Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai. Mumbai (Suburban) MAHARASHTRA 400013 India
Mumbai MAHARASHTRA
02243349191
raji@mascotspincontrol.in
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Suraksha-Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Having apparently healthy skin on Test area
Intervention / Comparator Agent
Type
Name
Details
Intervention
Ambhring Age Embrace
Revitalizer Hair Oil
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0, T2, T4, T7, T9, T11, T14, T16, T18 visits. There will be 10 repeated applications. At each time the occluded patch is removed after 24 hours i.e. on T1, T3, T5, T8, T10, T12, T15, T17, T19 visits.
Intervention
Keranya Pure Black Seed Potent Hair Potion
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0, T2, T4, T7, T9, T11, T14, T16, T18 visits. There will be 10 repeated applications. At each time the occluded patch is removed after 24 hours i.e. on T1, T3, T5, T8, T10, T12, T15, T17, T19 visits.
Intervention
Kesaradi Oil
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0, T2, T4, T7, T9, T11, T14, T16, T18 visits. There will be 10 repeated applications. At each time the occluded patch is removed after 24 hours i.e. on T1, T3, T5, T8, T10, T12, T15, T17, T19 visits.
Comparator Agent
Negative
Control
(0.9% Isotonic
saline solution)
40 microliters of 0.9% Isotonic
saline solution is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0, T2, T4, T7, T9, T11, T14, T16, T18 visits. There will be 10 repeated applications. At each time the occluded patch is removed after 24 hours i.e. on T1, T3, T5, T8, T10, T12, T15, T17, T19 visits.
Intervention
Paraania Oil
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0, T2, T4, T7, T9, T11, T14, T16, T18 visits. There will be 10 repeated applications. At each time the occluded patch is removed after 24 hours i.e. on T1, T3, T5, T8, T10, T12, T15, T17, T19 visits.
Intervention
Prinourish Skin- Enriching Superfood Serum
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0, T2, T4, T7, T9, T11, T14, T16, T18 visits. There will be 10 repeated applications. At each time the occluded patch is removed after 24 hours i.e. on T1, T3, T5, T8, T10, T12, T15, T17, T19 visits.
Intervention
Yauvari Amplified Youth-Spring
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0, T2, T4, T7, T9, T11, T14, T16, T18 visits. There will be 10 repeated applications. At each time the occluded patch is removed after 24 hours i.e. on T1, T3, T5, T8, T10, T12, T15, T17, T19 visits.
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. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
4. Photo type III to V.
5. Having apparently healthy skin on Test area.
6. For whom the Investigator considers that the compliance will be correct.
7. Cooperating informed of the need and duration of the examination and ready to comply with protocol procedures.
8. Having signed a consent form.
9. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
10. Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise sauna…) during the course of the study.
11. Should be able to read and write in English Hindi or local language.
12. Having valid proof of identity and age
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, antihistamines, 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 anaesthesia 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.
11. The day of the patch application: no cosmetic product must be used (test site clean with water only).
12. Scars excessive terminal hair or tattoo on the studied area.
13. Henna tattoo anywhere on the body (in case of studies involving hair dyes).
14. Dermatological infection pathology on the level of studied area.
15. Hypersensitivity & allergy to any cosmetic product raw material or hair dye.
16. Any clinical significant systematic or cutaneous disease which may interfere with the study treatment or procedure.
17. Chronic illness which may influence the outcome of this study.
18. Subjects on any medical treatment either systematic or topical which may interfere with the performance of the study treatment presently or in the past one month.
19. Subject in an exclusion. Or participating in another food cosmetic or therapeutic trial.
20. 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, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). - Do not change his/her cosmetic habit so yeah s apart from the particular conditions mentioned in the protocol, on the studied anatomic unit
Total Sample Size="230" Sample Size from India="230" 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)
24/06/2023
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="4" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
Nil
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
The objective of this study will be to evaluate the sensitization potential of Skin & Hair Care formulations on healthy human subjects
Product : Yauvari Amplified Youth-Spring, Prinourish Skin- Enriching Superfood Serum, Ambhring Age Embrace Revitalizer Hair Oil, Keranya Pure Black Seed Potent Hair Potion, Kesaradi Oil, Paraania Oil
The evaluation is performed using: Dermatological Evaluation: Human Repeat Insult Patch Test Method
Total duration of the study: 40 days following the first application of product.
The study is conducted in 3 phases: Induction Phase, Resting Phase, Challenge Plhase
Kinetics: Induction phase with 21 visits( T0, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, T12, T13, T14, T15, T16, T17, T18, T19 and T20) then resting phase of 14 days and 5 days of Challenge phase( T21, T22, T23, T24 & T25)
Induction phase is of 21 days and in which 9 repeated applications of patches are carried out which are removed after 24 hours of application and evaluated after 24 hours of patch removal. Resting phase is of 14 days in which no application of any patch is done in order to develop sensitization to the test product. In Challenge phase only one patch is applied which is removed after 24 hours and evaluated after 24 hours 48 hours and 72 hours
Number of volunteers: 230 subjects will be selected for the study. The subjects selected for this study will be healthy females and males, aged between 18 and 65 years old. In which 115 will be males and 115 will be females.