| CTRI Number |
CTRI/2021/11/038345 [Registered on: 30/11/2021] Trial Registered Prospectively |
| Last Modified On: |
02/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [N/AP] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety & efficacy assessment of products on skin. |
|
Scientific Title of Study
|
To evaluate the safety and efficacy of skin care regime with combination of Bristaa Intense Cream and Photostable Gold Sunscreen Gel in female subjects with melasma and dark spots. |
| Trial Acronym |
N/AP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SP/Derm/BIPG/CS-PIV-01-2021; Version: 01; Dated: 08/11/2021 |
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 |
Kohinnor Estate, 3rd Floor,
Sun Mill compound,
Lower Parel,
Mumbai – 400013, INDIA
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| 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
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| 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 |
Kohinnor Estate, 3rd Floor,
Sun Mill compound,
Lower Parel,
Mumbai – 400013, INDIA
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
| The Study will be conducted at Mascot Spincontrol, Mumbai, India |
|
|
Primary Sponsor
|
| Name |
Sun Pharmaceutical Industries Limited |
| Address |
Sun House, 201 B/1,
Western Express Highway,
Goregaon (East), Mumbai,
Maharashtra (India) – 400 063
|
| 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. |
Kohinnor Estate, 3rd Floor,
Sun Mill compound,
Lower Parel,
Mumbai – 400013, INDIA
Mumbai (Suburban)
MAHARASHTRA |
022-43349191
raji@mascotspincontrol.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethos- An Institutional Ethics committee (Mumbai) |
Approved |
| Ethos- An Institutional Ethics committee (Mumbai) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Volunteers having Melasma or Dark spots |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ï® Bristaa Intense Cream : Product A
ï® Photostable Gold Sunscreen Gel : Product B
|
For Product A (Bristaa Intense Cream):
Approx. 1.0 gm quantity of given product will be applied on whole face in dot wise across and followed by smooth uniformly spreading of the product using only fingers in outward direction. The product will be applied twice a day morning & evening on whole face for the period of 90 days.
For Product B (Photostable Gold Sunscreen Gel):
Approx. 1.0 gm quantity of given product will be applied on whole face in dot wise across and followed by smooth uniformly spreading of the product using only fingers in outward direction. The product will be applied once a day in morning after application of product A on whole face for the period of 90 days
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Having Fitz Patrick Skin type III-IV
2 Having dark spots on face (with at least one dark spot ≥ 3.5mm in diameter) or having visible melasma on face (with mMASI score between 1-8)
3 Having dull skin (i.e., skin that lacks brightness & has uneven skin tone based on visual assessment by experts)
|
|
| ExclusionCriteria |
| Details |
1 Female who is pregnant or breastfeeding or has stopped breastfeeding in the past three months
2 Participating in another study liable to interfere with this study
3 Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
4 Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
5 Having progressive asthma
Being epileptic
Having non stabilized thyroid problems
Having cutaneous hypersensitivity
Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex
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) for more than 1 year.
Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
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)
Having started, changed or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy) in the past 3 months
For Smokers - Any change in smoking habits as below
- A person who was a non-smoker but has now started smoking >10 cigarettes per day in the last 6 months
- A person who was smoking <10 cigarettes per day but has started smoking >10 cigarettes per day in the last 6 months
- A person who was smoking >10 cigarettes per day but has now either stopped smoking or is smoking <10 cigarettes per day in the last 6 months
Having taken a medicinal treatment which could lead to hyper pigmentation (e.g. phenytoïn, amiodarone, metals, minocycline) in the previous 6 months
Taking oral supplements or topical application with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene)
Having applied beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask) or self-tanning products in the week preceding the start of the study
Having applied products with anti-wrinkle action (e.g. retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A.) in the 2 weeks preceding the start of the study
Having applied products with a depigmenting action (e.g. hydroquinone or derivates) in the 4 weeks preceding the start of the study
Having undergone physical and/or chemical treatments of the spots (e.g. liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel) in the previous 6 months
Having a suntanned skin on the studied areas which could interfere with the evaluations of the study
Have taken any other treatment that in the opinion of the investigator could interfere with the evaluations of the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety & Efficacy assessment of products |
Screening T0, T28 days , T42 days T56 days, T70 days and T90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
01/12/2021 |
| 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 Applicable |
| 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
|
Primary Objective:
To
assess the efficacy of skin care regime with combination of Bristaa Intense
Cream and Photostable Gold Sunscreen Gel in female subjects with melasma and
dark spots.
Secondary
Objective:
1.
To assess the safety of skin care regime with
combination of Bristaa Intense Cream and Photostable Gold Sunscreen Gel in
female subjects with melasma and dark spots
2.
To evaluate the cosmetic appeal of
a.
Photostable Gold
Sunscreen Gel
Combination of Bristaa Intense Cream and
Photostable Gold Sunscreen Gel |