| CTRI Number |
CTRI/2024/03/064059 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see if the product makes your skin appear younger |
|
Scientific Title of Study
|
To evaluate the efficacy of the test product in providing Anti- Ageing Benefits in Healthy Human Volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/ICAG/2023-02 version 1.0, dated 20 Feb 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Department of Skin Sciences
327/15, 1st Main Road, Cambridge layout, Ulsoor, Bangalore.
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
|
| Email |
mukesh.ramnane@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Department of Skin Sciences
327/15, 1st Main Road, Cambridge layout, Ulsoor, Bangalore.
Bangalore
KARNATAKA
560008
India |
| Phone |
09620621625 |
| Fax |
|
| Email |
mukesh.ramnane@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Department of Skin Sciences
327/15, 1st Main Road, Cambridge layout, Ulsoor, Bangalore.
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
|
| Email |
mukesh.ramnane@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Ichimaru Pharcos Co Ltd.,
318-1 Asagi, Motosu-Shi
Gifu 501-0475
Japan. |
|
|
Primary Sponsor
|
| Name |
Ichimaru Pharcos Co Ltd |
| Address |
318-1 Asagi, Motosu-Shi
Gifu 501-0475
Japan. |
| 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 Mukesh Ramnane |
MS Clinical Research Pvt Ltd |
Department of Skin Sciences
327/15, 1st Main Road, Cambridge layout, Ulsoor, Bangalore.
Bangalore
KARNATAKA |
08041125934
mukesh.ramnane@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICOM Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy male and female participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Vegan Proteoglycan Essence |
Twice a day, to be applied for 4 weeks for the entire face |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects in the age group of 20-55 years (both ages inclusive).
2. Subject presenting at least 2 well defined dark spots of PIH/Acne/Age spots on either side of the face.
3. Subject identified for fine lines of score 4 and above and wrinkles of score 2 and above
4. Subjects with skin phototype III to V. (10% of the subjects to be phototype V).
5. Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face as determined by the dermatologist.
6. Subject who agrees not to use any other product/treatment/home remedy/ except the provided product on their face during the study period other than the test product.
|
|
| ExclusionCriteria |
| Details |
1.Subject with any other signs of significant local irritation or skin disease.
2. Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.
3. Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.
4. Subjects undergoing any treatment of any skin condition on their face.
5. Subjects not willing to discontinue other topical facial products.
6. Subject allergic or sensitive to bar, cleansing products, cosmetics, creams/lotions, artificial jewelry or anything else.
7. Subjects who are pregnant and lactating (Self- declared).
8. Subject who has participated in a similar clinical investigation in the past one month.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in skin firmness or elasticity in comparison to baseline at different timepoints.
2. Improvement in Wrinkles, Fine lines and Post Inflammatory Hyperpigmentation (Dark Spots) in comparison to Baseline at different timepoints.
3. Improvement in hydration in comparison to untreated site and Baseline at different timepoints
4. Improvement in the skin color in comparison to baseline at different timepoints. |
Baseline, 72hours, week 2 and week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate dermatological safety and tolerability of the test product for the entire study duration
|
Baseline, 72hours, week 2 and week 4 |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/03/2024 |
| Date of Study Completion (India) |
06/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
This
study aims to evaluate the efficacy and safety of a test product in reducing
signs of aging, such as wrinkles and spots, over a 4-week period in healthy
male and female volunteers. A total of 38 subjects will be screened. Upon
enrolment, subjects will undergo baseline assessments including dermatological
evaluation and instrumental assessments, followed by self-assessment. Throughout the study, subjects will apply the
test product twice daily and will attend assessment visits at 72 hours, week 2,
and week 4. Compliance will be monitored, and assessments will include
dermatological evaluations, instrumental assessments, and self-assessment. |