| CTRI Number |
CTRI/2025/09/094093 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Reginald men Hermes Serum for skin Moisturisation |
|
Scientific Title of Study
|
A Single Arm Clinical study to Evaluate the efficacy of Reginald men Kratos
Moisturizer for skin Moisturisation. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT780 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 |
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 |
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 Hermes Serum |
Test Product: Reginald Men Kratos Moisturizer
Dose: Use Sufficient amount of moisturizer twice a day after face wash. 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 (80:20)
2. Subject having dull or dehydrated skin.
3. Age between18 to 45.
4. Subject willing to give written informed consent
5. Women of child bearing potential must have a negative urine pregnancy test
6. Free of any systemic and dermatologic disorder, which in the opinion of the investigator, will interface with the study results or increase the risk of AE.
7. Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or
artificial) for the duration of the study.
|
|
| ExclusionCriteria |
| Details |
1. Volunteers with skin conditions such as eczema, psoriasis, etc
2. Volunteers with oily skin .
3. Subjects who are pregnant , breast feeding or planning to become pregnant during the study .
4. Have any evidence of systematic cancer, squamous cell carcinoma, basal cell carcinoma in the last 5 years, or any other confounding skin condition.
5. Have open sore or open lesions in the treatment area
6. Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
7. Have participated in any interventional clinical trial in the previous 90 days.
8. Have a known sensitivity to any of the constituents of the test product including sensitivities to any of the constituents.
9. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medications (i.e., biologics), including corticosteroids.
10. Have a history of alcohol or illegal drug/ substance abuse or suspected alcohol or illegal drug/substance abuse in the past 2 years.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in skin hydration
2. Change in TEWL
3. Change in Smoothness and even skin tone
4. Change in Skin Gloss
5. HD Imaging- DSLR |
At day 0, T30min, Day 14 and Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
13/09/2025 |
| 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="1"
Days="0" |
|
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 single blind one arm study. Upon enrollment, each participant was assigned a regimen involving the investigational product and instructed to adhere to general safety and usage precautions as applicable.Participants were provided with a standardized moisturizer for use prior to product application. After cleansing and patting the face dry, sufficient amount of the investigational product were dispensed and applied as small dots across the face. The product was then gently spread using the fingertips in an outward direction, ensuring that it was not rubbed into the skin. The investigational product was applied twice daily — once in the morning and once at night — with a minimum interval of six hours between applications. This regimen was maintained for a total duration of 28 days. Male and female (80:20)
Assessment days: day 0, Day 14 and Day 28 Assessments: 1. Change in skin hydration 2. Change
in TEWL 3. Change in Smoothness and even
skin tone 4. Change in skin gloss |