| CTRI Number |
CTRI/2025/07/090872 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of an Under-Eye Cream Containing Retinol and Pycnogenol for Reducing Dark Circles in Adults Aged 18 to 60 Years Over 16 Weeks |
|
Scientific Title of Study
|
Evaluation of an Under-Eye Cream: Open-label Single Arm Interventional Prospective Study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.T. Vanathi |
| Designation |
Consultant Dermatologist |
| Affiliation |
Render Skin and Hair |
| Address |
Render Skin and Hair,Canberra House, 97, Pantheon Road, Egmore, Chennai
Chennai
TAMIL NADU
600008
India |
| Phone |
9884748215 |
| Fax |
|
| Email |
drvanathi@renderclinic.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.T.Vanathi |
| Designation |
Consultant Dermatologist |
| Affiliation |
Render Skin and Hair |
| Address |
Render Skin and Hair,Canberra House, 97, Pantheon Road, Egmore, Chennai
TAMIL NADU
600008
India |
| Phone |
9884748215 |
| Fax |
|
| Email |
drvanathi@renderclinic.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.T.Vanathi |
| Designation |
Consultant Dermatologist |
| Affiliation |
Render Skin and Hair |
| Address |
Render Skin and Hair,Canberra House, 97, Pantheon Road, Egmore, Chennai
TAMIL NADU
600008
India |
| Phone |
9884748215 |
| Fax |
|
| Email |
drvanathi@renderclinic.com |
|
|
Source of Monetary or Material Support
|
| Silphion Research Private Limited,44, 1st Main Rd, Gandhi Nagar, Adyar, Chennai, Tamil Nadu 600020 |
|
|
Primary Sponsor
|
| Name |
Silphion Research Private Limited |
| Address |
44, 1st Main Rd, Gandhi Nagar, Adyar, Chennai, Tamil Nadu 600020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrTVanathi |
Render Skin and Hair |
Canberra House, 97, Pantheon Rd, Egmore, Chennai, Tamil Nadu 600008
Chennai
TAMIL NADU |
9884748215
drvanathi@renderclinic.com |
|
|
Details of Ethics Committee
|
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Peri orbital Melanosis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Open Label Single Arm Interventional Prospective Study |
An Under eye cream will be given to all the participants
Night-time Use:
Make sure the skin is clean and dry before application.
The cream should be applied 20 minutes after cleansing the skin.
Apply a small amount of Under eye cream around the eyes every night before bed for 16 weeks continuously
Dab gently with your ring finger – do not rub or massage harshly.
Avoid getting the cream into your eyes.
Morning Care:
Mandatory: Apply a broad-spectrum sunscreen (SPF 40/ PA+++) every morning to the entire face, including the under-eye area.
Sunscreen should be applied 30 minutes before sun exposure and re-applied if outdoors for extended periods.
Sunscreen use is essential throughout the 16-weeks study period, even on cloudy days or indoors near windows.
Regular Application:
Apply the cream consistently every night without skipping.
Do not use any other under-eye creams, brightening agents, or treatments during the study unless instructed by the principal investigators.
If dryness arises, soothing moisturizers will be given.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)18–60 years
2)Visible under-eye pigmentation
3)Consent to participate
4)Comply with follow-up schedule
|
|
| ExclusionCriteria |
| Details |
1)Recent use of topical depigmenting agents on the face(past 4 weeks)
2)Known allergy to any ingredient in the cream
Ongoing dermatological or systemic illness affecting the face
3)Pregnant or lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the pigmentary, vascular or mixed type of peri orbital hyperpigmentation
|
Day 0, Week 4,8,12 & 16
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate participant-reported outcomes, including self-assessed wrinkle improvement and satisfaction with the appearance of their under-eye area.
|
Day 0, Week 4,8,12 & 16
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/07/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This open-label, single-arm, 16-week clinical trial evaluates an under-eye cream containing retinol and pycnogenol in 30 participants aged 18–60 with visible under-eye pigmentation. The cream is applied nightly, alongside daily SPF 40 sunscreen. Assessments include clinical photos, Reveal® imaging, and Dermalab biophysical measurements every 4 weeks. Participants will avoid other under-eye treatments, and adverse events will be monitored and managed. Data will be securely stored with participant confidentiality maintained. |