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 01/052/16 ; Version: 01; Dated: 17/06/2016 |
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 – 400013, INDIA
Mumbai
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 – 400013, INDIA
Mumbai
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
siddheshwar@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Ms Priya Shah |
| 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 – 400013, INDIA
Mumbai
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
priyashah8811@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| The study conducted at, Mascot Spincontrol India Pvt. Ltd.
Unit 2, Neeru Silk Mills, Mathuradas Mill compound, N.M. Joshi Marg - Lower Parel, Mumbai – 400013, INDIA |
|
|
Primary Sponsor
|
| Name |
ITC LSTC |
| Address |
ITC LSTC Peenya Industrial area, I Phase, Peenya Bangalore- 560058
Karnataka, India
|
| Type of Sponsor |
Other [Multinational] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| not applicable |
not applicable |
|
|
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
MAHARASHTRA |
022-43349191
siddheshwar@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Suraksa- Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Plaster 1[9740892] |
The plaster to be removed from the packaging and applied on the designated test site for 24 hours. after the 24 hours the plaster will be removed. |
| Intervention |
2. Plaster 2 [W547] |
The plaster to be removed from the packaging and applied on the designated test site for 24 hours. after the 24 hours the plaster will be removed. |
| Comparator Agent |
NIL |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Healthy & Clear Skin on back on the studied anatomic unit (free of psoriasis, eczema, , lichen plan, vitiligo, atopic dermatitis, acne, dysplastic nevi, or other skin pathologies ….)
Male and female volunteers in the age group of 18 to 50 years in generally good health Volunteer willing to participate in the study and provide signed informed consent for the same
Subjects representing varied skin types (ideally equal representation of all 4 skin types – Oily, Normal, Dry and combination)
|
|
| ExclusionCriteria |
| Details |
Volunteers hesitant to sign on Informed consent forms
Volunteers with known sensitivity to bandage or adhesive tape Volunteer who has participated in a similar clinical investigation in the last four weeks of study initiation Volunteer who is considered immunocompromised, or has a clinically-relevant history of or currently suffering from any disease or condition that, in the opinion of the investigator, might affect the evaluation of the study product or place the subject at undue risk
Volunteers with sunburns, uneven skin tone, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality on their back that would render the site non-conducive for visual assessment. Volunteers identified with clinically-relevant skin disease, including psoriasis, eczema, atopic dermatitis, acne, dysplastic nevi, or other skin pathologies, or a history of skin cancer, that may, in the opinion of the investigator, contraindicate participation or interfere with test site evaluations Volunteers on medication such as Antihistamines, Antifungals, Corticosteroids, Topical Steroids, etc. that might influence the study results
Female volunteers who are Pregnant or lactating
|
|
|
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 Single Application Closed patch test on healthy human volunteers of varied
skin types.
|
screening T0 T1day T2days T8days
|
|
|
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)
|
01/08/2016 |
| Date of Study Completion (India) |
10/08/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Objective: To evaluate the
dermatological safety of investigational product.
Duration of study: 10 days study
Kinetics:
T0 (Evaluation of test sites by Dermat and Subject,
Plaster application),
T2 (48 hrs) (Plaster
removal, Evaluation of test sites by Dermat and Subject post 30 minutes of
plaster removal), T3(Evaluation
of test sites by
Dermat and Subject post 24 hrs of plaster removal), T9 (Evaluation of test sites by
Dermat and Subject post 1 week of plaster 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
: Plaster
1[9740892], Plaster 2 [W547]
The test area is checked for
erythema and oedema caused due to the products. |