| CTRI Number |
CTRI/2022/03/040715 [Registered on: 02/03/2022] Trial Registered Prospectively |
| Last Modified On: |
27/04/2023 |
| 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 a skin care formulation in terms of even skin tone, reduction in pigmentation (dark spot)& radiant skin on healthy male & female subjects.
SECONDARY OBJECTIVE To evaluate the in-vivo efficacy of a skin care formulation in terms signs of ageing: minimize fine lines, smooth skin texture, reducing dark circles and improvement in hydration on healthy male & female subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-NF08-KD-JR22; Version: Final 01; Dated: 15/02/2022 |
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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
MAHARASHTRA 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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
MAHARASHTRA 400013 India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai. MAHARASHTRA 400013 India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
| Mascot Spincontrol India Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Kama Ayurveda Pvt Ltd |
| Address |
3 K Commercial Circle, Jungpura Extension, New Delhi – 110014 |
| Type of Sponsor |
Other [Indian 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 |
Volunteers with dull skin, pigmentary spots, crow’s feet wrinkles, uneven skin, under eye dark circle, Fitzpatrick skin type III to V |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KMBF Face oil (KMBF – VR 01) : Product A |
Approximately 4-5 drops of the Product will be applied once in a day on whole face. for period of 28 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Having dull skin and uneven skin tone
2. Having pigmentary spot on the face of grade 2 to grade 6 according to the Bazins atlas
3. Having Crows feet wrinkle of grade 2 and above according to the Bazins atlas
4. Having visible under eye dark circle
5. Presenting Fitzpatrick skin type III to V with chromameter i.e. ITA° value between -30° &
41° on cheek bones.
|
|
| ExclusionCriteria |
| Details |
1. Having started, changed or interrupted one hormonal treatment during the past 3 months
2. Having started, changed or stopped her tobacco consumption in the previous 6 months
3. Having consumed caffeine-based products, alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
4. Having taken a medicinal treatment which could lead to hyper pigmentation in the previous 6 months
5. Taking oral supplements with major or minor effect on whitening of skin
6. 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
7. Having applied products with anti-wrinkle action in the 2 weeks preceding the start of the study
8. Having applied products with a depigmenting/ whitening action in the 4 weeks preceding the start of the study
9. Having undergone physical and/or chemical treatments of the spots in the previous 6 months
10. Having a suntanned skin on the studied areas which could interfere with the evaluations of the study For males, having not shaved their beard 24 hours prior to the day of measurement |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Even skin tone,
reduction in pigmentation (dark spot), radiant skin and skin brightness, safety of a skin |
Baseline, 14 days and 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Minimize fine
lines, smooth skin texture, reducing dark circles and improvement in skin hydration |
baseline, 14 days and 28 days |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/03/2022 |
| Date of Study Completion (India) |
18/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
Objective: PRIMARY OBJECTIVE To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of even skin tone,
reduction in pigmentation (dark spot), radiant skin and skin brightness on healthy male & female
subjects. SECONDARY OBJECTIVE To evaluate the in-vivo efficacy of a skin care formulation in terms signs of ageing: minimize fine
lines, smooth skin texture, reducing dark circles and improvement in skin hydration on healthy male
& female subjects Duration of study: 28 days study Kinetics: T0, T+14 days and T+28 days Population: 36 (18 Females & 18 Males) volunteers The evaluation is performed using: 1. Subject’s Self Evaluation, 2. Dermatological Evaluation: Cosmetic Acceptability, 3. Dermatological Evaluation: Efficacy 4. Chromametry 5. Corneometry 6. CLBT (Color, Luminosity, Brightness, Transparency) 7. Cutometry 8. Tewametry 9. Sebumetry 10. Mexametry 11. Illustrative photographs of whole face & ¾ th face under diffused light |