| CTRI Number |
CTRI/2022/03/041259 [Registered on: 22/03/2022] Trial Registered Prospectively |
| Last Modified On: |
01/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda
Other (Specify) [COSMETIC PRODUCT CATEGORY] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A SINGLE CENTRE PROSPECTIVE STUDY TO EVALUATE THE EFFICACY (HYDRATE ,TONES, BRIGHTNESS AND RADIANCE) OF SOUNDARYA RADIANCE CREAM |
|
Scientific Title of Study
|
A SINGLE CENTRE, PROSPECTIVE STUDY TO EVALUATE DERMATOLOGICAL STUDY DISCERNIBLE FOR SPECIFIC PARAMETERS THAT HYDRATE, TONES AND BRING BRIGHTNESS & RADIANCE IN SKIN CARE FORMULATIONS (SOUNDARYA RADIANCE CREAM) IN HEALTHY VOLUNTEERS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MVS/CPS/01/2022,Version: 1.0 Dated: 10 January 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 |
A-62, Basement Room No. B01, DDA Shed,
Okhla Industrial Area,
Phase II
New Delhi
DELHI
110020
India |
| Phone |
9254425442 |
| Fax |
|
| Email |
esharoy86@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 |
Mountain Valley Springs India Pvt. Ltd.
B12 Block B Sector 3 Noida
Gautam Buddha Nagar
UTTAR PRADESH
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 |
Mountain Valley Springs India Pvt. Ltd.
B12 Block B Sector 3 Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
08860800289 |
| Fax |
|
| Email |
nishant.singh@forestessentialsindia.com |
|
|
Source of Monetary or Material Support
|
| Mountain Valley Springs India Pvt. Ltd. India |
|
|
Primary Sponsor
|
| Name |
Mountain Valley Springs India Pvt Ltd |
| Address |
Mountain Valley Springs India Pvt. Ltd. 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 HEATHCARE INTERNATIONAL |
A62 DDA SHED OKHLA PHASE II OKHLA INDUSTRIAL AREA NEW DELHI 110020
South
DELHI |
9254425442
esharoy86@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 the study is to evaluate the dermatological efficacy of Soundarya Radiance Cream in healthy volunteers |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: GOLD BHASMA, Reference: NA, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 5(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 40 Days, Reference: NA, Route: NA, Dosage Form: Kalka/ Paste, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) 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)
2) Indian Male/Female subjects.
3) Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar etc)
4) Between 20 to 65 years of age, with normal skin condition.
5) Written informed consent signed by the subject in line with applicable regulation of country. |
|
| ExclusionCriteria |
| Details |
1) Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis).
2) Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
3) Having cutaneous hypersensitivity.
4) 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).
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The criteria for the assessment of will be described in terms to evaluate specific parameters that hydrate, tones and bring brightness & radiance in skin care formulations (Soundarya Radiance cream) in healthy volunteer Evaluation will be based on:
Subject’s self-assessment
Dermatological evaluation by medically qualified study investigator |
Subject Assessment will be done at 30 minutes, 20 days and 40 days after test product application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety evaluation by the investigator will be done at the end of the study. |
40 days |
|
|
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)
|
22/03/2022 |
| 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="2"
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 centre, prospective, open label, non-comparative study to evaluate the efficacy of skin care formulation, SOUNDARYA RADIANCE CREAM in healthy volunteers. This study will be conducted in compliance with applicable national regulations for Post Marketing Surveillance of cosmetic product with the aim of identifying or quantifying safety hazards relating to an authorized cosmetic product and is aligned with various guidelines and recommendations for guideline on PMS practices for cosmetic products. |