| CTRI Number |
CTRI/2026/03/106712 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study to Evaluate a Skin Care Product for Improving Skin Hydration, Glow, Elasticity, and dark spots. |
|
Scientific Title of Study
|
To evaluate the safety and efficacy of skin care formulation in terms of skin hydration, skin water barrier, glow, firmness, elasticity, brightness and dark spots on healthy male and female subjects. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-HF02-IW-FR26; Version: 01; Dated: 09/03/2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Niharika Salian |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
niharika@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niharika Salian |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
niharika@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bio Veda Farmacy Private Limited
First Floor, Khasra No. 439/42,441/43,526/442/43,
Mauja Rampur Ghat,
Sirmaur, Himachal Pradesh, 173025
|
|
|
Primary Sponsor
|
| Name |
Bio Veda Farmacy Private Limited |
| Address |
First Floor, Khasra No. 439/42,441/43,526/442/43,
Mauja Rampur Ghat,
Sirmaur, Himachal Pradesh, 173025
|
| Type of Sponsor |
Other [Personal Care or Beauty Industry] |
|
|
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 Niharika Salian |
Mascot Spincontrol India Pvt. Ltd. |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
02243349191
niharika@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethos- Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
having dull skin with visible wrinkles, fine lines, and dark spots |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Morning Nectar Moisturizing Lotion |
Product is applied on the whole face one times in a day for the period of 28 days. |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Indian male & female subjects
2.Healthy subjects
3.Skin is healthy on the studied anatomic unit
4.Having dull skin with visible wrinkles, fine lines, dark spot
|
|
| ExclusionCriteria |
| Details |
1 For female:- Being pregnant or breastfeeding or having stopped to breastfeed in
the past three months
2 Having refused to give her assent by not signing the consent form
3 Taking part in another study liable to interfere with this study
4 Being insulin-dependent diabetic or non-insulin-dependent diabetic
with a recent therapy (less than 6 months)
5 Having a progressive asthma (either under treatment or last fit in
the last 2 years)
6 Having a chronic dermatosis liable to modify the cutaneous
reactivity on the tested area (except for specific studies on a
determined dermatosis)
7 Having non stabilized thyroid problems (requirement of a stabilized
treatment for at least 6 months)
8 Being epileptic.
9 Following a chronic medicinal treatment comprising any of the
following products: aspirin-based products, anti-inflammatories,
antihistamines, corticotherapy, taken by general or local routes (the
only medication permitted is paracetamol)
10 Having cutaneous hypersensitivity.
11 Having a diagnosed or highly probable allergy to one or several
compounds of the cosmetic products.
12 Having undergone a surgery requiring a general anaesthetic of
more than one hour in the past 6 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| skin hydration, skin water barrier, glow, firmness/elasticity, brightness, dark spots |
Baseline, 30 minutes after application, 8 hours after application, Day 1, day 7, Day 14, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| skin softness & smoothness, dark spot density, brightness, wrinkles, fine lines |
baseline, 30 minutes after application, 8 hours after application, Day 1, day 7, Day 14, Day 28 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
31/03/2026 |
| 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="3"
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
|
· Primary Objective The objective of this study is to evaluate the safety and efficacy of skin care formulation in terms of skin hydration, skin water barrier, glow, firmness/elasticity, brightness, acne PIH spots, on healthy male and female subjects. · Secondary Objective Secondary objective is to evaluate the in-vivo efficacy of a skin care formulation in terms of skin softness & smoothness, dark spot density, brightness, wrinkles, fine lines on healthy male and female subjects. The evaluation will be performed using: Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Chromametry, Tewametry, Corneometry, Glossymetry, Mexametry, Cutometry, Dino-lite, Antera 3D, Digital Photographs 36 (18 males & 18 females) will be selected for the study. The subjects selected for this study will be healthy male & females, aged between 25 and 50 years, having dull skin with visible wrinkles, fine lines, and dark spots. Duration: 28 days following the first application of the product.
|