| CTRI Number |
CTRI/2025/08/093104 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to assess the safety and effectiveness of the product on human volunteers |
|
Scientific Title of Study
|
To evaluate the in vivo safety and efficacy of a skin care formulation in terms of Skin Brightening, skin even tone, skin smoothness, softness and reduction in intensity of acne PIH on healthy human subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-NF02-3M-AL25; Version: 01; Dated: 25/07/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Yadav |
| 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 |
poojayadav@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Yadav |
| 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 |
poojayadav@mascotspincontrol.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr. Ruchi Srivastava |
| Designation |
Medical Affairs & Clinical Research |
| Affiliation |
Multani Pharmaceuticals Limited |
| Address |
Khasrano 37, Bhagwanpur, Roorkee, Makkanpur Mehmood Alam, Haridwar, Uttarakhand, India
Hardwar
UTTARANCHAL
247661
India |
| Phone |
96543-50714 |
| Fax |
|
| Email |
dr.ruchi@multani.org |
|
|
Source of Monetary or Material Support
|
| Multani Pharmaceuticals Limited Khasrano 37, Bhagwanpur, Roorkee, Makkanpur Mehmood Alam, Haridwar, Uttarakhand, 247661 |
|
|
Primary Sponsor
|
| Name |
Multani Pharmaceuticals Limited |
| Address |
Khasrano 37, Bhagwanpur, Roorkee, Makkanpur Mehmood Alam, Haridwar, Uttarakhand, 247661 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Pooja Yadav |
Mascot Spincontrol India Pvt. Ltd. |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
02243349191
poojayadav@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 wheatish to dark complexion, having acne PIH at least one spot of 3mm or more |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
Serum |
The product is applied on the whole face two times in a day for the period of 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Indian or Asian female subjects
2.Healthy subjects
3.Skin is healthy on the studied anatomic unit
4.Having wheatish to dark complexion.
5.Having acne PIH at least one spot of 3mm or more |
|
| ExclusionCriteria |
| Details |
1. Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2. Having refused to give her/his 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,
anti-histamines, 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 anesthetic 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 Brightening, skin even tone, skin smoothness, softness and reduction in intensity of acne PIH |
Baseline, 30 minutes, 7 days,14 days, 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
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)
|
24/08/2025 |
| 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
|
OBJECTIVE: The objective of this study
will be to evaluate the in-vivo safety & efficacy of a Skin Care Formulation
in terms of Skin Brightening, skin even tone, skin smoothness, softness and
reduction in intensity of acne PIH on healthy human subjects coded:
The
evaluation is performed using: Subject Self Evaluation, Dermatological
Evaluation: Cosmetic Acceptability, Dermatological Evaluation by a
Dermatologist (Efficacy) , Chromametry, Mexametry
POPULATION:36 female subjects be selected for the study.
The subjects selected for this study will be healthy females, aged between 18
and 45 years old, having wheatish to dark complexion, having acne PIH at
least one spot of 3mm or more.
STUDY DURAN: 28 days following the first application of the product. |