| CTRI Number |
CTRI/2025/07/090493 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of test product in reducing wrinkles and making facial skin smooth and glowing in women. |
|
Scientific Title of Study
|
A monocentric, single group, 12 week trial to evaluate the benefits of a serum in reducing expression lines, improving texture and radiance of facial skin in women and its in use tolerance.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/049/0525/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
Mumbai
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 with wrinkles will be included in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FirmX 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 90 days. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Voluntary women from 30 years to 65 years of age.
2. Volunteers with expression lines (nasolabial folds, forehead wrinkles, wrinkles &fine lines in
crow’s feet area, marionette lines, undereye wrinkles & Fine lines).
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 expression lines (nasolabial folds, forehead wrinkles, wrinkles &fine
lines in crow’s feet area, marionette lines, undereye wrinkles and Fine lines)
2. 3D Imaging for skin texture (skin smoothness).
3. Skin radiance using Glossmeter.
4. Self-assessment for product efficacy. |
Day 0, Day7, Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Clinical evaluation for in-use skin tolerance.
2. Self-assessment questionnaire for in use tolerance. |
Day7, Day 90 |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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="1"
Months="0"
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
|
Argireline can help increase collagen production. Increased collagen production can result in plumper-looking skin and improved skin elasticity, leading to reduced visible wrinkles. Topical niacinamide provides benefits on skin such as , improving appearance of texture, hyperpigmentation, and red blotchiness. In addition, it also helps in improvement in wrinkles, firmness (elasticity), and sallowness (yellowing).Niacinamide and Phytic acid also gives a skin brightening effect. FirmX, which contains all the above mentioned ingredients is claimed to reduce the appearance of expression lines, improve skin texture and skin radiance. This purpose for this study is to evaluate the benefits of the serum objectively by using 3D imaging and skin GlossMeter and subjectively by self-assessment questionnaire |