| CTRI Number |
CTRI/2025/10/095723 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Other |
|
Public Title of Study
|
Study to check if a makeup product is safe for people. |
|
Scientific Title of Study
|
Evaluation of the irritation potential of Lip Care Formulations on healthy human subjects having varied skin type |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q06-ZV-AT25; Version: 01; Dated: 28/08/2025 |
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
|
| G.D. Pharmaceuticals Pvt. Ltd. Asha Mahal, 94, N.R. Avenue, Kolkata 700053 |
|
|
Primary Sponsor
|
| Name |
G.D. Pharmaceuticals Pvt. Ltd. |
| Address |
Asha Mahal, 94, N.R. Avenue, Kolkata 700053 |
| 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 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 |
with varied skin type |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BOROLINE’S BO® LIPS BLACK CURRANT WITH ALMOND OIL (BB006) |
A Single application of about 0.04ml of product is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
BOROLINE’S BO® LIPS CARAMEL WITH ALMOND OIL (BL004) |
A Single application of about 0.04ml of product is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
BOROLINE’S BO® LIPS CHOCOLATE WITH ALMOND OIL (BC047) |
A Single application of about 0.04ml of product is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
BOROLINE’S BO® LIPS MANGO WITH ALMOND OIL (BM005) |
A Single application of about 0.04ml of product is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
BOROLINE’S BO® LIPS VANILLA WITH ALMOND OIL (BV044) |
A Single application of about 0.04ml of product is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
BOROLINE’S BO® LIPS STRAWBERRY WITH ALMOND OIL (BS048) |
A Single application of about 0.04ml of product is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Comparator Agent |
Negative Control (0.9% Isotonic saline solution) |
A single application of about 0.04ml of 0.9% Isotonic Saline, is applied under occlusion for 24 hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Comparator Agent |
Positive Control (1% w/w SLS) |
A single application of about 0.04ml of 1% SLS, prepared in distilled water is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy Human Subjects
2.Skin should be healthy on the studied anatomic unit
3)Subjects representing varied skin type types |
|
| ExclusionCriteria |
| Details |
1)For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
2)Having refused to give his/her assent by not signing the consent form.
3)Taking part in another study liable to interfere with this study.
4) Being diabetic.
5) Being asthmatic.
6) 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).
7)Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
8) Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
9) Having undergone a surgery requiring a general anesthesia of more than one hour in the past 6 months.
10) Having changed his/her cosmetic habits 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
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dermatological safety / Irritation potential on skin |
Baseline,0 hrs,24 hrs and 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
18/10/2025 |
| 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="0"
Days="9" |
|
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 irritation potential on healthy human subjects having varied skin of Lip Care Formulations Kinetics: T0(before patch application), T1 day (0 hour after the patch removal), T2 days (24 hours after the patch removal ), T8 days (T+1 week after 0 hour of patch removal) Population: 26healthy subjects (13 males + 13 females) . The test area is checked for erythema and oedema caused due to the products and compared with positive control |