| CTRI Number |
CTRI/2019/08/020708 [Registered on: 14/08/2019] Trial Registered Prospectively |
| Last Modified On: |
27/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [N/AP] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety & efficacy assessment of products on skin |
|
Scientific Title of Study
|
To evaluate the in-vivo safety and efficacy of the skin care formulation in terms of non-comedogenic effect on healthy human subjects |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| XXX-2F01-AP-JE19; Version: 01; Dated: 25/07/2019 |
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 |
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 |
Unit 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel,
Mumbai, INDIA
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 |
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 |
Alembic Pharmaceuticals Ltd |
| Address |
3rd floor, Prime Corporate Park,
Behind ITC Grand Maratha Sheraton,
Sahar Road, Andheri (E), Mumbai – 400099 |
| Type of Sponsor |
Other [FMCG] |
|
|
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. |
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 |
Oily to mixed Skin Types |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Oryza cream(TR001) |
Twice application on face for 28 days on whole face |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Having oily or mixed oily skin on the face. |
|
| ExclusionCriteria |
| Details |
-For female: Do not take part in any family planning activities leading to pregnancy and breastfeeding
-Do not take part in another study liable to interfere with this study
-Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
-Do not change her/his cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety & Efficacy assessment of products |
Screening, T0 days, T14 days, T28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety |
Screening, T0 days, T14 days, T28 days |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2019 |
| Date of Study Completion (India) |
18/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The in-vivo safety and efficacy of the skin care formulation in terms of non-comedogenic effect on healthy human subjects. |