| CTRI Number |
CTRI/2025/11/097635 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to test the effectiveness of the test product in reducing age related signs like dark spots and fine lines. |
|
Scientific Title of Study
|
Anti-Aging Efficacy of the test product in improving skin biophysical properties – a clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/HUAG/2025-66 Version 1.0 24 Oct 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anusha S |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
Department of Skin Sciences,
#324, Second Floor,
1st Main Road, Cambridge Layout,
Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
anusha.shivaswamy@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritambhara |
| Designation |
Director - Business and Operation |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
ritambhara@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudhanthiran S |
| Designation |
Manager - Techno-commercial |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
sudhan@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Hindustan Unilever Limited,
Unilever House, B.D. Sawant Marg, Chakala,
Mumbai- 400 099
|
|
|
Primary Sponsor
|
| Name |
Hindustan Unilever Limited |
| Address |
Unilever House,
B.D. Sawant Marg, Chakala, Mumbai- 400 099 |
| Type of Sponsor |
Other [FMCG (Fast Moving Consumer Goods)] |
|
|
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 |
| Dr Anusha S |
MS Clinical Research Pvt. Ltd |
Department of Skin Sciences,
#324, Second Floor,
1st Main Road, Cambridge Layout,
Ulsoor
Bangalore
KARNATAKA |
08040917253
anusha.shivaswamy@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwara Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Female trial participants with Skin Aging signs |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cosmetic product SA22 |
Participants will be asked to apply the product twice daily for 8 weeks |
| Comparator Agent |
Nil |
N/A |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Female adult trial participants in general good health as determined from a recent medical history and dermatological examination.
2. Trial participants in the age group of 40-60 years
3. Trial participants showing signs of aging on skin like fine line, crow feet
4. Trial participants with dark spots
5. Trial Participants agreeing to adhere to study protocol requirements and restrictions
|
|
| ExclusionCriteria |
| Details |
1. Trial participant who are pregnant, lactating or nursing (self-declared)
2. Trial participants who have used any skincare products in last one month before this study.
3. Trial participants who have participated in any clinical study involving facial test sites within the past 6 months
4. Trial participants with current or past history of any dermatological condition on the face
5. Trial participants currently taking any medication.
6. Trial participants who have any visible cuts, abrasions, or open wounds on the treatment area
7. Participants on any food supplements for skin or hair benefits or others.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Texture, Hydration, Barrier strength |
Baseline, Week 4 and Week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety assessments like redness and dryness |
Baseline, Week 4 and Week 8 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/12/2025 |
| 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="2"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Participants are recruited based on inclusion and exclusion criteria and undergo 7 days of washout period. On Day 1 baseline (instrumental & dermatological) assessments are done. Participants are provided with test product for application on the face and instructed to apply on face twice a day. All instrumental and dermatological visual assessments were done at Baseline, week 4 and Week 8. |