| CTRI Number |
CTRI/2025/01/079296 [Registered on: 23/01/2025] 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
|
checking the effect of product on Skin |
|
Scientific Title of Study
|
The objective of this study is to evaluate the non-comedogenic effect of skin care formulation, skin lightening face serum, on healthy human female subjects. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-2F07-SN-DR24; Version: 01; Dated: 31/12/2024 |
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
|
| 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, CTS No. 201 B/1,
Western Express Highway,
Goregaon (East), Mumbai,
Maharashtra (India) – 400063
|
|
|
Primary Sponsor
|
| Name |
Sun Pharmaceutical Industries Ltd. |
| Address |
Sun House, CTS No. 201 B/1,
Western Express Highway,
Goregaon (East), Mumbai,
Maharashtra (India) – 400063
|
| 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 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 |
| Suraksa- Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with oily or mixed oily skin on the face and having mild to moderate acne(L70.8: Other acne (includes types not specifically classified)) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
None |
| Intervention |
Skin Lightening Face Serum |
Product is applied on whole face once in a day for the period of 28 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1)Indian female subjects
2Healthy subjects
3)Skin is healthy on the studied anatomic unit 4)Having oily or mixed oily skin type on the face.
|
|
| ExclusionCriteria |
| Details |
1 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.
13 Having changed her cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Non-comedogenic effect |
Baseline, Day 14, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/01/2025 |
| Date of Study Completion (India) |
25/02/2025 |
| 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)
|
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
|
OBJECTIVE: The objective of this study is to evaluate the non-comedogenic effect of skin care formulation, skin lightening face serum, on
healthy human female subjects.
The
evaluation is performed using: Dermatologist Evaluation Efficacy: (Counting of total
lesions ), Sebumetry, Subject Self
Evaluation (SSE) Questionnaire (Comedogenic Effect &
Safety), Subject
Self Evaluation (SSE) Questionnaire (Cosmetic
Appeal), Dermatological
Evaluation: Safety
-
Enrollment:
36 female subjects
-
Completed:
30 female subjects
The
subjects selected for this study are healthy females, aged between 18 and 35 years,
presenting with
oily or mixed oily skin on the face and
presenting with mild to moderate acne.
STUDY DURATION: Duration: 28 days following the first application of the
product. |