| CTRI Number |
CTRI/2025/02/080265 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluation of skin benefits of the test products |
|
Scientific Title of Study
|
A study to evaluate the efficacy of test products in providing skin benefits like moisturization, anti-aging, exfoliation and brightening benefits among healthy female participants. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/IVSS/2024-01 version 1.0 dated 24 Dec 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical research |
| Address |
MS Clinical Research Pvt. Ltd
Department of Skin Sciences,324 Second floor, 1st main road, cambridge layout, ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritambhara Kumari |
| Designation |
Director-Business and operations |
| Affiliation |
MS Clinical research |
| Address |
MS Clinical Research Pvt. Ltd
Department of Skin Sciences,324 Second floor, 1st main road, cambridge layout, ulsoor
Malad West
Bangalore
KARNATAKA
400064
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 |
MS Clinical ReseaDepartment of Skin Sciences,324 Second floor, 1st main roa, cambridge layout, ulsoorrch Pvt. Ltd
Bangalore
KARNATAKA
Dr Mukta Sachdev
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
sudhan@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Innovantase Research and Development Services LLP
Wintergreen C25
Dattapada Road
Mumbai 400066
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Innovantase Research and development services LLP LLP |
| Address |
Wintergreen C25
Dattapada Road
Mumbai 400066
Maharashtra
|
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Devipro Wellness Private Limited |
Wintergreen C25
Dattapada Road
Mumbai 400066
Maharashtra
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mukta Sachdev |
MS Clinical Research Pvt. Ltd |
324, second floor
Department of Skin Sciences
1st Main Road Cambridge Layout
Ulsoor
Bangalore
KARNATAKA |
08040917253
mukta.sachdev@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy female subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Night Cream (Anti-Aging Benefit) |
Frequency: once daily at night Method of application:
The participants will take the required quantity of test products -
1pump (approx. 1g) on their palm and will make small dots on the washed/clean dried face using the index finger.
The participants will be asked to spread the product uniformly with the help of four fingers using a circular motion for about 1 minute or till the product is fully absorbed.
|
| Comparator Agent |
Placebo |
Frequency: twice daily (morning and evening)
Method of application:
The participants will take the required quantity of test products -
1Pump (approx. 1g) on their palm and will make small dots on the washed/clean dried face using the index finger.
The participants will be asked to spread the product uniformly with the help of four fingers using a circular motion for about 1 minute or till the product is fully absorbed.
|
| Intervention |
Resurfacing Serum (AHA/BHA) |
Frequency: twice daily (morning and evening)
Method of application:
The participants will take the required quantity of test products -
1Pump (approx. 1g) on their palm and will make small dots on the washed/clean dried face using the index finger.
The participants will be asked to spread the product uniformly with the help of four fingers using a circular motion for about 1 minute or till the product is fully absorbed.
|
| Intervention |
Skin All-Purpose Cream (Deep Moisturization Benefit) |
Frequency: twice daily (morning and evening)
Method of application:
The participants will take the required quantity of test products -
1Pump (approx. 1g) on their palm and will make small dots on the washed/clean dried face using the index finger.
The participants will be asked to spread the product uniformly with the help of four fingers using a circular motion for about 1 minute or till the product is fully absorbed.
|
| Intervention |
Vit C brightening serum |
Frequency: twice daily (morning and evening) Method of application: The participants will take the required quantity of test products - 1Pump (approx. 1g) on their palm and will make small dots on the washed/clean dried face using the index finger. The participants will be asked to spread the product uniformly with the help of four fingers using a circular motion for about 1 minute or till the product is fully absorbed. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Healthy female subjects, as determined from a recent medical history.
2. Subjects in the age group of 35-60 years (both ages inclusive)
3. Subjects with all skin types (preferably in equal ratio).
4. Subjects with dull-looking skin.
5. Subjects who have not used retinol-based products minimum 8 weeks prior to enrollment (only for group 2).
6. Subjects with fine lines around the eyes (only for group 2)
7. Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
8. Subjects who agree not to use any other product/treatment/home remedy/soap bar on their face during the study period other than the test products.
9. Subjects must not be using any other skin-brightening products, or topical treatments during the study period (mandatory for group 4).
10. Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.
11. Subjects who agree not to expose to excessive sunlight. (Sun exposure not more than half an hour daily and during that time use of umbrella to cover face).
12. Subjects willing to give voluntary written informed consent and agree to come for regular follow-up.
|
|
| ExclusionCriteria |
| Details |
1. A known history or present condition of an allergic response to any cosmetic products.
2. Subject having active skin diseases (e.g., active atopic dermatitis, pigmented contact dermatitis or other cutaneous manifestations), which will interfere with the assessment.
3. Subjects who have sensitivity towards products containing AHA/BHA or Vit C or Retinol components.
4. Subjects had cancer in the last 10 years
5. Subjects with wounds, sunburn, scars, tattoos or piercings at the skin test site(s)
6. Subjects with application of ointments, creams etc. for antibacterial, anti-allergic or immunosuppressive treatment of the skin at the test site(s)
7. History of intense sun exposure and/ photo toxicity/allergy.
8. Female subjects who are pregnant, lactating or nursing.
9. Chronic illness which may influence the cutaneous state.
10. Subject participating in any other cosmetic or therapeutic trial.
11. Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) the deep moisturization benefit between groups as well as against the baseline,using dermatological and instrumental assessments.
2) the antiaging benefit between groups as well as against the baseline,using dermatological and instrumental assessments.
3) the exfoliation benefits between groups as well as against the baseline,using dermatological and instrumental assessments.
4) the brightening effect between groups as well as against the baseline,using dermatological and instrumental assessments.
|
baseline, weeks 1,2,4 and 8
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the efficacy of test products using subject self-assessment. |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
18/02/2025 |
| 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="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
|
The study is designed to evaluate the efficacy of test products in providing skin benefits like moisturization, anti-aging, exfoliation and brightening benefits among healthy female participants in comparison with the placebo and the baseline.
The participants who satisfy the inclusion-exclusion criteria will be enrolled after obtaining the informed consent form. 33 female participants in good general health, aged 35 to 60 years, will be screened and enrolled in the study. Participants will be asked to report for the assessment visit in the morning and should have taken a bath before coming for the assessments and without any product application in their face in the past 12-16 hours. The compliance will be checked by non-leading questions and visual assessment of the test area. The participants will be asked to wash their face with a neutral face wash and pat dry with paper towels. The participants will then acclimatize under a standard atmospheric condition for 15± 5 minutes prior to the baseline measurements by using dermatological and instrumental assessments. Similar assessements will be performed during the following visits throughout the study duration to determine the safety and efficacy of the test products in providing skin benefits like moisturisation, antiageing, exfoliation and skin brightening.
|