| CTRI Number |
CTRI/2025/09/094699 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| 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 Tolerance of Reginald Men Zeus Lip Serum/Balm |
|
Scientific Title of Study
|
A Clinical study to Evaluate the Efficacy and Tolerance of Reginald Men Zeus Lip Serum/Balm on Human Lips |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT778 Version 1.0 dated 06 Aug 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
|
| Btm Ventures Private Limited, Hd-062, Sy-11, Krishe Emerald Serlingampally Mandal, Kondapur, Rangareddi, Hyderabad- 500081 |
| CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road, Meerut, UTTAR PRADESH-250005 |
|
|
Primary Sponsor
|
| Name |
Btm Ventures Private Limited |
| Address |
Btm Ventures Private Limited, Hd-062, Sy-11, Krishe Emerald Serlingampally Mandal, Kondapur, Rangareddi, Hyderabad- 500081 |
| 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 |
2nd floor, 2nd room, 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: Reginald Men Zeus Lip Serum/Balm |
Test Product: Reginald Men Zeus Lip Serum/Balm
Dose: Gently use the Reginald men Zeus Lip Serum/Balm twice a day for 4 weeks.
Route of Administration: Topical, Duration: 28days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Gender: Male and Female with age 18-45 (80:20)
2)Presence of visible lip dryness, dullness or pigmentation.
3)Subjects willing to give written informed consent
4)Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
5. Signed informed consent form
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or nursing mothers
2. Current dermatological treatments on the lips.
3. Active cold sores, infections, open wounds, or trauma to the lips.
4.Tolerance rating included in the past-treatment questionnaire.
5.volunteers to report and discomfort or adverse events during the study period
6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures
7.Subjects on any medical treatment either systemic or topical which
may interfere with the performance of the study treatment (presently or in the past 1 month)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in hydration
2. Change in Melanin
3. DSLR imaging
4. Visual Grading
5. Dermascope imaging |
At t0, t30min, t28days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SGA |
t28days |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
23/09/2025 |
| 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
|
A clinical study to check the efficacy and tolerance ability
Test Product: Reginald Men Zeus Lip Serum/Balm
Dose: Gently use the Reginald men Zeus Lip Serum/Balm twice a day for 4 weeks.
Route of Administration: Topical
Duration: 28days
Assessments:
1. Change in hydration 2. Change in Melanin 3. DSLR imaging
4. Visual Grading
5. Dermascope imaging
Male and Female with age 18-45 (80:20) |