| CTRI Number |
CTRI/2022/07/044410 [Registered on: 27/07/2022] Trial Registered Prospectively |
| Last Modified On: |
09/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A dermatological study to evaluate the skin care formulations (intensive eye cream) for skin like reduce dry & dehydrated lines, clears, brightens, smoothens and nourishes the eye area, brightens dark circles, improve under eye puffiness on healthy participants. |
|
Scientific Title of Study
|
A single centre, prospective dermatological study to evaluate the parameters on skin like reduce dry & dehydrated lines, clears, brightens, smoothens and nourishes the eye area, brightens dark circles, improve under eye puffiness with skin care formulations (intensive eye cream) in healthy volunteers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MVS/CPS/11/2022; Version No.: 1.0; Dated: 13 May 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Esha Roy |
| Designation |
Principal Investigator (Dermatologist) |
| Affiliation |
Qaaf Healthcare International |
| Address |
Clinical Division, A-62,Basement Room No. B01,
DDA Shed Okhla Industrial Area, Phase II
South
DELHI
110020
India |
| Phone |
9254425442 |
| Fax |
|
| Email |
dresharoy5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Nishant Singh |
| Designation |
Deputy Manager Regulatory Affairs |
| Affiliation |
Mountain Valley Springs India Pvt. Ltd. |
| Address |
B12, Block B
Sector 3, Noida
South
DELHI
201301
India |
| Phone |
08860800289 |
| Fax |
|
| Email |
nishant.singh@forestessentialsindia.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Nishant Singh |
| Designation |
Deputy Manager Regulatory Affairs |
| Affiliation |
Mountain Valley Springs India Pvt. Ltd. |
| Address |
B12, Block B
Sector 3, Noida
DELHI
201301
India |
| Phone |
08860800289 |
| Fax |
|
| Email |
nishant.singh@forestessentialsindia.com |
|
|
Source of Monetary or Material Support
|
| Mountain Valley Springs India Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Mountain Valley Springs India Pvt Ltd |
| Address |
B12 Block B Sector 3 Noida Uttar Pradesh India |
| Type of Sponsor |
Other [Cosmetic Company] |
|
|
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 Esha Roy |
Qaaf Healthcare International |
Clinical division, A-62,Basement Room No. B01, DDA Shed, Okhla Industrial Area, Phase II
South
DELHI |
9254425442
dresharoy5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Society for research welfare Independent ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
The objective of study is to evaluate the Dermatological efficacy with skin care formulations (intensive eye cream) on healthy participants |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: intensive eye cream , Reference: NA, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 0.5(g), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 40 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Healthy subjects (no infectious and evaluative pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory check-up)
Indian Male/Female subjects.
Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar etc)
Between 20 to 65 years of age, with normal skin condition.
Written informed consent signed by the subject in line with applicable regulation of country.
|
|
| ExclusionCriteria |
| Details |
Having refused to give her consent by not signing the consent form.
Taking part in another study liable to interfere with this study.
Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis).
Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
Having cutaneous hypersensitivity.
Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation will include assessment of local adverse events of redness, itching, rashes and burning sensations and any other local side effect and will be categorized non serious (based on severity grades, patterns, and causality) and serious adverse events. There will be two types of assessment, subject self-assessment and dermatological evaluation by study investigator |
Assessment will be done at 30 min, 20 days and 40 days of application. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a single center, prospective study to evaluate efficacy
and safety of skin care formulations (INTENSIVE EYE CREAM) in healthy
volunteers. This study will be conducted in compliance with applicable national
regulations for post marketing requirement of cosmetic products with the aim of
identifying or quantifying safety hazards relating to an authorized cosmetic
product and is aligned with various guidelines and recommendations for good
pharmacovigilance practices for cosmetic products |