| CTRI Number |
CTRI/2023/06/054039 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
13/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceutical] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety & Efficacy assessment of skin care regime |
|
Scientific Title of Study
|
To evaluate the in-vivo efficacy & safety of a skin care regime in terms of improvement in the
Moisturisation, & skin smoothness on healthy female subjects having varied skin type. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-HF05-DT-MY23; Version: Final 01; Dated: 24/05/2023 |
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 |
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 |
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
Public Query
|
| Name |
Dr 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 |
| 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 MAHARASHTRA 400013 India |
|
|
Primary Sponsor
|
| Name |
DPKA UNIVERSAL CONSUMER VENTURES PRIVATE LIMITED |
| Address |
3002, 30th Floor, Beau Monde, Tower B, Prabhadevi Road, Prabhadevi, Mumbai - 400025 |
| 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. |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, 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 |
Having all skin type(oily skin, normal skin, sensitive skin (declared through lactic acid sting test)). |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gel Moisturizer: Product A |
Approximately 0.5 - 0.7 gm. of the test product A on a fingertip. Applying dot wise on the whole face using only fingers in an outward direction. The test product is to be used twice a day in the morning and evening on the whole face for a period of 28 days. |
| Comparator Agent |
NIL |
NIL |
| Intervention |
STD FACEWASH: Product B |
The whole face is to be washed with the test product B. The face is to be washed twice a day for a period of 28 days. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Indian / Asian 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 21 and 50 years of age
4. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 5.Specific criteria
5.1 Having all skin type.
5.2 32 oily skin +12 normal skin + 12 subjects with sensitive skin (declared through lactic acid sting test)
|
|
| ExclusionCriteria |
| Details |
1.Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
2.Having refused to give his/her assent by signing the consent form.
3.Taking part in another study liable to interfere with this study.
4.Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
5.Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
6.Having a progressive asthma (either under treatment or last fit in the last 2 years)
7.Being epileptic
8.Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
9.Having cutaneous hypersensitivity
10.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex
11.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)
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:
-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 his/her 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 (Standard facewash provided by sponsor should only be used)
-The day of the measurements: No test product must be used (only face cleaned with water is accepted).
16. Specific criteria –
-Having started, changed, or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy) in the past 3 months.
-Having started, changed, or stopped his/her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
-Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months
-Taking oral supplements with major or minor effect on whitening of skin (e.g., vitamin C, beta carotene…)
-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
-Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study
-Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
-Having applied products with a depigmenting action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
-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
-Having a suntanned skin on the studied areas which could interfere with the evaluations of the study
17. 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 start an oral or local retinoid-based treatment
- 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 action.
- Do not practice water activities (swimming pool, sauna, hammam, balneotherapy).
- Do not practice sport the days of study. - Do not expose yourself 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 |
Efficacy & safety of a skin care regime in terms of improvement in the
Moisturisation, & skin smoothness |
Baseline, 30 minutes,4 Hours,6 Hours,7 days,14 days & 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Efficacy & safety of a skin care Regime in terms of improvement in Skin
Brightness & Sebum reduction |
Baseline, 30 minutes,4 Hours,6 Hours,7 days,14 days & 28 days |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
22/06/2023 |
| 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="1"
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
|
OBJECTIVE
PRIMARY OBJECTIVE: The objective of this study
will be to evaluate the in-vivo efficacy and safety
of a skin care regime in terms of improvement in the Moisturisation, and skin
smoothness on healthy female subjects having varied skin type.
SECONDARY
OBJECTIVE : The
objective of this study will be to
evaluate the efficacy and safety of a skin care Regime in terms of Improvement
in Skin Brightness, Sebum reduction on healthy female subjects having varied
skin type.
coded:
Gel Moisturizer: Product A
STD FACEWASH: Product B
The evaluation is performed using:
-Subject
Self Evaluation
-Dermatological
Evaluation: safety
-Dermatological
Evaluation: Efficacy
-Chromametry
-Corneometry
-Sebumetry
-Illustrative
Images of the whole face
The study lasts 28 days following the first application
of the product on the whole face.
POPULATION
56 female subjects are selected for the study.
The subjects selected for this study are healthy female
subjects, aged between 21 to 50 years, having
32 subjects with oily skin + 12 subjects with normal skin + 12 subjects with
sensitive skin (declared through lactic acid sting test)].
Kinetics
T0, T+30 minutes after product application, T+4 Hours,
T+6 Hours T+7 days, T+14 days & T+28 days |