| CTRI Number |
CTRI/2025/10/096426 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy and Safety of Baypure Vitamin C & Ferulic Acid Serum |
|
Scientific Title of Study
|
A Single-Arm, Open-Label Clinical Study to Assess the Efficacy and Safety of Baypure Vitamin C & Ferulic Acid Serum in Enhancing Skin Brightness and Improving Overall Skin Health Parameters |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT886 Version 1.0 dated 06 Oct 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Robin Chugh |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
09027285265 |
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
08937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
UTTAR PRADESH
250005
India |
| Phone |
08937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| Baypure Lifestyle Pvt Ltd, 2nd Floor, 581, 1st Main Rd, Sector 6, HSR Layout, Bengaluru, Karnataka 560102, India. |
| CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial
Estate, Panchli, Baghpat Road, UTTAR PRADESH, 250005-India |
|
|
Primary Sponsor
|
| Name |
Baypure Lifestyle Pvt Ltd |
| Address |
2nd Floor, 581, 1st Main Rd, Sector 6, HSR Layout, Bengaluru, Karnataka 560102, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Robin Chugh |
CCFT laboratories |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH |
09027285265
robinderm25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMHRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product: Vitamin C & Ferulic Acid Serum |
Apply 5–6 drops applied topically on face and neck, twice daily.
Duration: 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Males and females aged 18–45 years.
2. Subjects with dull and mildly pigmented skin.
3. Willingness to provide written informed consent.
4. Female participants of childbearing potential: negative urine pregnancy test at screening.
5. Willing to avoid excessive sun exposure during study duration.
6. Free from systemic or dermatological disorders that may interfere with results. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating women or those planning pregnancy during the study.
2. History of skin cancers within the past 5 years.
3. Presence of active skin disease or open lesions or infections in the treatment area.
4. Known allergy to Vitamin C, Ferulic Acid, or excipients in the test product.
5. Use of systemic corticosteroids or immunosuppressive or biologic therapies within 90 days.
6. Participation in another interventional study within the past 90 days. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. change in Skin Gloss or brightness
2. change in Skin Lightness
3. change in Pigmentation
4. change in Hydration
5. change in TEWL
6. Dark Spots by visioscan
7. Texture & Smoothness
8. DSLR Imaging |
At t0, t30min, t14days, t28days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SGA |
At t28 days |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
05/11/2025 |
| 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="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
To evaluate the efficacy of Vitamin C & Ferulic Acid Serum in improving skin brightness and radiance
after 28 days of application.
Males and females aged 18–45 years.
Type: Prospective, single-arm, open-label study. Duration: 28 days. Visits: Baseline (Day 0), Interim (Day 14), End of Treatment (Day 28). Application: 5–6 drops applied topically on face and neck, twice daily, for 4 weeks. |