| CTRI Number |
CTRI/2025/01/079227 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cosmetic study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
to check the effect of anti aging serum in both healthy Indian males and females in reducing wrinkles fine lines pigmentation |
|
Scientific Title of Study
|
A single centre open label study to evaluate effectiveness and safety of bioactive concentrate VC GROF in improving the signs of ageing in males and females with sensitive skin |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2324CICL002 Version 02 dated 10 Dec 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sneha Sonker |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
CIDP Biotech India Pvt Ltd
32-B First Floor Pusa Road Rajinder Nagar New Delhi India
Central
DELHI
110005
India |
| Phone |
9654331344 |
| Fax |
|
| Email |
s.sonker@cidp-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sneha Sonker |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
CIDP Biotech India Pvt Ltd
32-B First Floor Pusa Road Rajinder Nagar New Delhi India
DELHI
110005
India |
| Phone |
9654331344 |
| Fax |
|
| Email |
s.sonker@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sneha Sonker |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
CIDP Biotech India Pvt Ltd
32-B First Floor Pusa Road Rajinder Nagar New Delhi India
DELHI
110005
India |
| Phone |
9654331344 |
| Fax |
|
| Email |
s.sonker@cidp-cro.com |
|
|
Source of Monetary or Material Support
|
| Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai |
|
|
Primary Sponsor
|
| Name |
Cipla Ltd |
| Address |
Cipla Ltd
Cipla House Peninsula Business Park Ganpatrao Kadam Marg Lower Parel Mumbai 400013 |
| Type of Sponsor |
Research institution |
|
|
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 Sneha Sonker |
CIDP Biotech India Pvt Ltd |
CIDP Biotech India Pvt Ltd
32 B First Floor Pusa Road Rajinder Nagar New Delhi India
Central
DELHI |
9654331344
s.sonker@cidp-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with minimum grade 2 of fine lines and
wrinkles at crow’s feet, skin unevenness,
density of pigmentary spots, cheek sebaceous
pores as per Skin aging atlas |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Healthy male and female subjects with sensitive skin aged 35 years to 60 years old both inclusive
2 Fitzpatrick skin phototype III to VI
3 Subjects with minimum grade 2 of fine lines and wrinkles at crows feet skin unevenness density of pigmentary spots cheek sebaceous pores as per Skin aging atlas volume IV Indian skin type by BAZIN & FLAMENT
4 Subjects not using fairness skin spot lightening or antiaging or sunscreen creams lotions
5 Subjects not using any Vitamin C retinol niacinamide glutathione or any other serums creams or supplements which might interfere with study assessments
6 Subjects who have not undergone any aesthetic treatment chemical peels dermabrasion lasers botox fillers etc in the last 6 months and agree not to do in during the study period
7 Subject free of excessive hair acne cuts abrasions fissures wounds lacerations or any other active skin conditions on the face
8 Subject who agrees not to use any other product treatment on their face during the study period
9 Subject who agrees not to carry out bleaching or any other procedures including facial etc on face during the study period
10 Subject to agree to remove all Jewelry onaround face eg necklace earrings if possible nose ring during VISIA CR 5 imaging
11 Female subjects with child-bearing potential willing to undergo Urine Pregnancy Test and to use acceptable methods of contraception
12 Subjects who can read write and understand the informed consent document and are willing to give a written informed consent
13 Subjects ready to follow instructions and study restrictions during the study period |
|
| ExclusionCriteria |
| Details |
1 Subjects having known hypersensitivity to any of the study products or constituents
2 Subjects who are pregnant or lactating or who are planning to become pregnant during the study self-declared by subject on screening visit and test to be done on each evaluation visit
3 Participation in any other clinical trial up to 1 month prior to inclusion and during the study
4 Subjects who have any significant skin pathology in the test area
5 Subject who is currently taking any medication including food supplements which the Investigator believes may influence the interpretation of the data
6 Subject having chronic illness or had major surgery in the last year
7 Subjects undergoing any treatment of any skin condition on their face or body
8 Subjects having any allergy or sensitive to bar cleansing products creams or lotions artificial jewellry or anything else |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical scoring of fine lines and wrinkles on forehead crows feet wrinkles Skin smoothness skin suppleness skin evenness skin firmness density of pigmentary spots & contrast of isolated pigmentary spot skin radiance ptosis and cheek sebaceous pores using Skin aging atlas Volume 4 Asian Skin Type by Dermatologists Investigator
|
Visit 1 Screening visit Day minus 14
Visit 2 Baseline Day D0
Visit 3 Evaluation Visit Day 28
Visit 4 Evaluation Visit Day 56
Visit 5 End of the study visit Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Evaluation of skin crows feet wrinkles
forehead fine lines wrinkles & cheek sebaceous
pores using ANTERA 3D Device
2 Evaluation of skin & spot color using
Chromameter CR400
3 Evaluation of Skin hydration using
Corneometer CM 825®/MPA 6
4 Evaluation of TEWL using Tewameter TM
300TM Hex
5 Evaluation of skin firmness using Cutometer
MPA 580 |
Visit 1 Screening visit Day minus 14
Visit 2 Baseline Day D0
Visit 3 Evaluation Visit Day 28
Visit 4 Evaluation Visit Day 56
Visit 5 End of the study visit Day 84 |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/02/2025 |
| Date of Study Completion (India) |
07/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
07/05/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Population:Number of Subjects: 35 Demographics: Healthy males and females Age Range: 35 to 60 years
Completion Goal: Expected Completers: 30 subjects
Study Visits: 1 Visit 1 D-14 2 Visit 2 D0 3 Visit 3 D28 4 Visit 4 D56 5 Visit 5 D84 |