| CTRI Number |
CTRI/2025/02/081287 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study for the assessment of product safety and effectiveness |
|
Scientific Title of Study
|
Evaluation of the Efficacy and In Use Safety of Skin Care Formulation in Female Subjects with Postinflammatory Hyperpigmentation |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-QF01-SN-DR24; Version: 01; Dated: 06/02/25 |
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 |
investigators@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 |
investigators@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
|
| Sun Pharmaceutical Industries Ltd.
Sun House, 201 B/1,
Western Express Highway,
Goregaon (East), Mumbai,
Maharashtra (India) – 400 063 |
|
|
Primary Sponsor
|
| Name |
Sun Pharmaceutical Industries Ltd. |
| Address |
Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, Maharashtra (India) – 400 063 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Mohit Lalvani |
Mascot Spincontrol India Pvt. Ltd. |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
02243349191
mohit.CTRI@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Suraksa- Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
having Fitzpatrick skin type III-V and having visible facial PIH |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
Skin Lightening Face Serum (BSLS-101224) |
The Product is applied on whole face once at night for the period of 84 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1)Indian female subjects
2)Having Fitzpatrick Skin type 3 to 5
3)Having facial PIH with at least one dark spot more than or equal to 3mm in diameter.
4)Willing to sign the informed consent form to participate in the study and to comply to the protocol and study procedures |
|
| ExclusionCriteria |
| Details |
1)Female who is pregnant or breastfeeding or has stopped breastfeeding in the past three months
2)Participating in another study liable to interfere with this study
3)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
4)Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
5)Having progressive asthma
6)Being epileptic
7)Having non stabilized thyroid problems
8_Having cutaneous hypersensitivity
9)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex
10)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) for more than 1 year.
11)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
12)Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
13)Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted).
14)Having started, changed or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy) in the past 3 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pigmentary intensity |
Baseline, Day 14, Day 28, Day 56 and Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety and cosmetic appeal |
Baseline, Day 14, Day 28, Day 56 and Day 84 |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
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)
|
01/03/2025 |
| 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="5"
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
Primary Objective:
To assess the efficacy of skin care formulation, skin
lightening face serum in female subjects with visible facial PIH.
Secondary Objective:
To assess the safety and cosmetic appeal of skin care
formulation, skin lightening face serum in female subjects with visible facial
PIH.
STUDY DESIGN
This is a non-comparative, prospective, interventional
study.
STUDY POPULATION
Enrollment: 128 subjects with facial PIH.
Completed: 115.
The subjects selected for this study are female
subjects of 18-40 years of age having Fitzpatrick skin type III-V and having
visible facial PIH (at least one spot of 3mm size).
STUDY DURATION
Screening period: 1 day
Treatment period: 84 days (i.e., 12 weeks) |