| CTRI Number |
CTRI/2025/10/096411 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| 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 the Baypure Clearing Serum |
|
Scientific Title of Study
|
A single-arm, open-label clinical study to evaluate the efficacy and safety of the Baypure Clearing Serum in improving skin pigmentation, dark spots, hydration, and overall skin Parameters |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT887 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: Clearing Serum |
Apply 5–6 drops applied topically on face and neck, twice daily.
Duration: 28 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female, 18–45 years old
2. Visible pigmentation or dark spots
3. Willing to provide written informed consent
4. Women of childbearing potential must have a negative urine pregnancy test
5. Able and willing to comply with study procedures |
|
| ExclusionCriteria |
| Details |
1. Pregnant or breastfeeding women
2. History of systemic or skin cancers within the last 5 years
3. Open sores or lesions in the treatment area
4. Participation in another interventional trial within the past 90 days
5. Known hypersensitivity to serum ingredients
6. Use of immunosuppressive or immunomodulatory medications
7. Any dermatological or systemic condition that may interfere with study results |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. change in Skin Pigmentation
2. change in Skin Color
3. change in Skin Hydration
4. change in TEWL
5. change in Dark Spots
6. change in Visioscan Imaging |
At t0, t30min, t14days, t28days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SGA |
At t28days |
|
|
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)
|
03/11/2025 |
| 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
|
This is an open-label, single-arm study. Participants will apply the Clearing Serum twice daily for 28 days.
Assessments will be performed at baseline (Day 0), Day 14, and Day 28.
Instrumental Assessments: [Comparing data of D14 and baseline, same Day 28 and baseline] • Skin Pigmentation: Mexameter – Melanin Index (Day 0, 14, 28) • Skin Color: Colorimeter (Day 0, 14, 28) [Also, could be marker for Tanning] • Skin Hydration: Corneometer (Day 0, 14, 28) • Skin Barrier Function: TEWAmeter (Day 0, 14, 28) • Dark Spots: Visioface (Day 0, 14, 28) • Visioscan Imaging: Day 0 and 28 • HD Photography: DSLR, Day 0 and 28
Dermatologist Evaluation (5-point ordinal scale): • Even Skin Tone (Day 0, 14, 28) • Acne Scars (Day 0, 14, 28) • Smoothness (Day 0, 14, 28) |