| CTRI Number |
CTRI/2019/07/020335 [Registered on: 23/07/2019] Trial Registered Prospectively |
| Last Modified On: |
27/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Safety & efficacy assessment of products on skin. |
|
Scientific Title of Study
|
To evaluate in-vivo safety and efficacy of the skin care formulation in terms of non-comedogenic effect on healthy human subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| XXX-2F01-ED-MY19 : Version No. 01 Dated 11/07/2019 |
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 |
Mascot-Spincontrol India Pvt. Ltd.
Unit 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
siddheshwar@mascotspincontrol.in |
|
Details of Contact Person
Scientific 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 (Suburban)
MAHARASHTRA
400013
India |
| Phone |
|
| Fax |
|
| Email |
mohit@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 (Suburban)
MAHARASHTRA
400013
India |
| Phone |
|
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Em Em Personal Care Pvt Ltd |
| Address |
314/317,Shah & Nahar Ind.Premises,Off Dr.E Moses Road,Worli,Mumbai 400018 |
| Type of Sponsor |
Other [FMCG] |
|
|
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. |
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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Oily & Mixed Oily skin type |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cleansing Oil |
Once daily application on face for 28 days |
| Comparator Agent |
N/AP |
N/AP |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| 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
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety & Efficacy assessment of products |
Screening, T0 days, T14 days, T28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety |
Screenig,T0, T14 days, T28 days |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/07/2019 |
| Date of Study Completion (India) |
27/08/2019 |
| 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. |