| CTRI Number |
CTRI/2022/09/045260 [Registered on: 06/09/2022] Trial Registered Prospectively |
| Last Modified On: |
02/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and efficacy assessment of Product on skin |
|
Scientific Title of Study
|
Primary Objective: To evaluate the in-vivo efficacy and safety of Skin care formulation in terms of tan reduction, reduction in pigmentation and skin smoothness on healthy male and female subjects.
Secondary Objective: To evaluate the in-vivo efficacy and safety of Skin care formulation in terms of Skin brightness and Skin even tone on healthy male and female subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-NF01-SQ-JY22; Version: Final 01; Dated: 26/08/2022 . |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
MASCOT-SPINCONTROL India Pvt. Ltd.,
Kohinnor Estate, 3rd Floor, Sun Mill compound, Lower Parel,
Mumbai – 400013, INDIA
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Kohinnor Estate, 3rd Floor, Sun Mill compound, Lower Parel,
Mumbai – 400013, INDIA
Mumbai
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 |
Kohinnor Estate, 3rd Floor, Sun Mill compound, Lower Parel,
Mumbai – 400013, INDIA
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 (Suburban) MAHARASHTRA 400013 India |
|
|
Primary Sponsor
|
| Name |
SkinQ |
| Address |
Health Q Life Sciences Pvt Ltd, No. 204, 2nd Floor, Eva Mall, Brigade Road, Bengaluru – 560025 |
| 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. |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai. MAHARASHTRA 400013 India
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 |
Healthy subjects having tanned minimal forehead and uneven skin tone with pigmentation (Acne PIH and or Melasma) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Not Applicable |
| Intervention |
Sunscreen SPF 40 (SP6-003) |
Product to be applied on whole face and neck, twice in a day for the period of 28 days. In morning (before sun exposure) and noon (around 1 PM)}. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Indian male & female subjects.
2. Healthy 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 45 years of age.
4. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
5. Having tanned minimal forehead.
6. Having uneven skin tone with pigmentation (Acne PIH / Melasma)
|
|
| ExclusionCriteria |
| Details |
1. For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2. For Male: Shave beard 1day prior before visit
3. Having refused to give his/her assent by not signing the consent form
4. Taking part in another study liable to interfere with this study
5. Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
6. Having acne prone skin.
7. Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
8. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
9. 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).
10. Having cutaneous hypersensitivity.
11. Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
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 in the 14 days preceding the start of the study on the studied anatomic unit.
14. Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted)
15. Refusing to follow the restrictions below during the study: For Females: Do not take part in any family planning activities leading to pregnancy and breastfeeding. 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, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). Do not change their cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit During the study: Do not use other cosmetic products than the tested products to the studied areas. The day of the measurements: No test product must be used (only face cleaned with water is accepted)
16. Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months.
17. Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months.
18. Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
19. Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months
20. Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta carotene…)
21. Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) or having applied self-tanning products in the week preceding the start of the study
22. Having applied products with a depigmenting/ whitening action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
23. Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel …) in the previous 6 months
24. Having a suntanned skin on the studied areas which could interfere with the evaluations of the study.
25. Refusing to follow the restrictions below during the study: - Do not start, change or stop a hormonal treatment (hormonal contraception, Hormone Replacement Therapy) - Do not start a medicinal treatment which could lead to hyper pigmentation. - Do not take oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…) - Do not consume caffeine-based products (coffee, cola, tea), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements. - Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) or apply self tanning products. - Do not use products or techniques or surgery with a depigmenting / whitening action. - Do not expose herself to the sun by respecting a strict photo-protection.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tan reduction,
reduction in pigmentation and skin smoothness |
Baseline, Day14, Day28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Skin brightness and
Skin even tone |
Baseline, Day14, Day28 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
12/09/2022 |
| 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="3"
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
|
Objective:
Primary Objective: To evaluate the in-vivo efficacy
and safety of Skin care formulation in terms of tan reduction, reduction in
pigmentation and skin smoothness on healthy male and female subject.
Secondary Objective: To evaluate the in-vivo efficacy
and safety of Skin care formulation in terms of Skin brightness and Skin even
tone on healthy male and female subject.
Duration of study: 28 days study
Kinetics: T0, T+14 days and T+28 days
Population: 36 (Male & Female) volunteers
The evaluation is performed using:
1 Subject’s
Self Evaluation,
2 Dermatological
Evaluation: Cosmetic Acceptability,
3 Dermatological
Evaluation: Efficacy
4 Chromametry
5 Mexametry
6 Illustrative
Images of the whole face under diffuse light
|