| CTRI Number |
CTRI/2025/08/092676 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Anti-Pigmentation Activity of Terrai Aqua Radiance Sunscreen |
|
Scientific Title of Study
|
A Clinical study to evaluate the Anti-Pigmentation Activity of Terrai Aqua Radiance Sunscreen |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT724 Version 1.0 dated 23 Jun 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 |
9027285265 |
| 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 |
8937015757 |
| 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 |
8937015757 |
| 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 |
| Terrai Natural products pvt ltd, 833, Udyog Vihar Phase V Rd, Phase V, Udyog Vihar, Sector 19, Gurugram, Haryana 122016 |
|
|
Primary Sponsor
|
| Name |
Terrai Natural Products Pvt Ltd |
| Address |
833, Udyog Vihar Phase V Rd, Phase V, Udyog Vihar, Sector 19, Gurugram, Haryana 122016 |
| 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, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH |
9027285265
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: Aqua Radiance Sunscreen SPF50 |
Test Product: Aqua Radiance Sunscreen SPF50, Dose: :1-1.5 gm twice in a day Route of Administration: Topical |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Gender: Male and Female Non-pregnant, non-lactating female aged between 25 and 55.
2. Subject with Hyperpigmentation (Dark spots, uneven skin tone)
3. Subject willing to give written informed consent
4. Women of child bearing potential must have a negative urine pregnancy test.
5. 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.
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. Volunteers with skin conditions such as eczema, psoriasis, etc
3. Have any evidence of systematic cancer, squamous cell carcinoma, basal cell carcinoma in the last 5 years, or any other confounding skin condition.
4. Have open sore or open lesions in the treatment area
5. Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
6. Have participated in any interventional clinical trial in the previous 30 days.
7. Have a known sensitivity to any of the constituents of the test product including sensitivities to any of the constituents.
8. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medications (i.e., biologics), including corticosteroids.
9. 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 Dark spots & Pigmentation
2. Change in Wrinkle count
3. Change in Melanin Index
4. Change in skin lightness
5. Change in skin Elasticity
6. Change in TEWL |
At Day0, Day 14, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in Hyperpigmentation
Change in Dark circles |
Ay Day0, Day14, Day28
|
|
|
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)
|
20/08/2025 |
| 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. Each participant entering the trial will be assigned to a regimen of investigational product.
Day 0 (T0) - Baseline Measurements: 1. Skin Gloss (Glossymeter): (0, 14, 28 days) 2. Skin Lightness (Spectrophotometer): (T0, 30min, 14, 28 days) 3. TEWL (Tewameter): (0, 14, 28 days) 4. Skin Pigmentation (Melanin Index) (Mexameter): (0, 14, 28 days) 5. Dark Spots (Visioface): (0, 14, 28 days) 6. Wrinkle count : (0, 14, 28 days) 7. HD Imaging with DSLR: (0, 28 days) 8. Visioscan Imaging: (0, 28 days)
Test Product: Terrai Aqua Radiance Sunscreen 
Dose: :1 gm twice in a day Route of Administration: Topical
|