| CTRI Number |
CTRI/2025/06/089375 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
To study the anti-ageing effect of a test product in women. |
|
Scientific Title of Study
|
A monocentric, single group, 4 week trial to evaluate the skin anti-ageing benefits of a serum in women and its in use tolerance. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/041/0525/STU Version No.: 1 of 20th May 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator - Consultant Dermatologist |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD. |
| Address |
5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
rsjdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Preetha Paul |
| Designation |
Senior Manager - TQM |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD. |
| Address |
5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
preetha@claimsclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Preetha Paul |
| Designation |
Senior Manager - TQM |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD. |
| Address |
5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
preetha@claimsclinical.com |
|
|
Source of Monetary or Material Support
|
| Earthy Biome, 14, Navjeevan Vihar,
New Delhi – 110017 (India) |
|
|
Primary Sponsor
|
| Name |
Earthy Biome |
| Address |
14, Navjeevan Vihar,
New Delhi – 110017 (India) |
| Type of Sponsor |
Other [Cosmetic company] |
|
|
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 Rajiv Joshi |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.) |
5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA |
66758851
rsjdrs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLAIMS Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers will be included in the study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
PlumpX serum |
Face will be washed and dabbed dry with towel. A thin layer of serum
(approximately 0.5 ml) will be applied on face, by gentle massaging, twice daily-morning and night for a duration of 30 days. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Voluntary women from 35 years to 65 years of age.
2. Volunteers with mild to moderate wrinkles in crow’s feet area.
3. Having apparently healthy skin on test area.
4. Willingness to discontinue the use of other cosmetic products on face during the course of
the study.
5. Willing to avoid unusual sun exposure as far as possible for the entire study duration.
6. Accepting not to use products with the same end benefit during the entire study duration.
7. Cooperating, informed of the need and duration of the examinations, and ready to comply
with protocol procedures.
8. Ready to provide consent, having been informed orally and in writing of all information
concerning the study procedures and study objectives. |
|
| ExclusionCriteria |
| Details |
1. Female who is pregnant by UPT or lactating.
2. Any cutaneous conditions on test site (scars, moles, papules etc).
3. Participants hypersensitive to any of the components of the test product.
4. Participants having any hard damage to skin (e.g., excessive sunburn or suntan).
5. Participants on any systemic medical treatment which may interfere with the performance of
the study treatment (presently or in the past 1 month).
6. Participant in an exclusion period or participating in any clinical trial within 30 days prior to
screening. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. 3D Imaging for wrinkles, fine lines and texture.
2. Skin elasticity and firmness using CutoMeter.
3. Skin radiance using Glossmeter.
4. Self-assessment for product efficacy. |
Day 0, Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Clinical evaluation for in-use skin tolerance.
2. Self-assessment questionnaire for in use tolerance. |
Day 30 |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/06/2025 |
| Date of Study Completion (India) |
11/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Improvement in overall facial skin appearance is most rapidly achieved through enhanced moisturization. Moisturization occurs by increasing the water content of the epidermis, thereby improving skin texture and reducing the appearance of fine lines and superficial wrinkles. The skin naturally achieves hydration through dermal glycosaminoglycans (GAGs) such as hyaluronic acid PlumpX serum majorly consist of a complex of hyaluronates and rice extract which claim to have the benefits of skin hydration and prevention of Transepidermal water loss. In addition it also contains Lactobacillus/Soybean Ferment Extract which adds on to the effect of the hyaluronates. The objective of this study is to validate the claim of the ability of this facial serum to deliver skin benefits by promoting skin plumpness and hydration while minimizing fine lines/wrinkles and improving the overall facial appearance.
Result: The study was completed with 34 complete cases and no adverse events were reported during the study. |