| CTRI Number |
CTRI/2025/09/094638 [Registered on: 11/09/2025] 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
|
1% Hyaluronic Sunscreen Aqua Gel for plumper-looking skin, and reduction in skin dryness |
|
Scientific Title of Study
|
An open-label clinical study to check the efficacy of 1% Hyaluronic Sunscreen Aqua Gel on hydration, plumper-looking skin, and reduction in skin dryness in healthy volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT803 Version 1.0 dated 21 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 |
| THE DERMA CO., Capital Cyberscape Gurugram |
|
|
Primary Sponsor
|
| Name |
THE DERMA CO. |
| Address |
Capital Cyberscape Gurugram |
| 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: 1% Hyaluronic Sunscreen Aqua
Gel |
Route of administration: Topical, Frequency :gently apply 1gm of the gel and massage in outward direction, Duration: 1day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Gender: Non-pregnant, non-lactating female Age 18–55 years.
2. Subject willing to give written informed consent
3. Women of child bearing potential must have a negative urine pregnancy test
4. Fitzpatrick skin type II–V.
5. Healthy skin on test areas.
6. Agree to avoid other facial actives 7 days prior to visit.
|
|
| ExclusionCriteria |
| Details |
1. Subjects who are pregnant, breast feeding, or planning to become pregnant during the study
2. Have any evidence of systematic cancer, squamous cell carcinoma, basal cell carcinoma in the last 5 years, or any other confounding skin condition.
3. Have open sore or open lesions in the treatment area
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 30 days.
Known allergy to product ingredients.
6. Active dermatitis, wounds or lesions on test areas.
7. Facial procedures in prior 4 weeks (e.g., peels, lasers).
8. Systemic retinoids in prior 6 months.
|
|
|
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. DSLR Imaging
3. Dermatologist visual grading
|
At T0, 30 minutes, 2 hour and 8 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. SGA |
At T0, 30 minutes, 2 hour and 8 hours |
|
|
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)
|
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="1" |
|
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
|
An Open Label clinical study within subject pre-post application Assessments Test Area- face, No of volunteers- 36 Age- 18-55years
Assessments: 1. Corneometer- for hydration 2. DSLR imaging- full face and closer with plumer skin imaging 3. Clinical and visual assessments 4. Dermatologist visual grading 0-3 scale 5. Subjective and Sensory Assessments 6. Immediate sensory Questionnaire
Dose and application- Adequate amount applied uniformly on face Time Points: 0min, 30min, 2hrs and 8hrs
|