| CTRI Number |
CTRI/2023/06/054574 [Registered on: 30/06/2023] Trial Registered Prospectively |
| Last Modified On: |
28/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceutical] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety evaluation of Skin care formulations |
|
Scientific Title of Study
|
Evaluation of irritation potential of Skin Care formulations on healthy human subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q17-MW-AL23: Version: 01; Dated: 21/04/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raji Patil |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| MASCOT-SPINCONTROL India Pvt. Ltd. , 3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai 400013, MAHARASHTRA India |
|
|
Primary Sponsor
|
| Name |
Mosaic Wellness Private Limited |
| Address |
MOSAIC WELLNESS PRIVATE LIMITED,7th floor, Skyline icon, Chimatpada,Marol, Andheri, Mumbai-400059. |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Raji Patil |
Mascot Spincontrol India Pvt. Ltd. |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai 400013
Mumbai
MAHARASHTRA |
02243349191
raji@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethos- An Institutional Ethics committee (Mumbai) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1% Kojic Acid Lotion SPF 30 (NJ3027): Product B |
Approximately 0.04 ml (40 μl) of test product will be transfer on Aluminium Finn Chamber with the loaded product will then be taped onto the back of subjects for 24 hours. This is a single application and the occluded patch is removed after 24 hours. |
| Comparator Agent |
Negative Control (0.9% Isotonic saline solution) |
40ul of 0.9% Isotonic Saline Solution is transferred on Aluminium Finn Chamber. The Finn chamber with the loaded product will then be taped onto the back of subjects for 24 hours. This is a single application, and the occluded patch is removed after 24 hours. |
| Comparator Agent |
Positive Control (1% w/w SLS) |
1% Solution of SLS is prepared in distilled water and is dispensed in the aluminium chamber of the patch and applied on the back of the volunteers at T0 visit for 24 hours. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Sunscreen Lotion with SPF 50 (NJ3026): Product A |
Approximately 0.04 ml (40 μl) of test product will be transfer on Aluminium Finn Chamber with the loaded product will then be taped onto the back of subjects for 24 hours. This is a single application and the occluded patch is removed after 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.The study will be conducted on subjects who will fulfil the following criteria:
Standard criteria
2.Asian Indian male and female subjects.
3.Healthy human subjects (no infectious and evolutive pathology which could make the subject
vulnerable and stop the study, no pathology which could interfere with the study, no symptom in
the process of an exploratory check-up)
4.Between 18 and 65 years of age.
5.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) |
|
| ExclusionCriteria |
| Details |
1.Standard criteria
-For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
-Having refused to give his/her assent by not signing the consent form.
-Taking part in another study liable to interfere with this study.
-Being diabetic.
-Being asthmatic.
-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).
-Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
-Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
-Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months.
-Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
-The day of the patch application: no cosmetic product must be used (test site clean with water only).
2. Refusing to follow the restrictions below during the study:
- For female: Do not become pregnant nor breastfeed. - Do not take part in another study liable to interfere with this study.
- Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, and antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
- Do not change his/her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit.
3.Specific criteria
-Having eczema, psoriasis, lichen plan, vitiligo whatever the considered area.
-Having disorder of the healing (whatever the considered area)
-Having a rhinitis, allergic conjunctivitis or rhino sinusitis
-Having an allergy to perfumes and/or preservatives in cosmetic products.
-Having an allergy to plaster
-Having a food allergy
-Having a cardiovascular pathology (taking a beta blocker treatment)
-Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
-Taking a retinoid-based treatment by general or oral route
-Taking specific treatment on the back.
-Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study
-Having miliaria (prickly heat) on the back. • Presenting too many naevus on the back • Having high pilosity on the back.
4.Refusing to follow the restrictions below during the study:
- During the first 24 hours (after patch application), neither cosmetic products nor water must be applied on the back.
- Till the follow up period of until T8 days, only water is accepted from the first reading i.e., T2 days (24 hours after the patch removal).
- Do not practice an intensive sport activity during the first 24 hours (until the removal of the patches)
- Do not expose the back to the sun.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dermatological safety / Irritation potential on skin |
Baseline, 0 hr , 24 hours & day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
07/07/2023 |
| 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="8" |
|
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: To evaluate the irritation potential on healthy human subjects of Skin Care Formulations. Duration of study: 8 days study Kinetics: T0 (Evaluation of test sites by Dermatologist, Patch application) T1(Patch removal, Evaluation of test sites by Dermatologist T2(Evaluation of test sites by Dermatologist and Subject post 24 hrs of patch removal), T8 (Evaluation of test sites by Dermat and Subject post 1 week of patch removal and tracking the positive cases) Population: 26 healthy subjects (13 males + 13 females) The test area is checked for erythema and oedema caused due to the products and compared with positive control. |
|