| CTRI Number |
CTRI/2026/01/100030 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Moisturizing activity of Hydration Serum |
|
Scientific Title of Study
|
A single blind clinical study to evaluate the Moisturizing potential of Hydration Serum |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT1025 Version 1.0 dated 26 Nov 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
|
| Anju LLC, Sharjah Media City(Shams) P o Box, UAE - 515000 |
| CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road, UTTAR PRADESH, 250005-India |
|
|
Primary Sponsor
|
| Name |
Anju LLC |
| Address |
Sharjah Media City(Shams) P o Box, UAE - 515000 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Panchali
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: Hydration serum |
Test Product: Hydration Serum
Dose: : Apply 0.5gm all over the face
Route of Administration: Topical
Duration: 28 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Gender: Female aged Between 40 to 55.
2. Non-pregnant, non-lactating female
3. No acne skin or acne prone skin.
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. The client has specified no subject should have melasma
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. Subjects who are pregnant, breast feeding, or planning to become pregnant during the study
2. Subjects having Moderate to severe pigmentation, sunburn, scar or any type of skin concern.
3. Volunteers with skin conditions such as eczema, psoriasis, etc
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 30 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 |
change in skin hydration
change in TEWL
change in skin firmness |
At T0min, 30min, 4hr, 8hr, 24hr, 14 day and 28day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
10/01/2026 |
| 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 single blind one arm study. Each participant entering the trial will be assigned to a regimen of
investigational product. Day 1- 0, 30min, 4hr, 8hr, 24hr, 14day and 28day . Skin Hydration (Corneometer): (0, 30min, 4hr, 8hr, 24hr, 14 day
and 28day) TEWL (Tewameter): (0, 30min, 24hr, 14 day and 28day) Skin Firmness/Elasticity (Cutometer Assessment): (0, 30min,
24hr, 7day, 14 day and 28day) 1. R0= Firmness (Initial Deformation), 2. R7= Biological Elasticity Dermat evaluation on a 5 point ordinal scale would be used for
the Wrinkle Depth (0, 14 day and 28day) Dermat evaluation on a 5 point ordinal scale would be used for
the Volume (0, 14 day and 28day) Dermat evaluation on a 5 point ordinal scale would be used for
the Roughness (0, 14 day and 28day) Dermat evaluation on a 5 point ordinal scale would be used for
the Roughness (0, 14 day and 28day)
HD Imaging with DSLR: ((0, and 28day))
30 mint Post-Application (After First Application of Product):
• Skin Hydration (Corneometer):
applying the product, allowing for an understanding of how the
product hydrates the skin right after use.
Moisturizing
Immediate hydration effect after PRIMARY
OBJECTIVE
• TEWL (Tewameter)
|