| CTRI Number |
CTRI/2023/06/054003 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
03/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceutical] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The objective of this study will be to evaluate the dermatological safety of investigational products
through primary irritation patch test on healthy human volunteers with sensitive skin. |
|
Scientific Title of Study
|
To evaluate the dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of with sensitive skin |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q49-ZC-MY23: Version: 01; Dated: 08/06/2023 |
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 |
MASCOT-SPINCONTROL India Pvt. Ltd. Kohinoor Estate, 3rd Floor
Sun Mill Compound, Lower Parel – West
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 |
MASCOT-SPINCONTROL India Pvt. Ltd. Kohinoor Estate, 3rd Floor
Sun Mill Compound, Lower Parel – West
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 |
MASCOT-SPINCONTROL India Pvt. Ltd. Kohinoor Estate, 3rd Floor
Sun Mill Compound, Lower Parel – West
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
| MASCOT-SPINCONTROL India Pvt. Ltd. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower
Parel – West, Mumbai – 400013,MAHARASHTRA, INDIA |
|
|
Primary Sponsor
|
| Name |
ITC LIMITED ITC Life Sciences and Technology Centre |
| Address |
Peenya Industrial area, I Phase, Peenya Bengaluru, 560058,
Karnataka, India |
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
not applicable
|
|
|
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. |
MASCOT-SPINCONTROL India Pvt. Ltd.Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower
Parel – West
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 |
with sensitive skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% Isotonic Saline Solution -
Negative control
|
0.9% Isotonic Saline Solution is dispensed in the aluminium
chambers of the patch and
applied on the back of the
volunteers at T0 visit. This is a single application and the occluded patch is removed after 24 hours.
|
| Comparator Agent |
1% Sodium Lauryl Sulphate
(SLS) - Positive control |
1% Solution of SLS is prepared
in distilled water and is
dispensed in the aluminium
chambers of the patch and
applied on the back of the
volunteers at T0 visit. This is a
single application and the
occluded patch is removed after
24 hours.
|
| Intervention |
Leave on (14-133):Product A |
1:1 slurry solution of the investigational product will be prepared by weighing 5g of the product & dissolving it in 5 ml of distilled water. Mix it slowly to make uniform solution. Transfer 0.04ml (40 μl) of the test product solution to previously numbered Aluminium Finn Chamber with an appropriate sized disc of Whatman no. 3 filter paper with the help of Micropipette. The Finn chamber with the loaded product filter paper disc will then be taped onto the back of subjects for 24 hours and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (134-76A): Product D |
The product is rinse off product.8% w/w solution of the
investigational product is
prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the
patch and applied on the back
of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (169-40C): Product E |
The product is rinse off product.8% w/w solution of the
investigational product is
prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the
patch and applied on the back
of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (177-27): Product B |
The product is rinse off product.8% w/w solution of the
investigational product is
prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the
patch and applied on the back
of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (177-28): Product C |
The product is rinse off product.8% w/w solution of the
investigational product is
prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the
patch and applied on the back
of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (179 - 43): Product F |
The product is rinse off product. 8% w/w solution of the investigational product is prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (182-30): Product G |
The product is rinse off product.8% w/w solution of the
investigational product is
prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the
patch and applied on the back
of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (182-31): Product H |
The product is rinse off product. 8% w/w solution of the investigational product is prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (CN181-10): Product J |
The product is rinse off product.8% w/w solution of the
investigational product is
prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the
patch and applied on the back
of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (SH176-11): Product I |
The product is rinse off product.8% w/w solution of the
investigational product is
prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the
patch and applied on the back
of the volunteers at T0 visit .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.Female and male Asian Indian subjects.
2.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 checkup).
3.Between 18 and 65 years of age.
4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
5.Specific Criteria
-Subjects representing sensitive skin type (Subjects scoring greater than 30 for Section 2- Sensitive vs Resistant skin in Dr. Baumann’s questionnaire, please refer appendix 4) and varied skin type (ideally equal representation of all 4 skin types – Oily, Normal, Dry and Combination).
-Subjects who have not participated in a similar investigation in the past eight weeks.
|
|
| ExclusionCriteria |
| Details |
1.Standard criteria
-For female: Currently established to be pregnant or actively breast feeding or has recently stopped breast feeding < 3 months.
-Having refused to give his/her assent by signing the consent form.
- Currently participating in another study that is 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).
- Subjects with chronic illness that may influence the cutaneous state or any other illness including Diabetes, liver disease, HIV or any other serious medical illness.
-Subjects with cutaneous disease that could interfere with the study results.
-Having a diagnosed or highly probable allergy to one or several compounds of cosmetic products.
-Having undergone surgery requiring general anesthesia 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.
-Having applied some product on the back thus not meeting the study requirement.
-No individual sentenced to imprisonment by a court decision or by an administrative decision, or hospitalized without consent, or admitted in a medical or social establishment.
- No minor as well as individual of age benefiting from a legal protection measure or enable to express his/her consent
2.Refusing to follow the restrictions mentioned below during the study:
- For female: Avoid pregnancy or active breastfeeding.
- Abstain from participation 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, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
- Do not change cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit.
3.Specific criteria
- Having eczema, psoriasis, lichen planus, vitiligo etc. in the concerned area.
-Having healing disorder in the concerned area.
-Having rhinitis, allergic conjunctivitis, or rhino sinusitis.
-Having an allergy to perfumes and/or preservatives in cosmetic products.
-Having an allergy to plaster / adhesives used in plaster.
- Having a food allergy.
-Having a cardiovascular pathology that requires beta blocking treatments.
-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 neavi 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 (Evaluation of test sites by Dermat and Subject post 24 hrs. of 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 hrs,24 hrs & 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2023 |
| Date of Study Completion (India) |
29/06/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="8" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Single Application, Closed & Occlusive Patch Test is
conducted to measure the irritation potential of cosmetic products on the skin.
Objective: To
evaluate the dermatological safety of investigational products through primary
irritation patch test on healthy human volunteers with sensitive skin.
Duration of study: 8 days study Kinetics: T0 (Evaluation of
test sites by Dermat and Subject, Patch application), T on patch Application
Day, T+30mins post patch application, T1(Patch removal, Evaluation of test
sites by Dermat), T2(Evaluation of test sites by Dermat 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 35 healthy subjects(17 males + 18 females)
The distribution of volunteers as per skin type will be as
follows: Sensitive Combination skin : 4 Females + 4 Males Sensitive Dry skin –
4 Females + 4 Males Sensitive Oily skin – 5 Females + 5 Males Sensitive Normal
skin – 4/5 Females + 4/5 Males |