| CTRI Number |
CTRI/2025/09/094644 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
moisturization activity of Deep Revitalise Balanced Barrier Creme- Sensitive Skin |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the moisturization potential of Deep Revitalise Balanced Barrier Creme- Sensitive skin |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT841 Version 1.0 dated 14 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
|
| CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road, Meerut, UTTAR PRADESH-250005 |
| Honasa Consumer Limited, Cyberscape, Sector 59, Gurugram, Haryana 122102 |
|
|
Primary Sponsor
|
| Name |
Honasa Consumer Limited |
| Address |
Cyberscape, Sector 59, Gurugram, Haryana 122102 |
| 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: |
Test Product: Deep Revitalise Balanced Barrier Creme- Sensitive skin, Dose: Gently massage approx. 1 gm
Moisturizer over the face for 7 days, Daily as part of night time skincare. Route of
Administration: Topical |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1) Gender: Male or Female with age 20-35.
2) Subjects having Sensitive Skin only.
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) Are free of any systemic or dermatologic disorder, which, in
the opinion of the investigator, will interfere with the study
results or increase the risk of adverse events.
6) 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. Have any evidence of systemic cancer, squamous cell carcinoma, basal
cell carcinoma, in the last 5 years, or any other confounding skin
condition.
3. Have open sores or open lesions in the treatment area(s).
4. Have any condition that, in the opinion of the investigator, would
confound the safety and efficacy assessments of the
product.
5. Have participated in any interventional clinical trial in the previous 90
days.
6. Have a known sensitivity to any of the constituents of the test product.
7. Have used, are using, or are planning to use
immunosuppressive or immunomodulatory medication (i.e.,biologics),
including corticosteroids.
8. Have not skin related issues |
|
|
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 TEWL
3. IR ianging |
At T0min, T30min, T1 day and T7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
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="7" |
|
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 at marked Test product box and no product at the other box. Assessment Time: (Day 0 (T0min, T+30 mins) Day 1 and Day 7)
Assessments: - Skin Hydration with Corneometer (Day 0 (T0min, T+30 mins) Day 1 and Day 7) - TEWL with Tewameter (Day 0 (T0min, T+30 mins) and Day 7) - IR imaging and sensitivity Score (0-4) (Day 0 (T0min, T+30 ) - Erythema Index with Mexameter- redness (Day 0 and Day 7)
|