| CTRI Number |
CTRI/2026/03/106616 [Registered on: 20/03/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [cosmetic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Honasa Skin Renew Peptide Under Eye Cream for dark circle and ageing. |
|
Scientific Title of Study
|
A single blind clinical study to evaluate the activity of Honasa Skin Renew Peptide Under Eye Cream for dark circle and ageing. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT1372 Protocol Version 1.0 dated 26 Feb 2026 |
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, CAPITAL CYBERSPACE,11th Floor, Golf Course Ext Rd, Sector 59, Gurugram, Haryana 122101 |
|
|
Primary Sponsor
|
| Name |
Honasa Consumer Ltd. |
| Address |
CAPITAL CYBERSPACE,11th Floor, Golf Course Ext Rd, Sector 59, Gurugram, Haryana 122101 |
| 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-250005
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: Skin Renew Peptide Under Eye Cream |
Test Product: Skin Renew peptide Under eye Cream
Dose: : Gently apply the cream around eye area, Route of Administration: Topical, Duration: 14 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Gender Male and Female aged between 25-45.
2. Non-pregnant, non-lactating female
3. Subject with crow feet and dark circle.
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. 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 Skin Hydration (Corneometer)
2. Change in TEWL (Tewameter)
3. Change in Skin Melanin (Mexameter)
4. Change in Wrinkles (Visioface)
5. Change in Skin Firmness/Elasticity (Cutometer) |
Day 0, 24 hour(Hydration), Day 14
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Dermatological Evaluations
2. HD Imaging with DSLR
3. SGA |
Day0, Day14 |
|
|
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)
|
23/03/2026 |
| 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="14" |
|
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:
• Skin Hydration (Corneometer): Day 0, Day 1(for 24 hour check), Day 14) • TEWL (Tewameter): (0 and 14 days) • Skin Melanin(Mexameter): (0 and 14 days) • Wrinkles (Visioface): ((0 and 14 days)) • Skin Firmness/Elasticity(Cutometer Assessment): (0 and 14 days) • Dermatological Evaluations (5-Point Ordinal Scale,0-4): (0, 14days)
1. Dark circle severity Score ( Day 0 and Day 14)- with image 2. Eye puffiness Score ( Day 0 and Day 14) 3. Crow feet grading with Photonumeric Scale ( Day 0 and Day 14)- with image
• HD Imaging with DSLR: (0, 14 days) |