| CTRI Number |
CTRI/2023/12/060574 [Registered on: 20/12/2023] Trial Registered Prospectively |
| Last Modified On: |
18/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [skin care formulation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy check of skin care product |
|
Scientific Title of Study
|
To evaluate the in-vivo safety and efficacy of the skin care formulation in terms of reduction in acne reduction in pore size, reduction in skin sebum content & improvement in skin brightness on healthy human subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-ZF01-UL-NR23; Version: Final 01; 22/11/2023 |
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.
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 |
| 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.
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| SATIYA NUTRACEUTICALS PRIVATE LIMITED Building No B3 2G, ASMEETA TEXTILE PARK MID, IND KALYAN [1] BHIWANDI RD KON, Bhiwandi, Thane, Maharashtra, 421311 |
|
|
Primary Sponsor
|
| Name |
SATIYA NUTRACEUTICALS PRIVATE LIMITED |
| Address |
SATIYA NUTRACEUTICALS PRIVATE LIMITED Building No B3 2G, ASMEETA TEXTILE PARK MID, IND KALYAN [1] BHIWANDI RD KON, Bhiwandi, Thane, Maharashtra, 421311 |
| 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, Mumbai.
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 mild to moderate acne and oily to mixed oily skin type and visible pores |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jamun Active Acne Control |
Approx. 0.5-1 gms quantity of product to be used to wash the face. Product to be applied twice in a day for period of 14 days. |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1)Skin is healthy on the studied anatomic unit
2)Having mild to moderate acne
3)Having mixed oily or oily skin on the face.
4)Having visible pores |
|
| ExclusionCriteria |
| Details |
1)For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.Having refused to give her assent by signing the consent form.
2)Taking part 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 a progressive asthma (either under treatment or last fit in the last 2 years)
6)Being epileptic
7)Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
8)Having cutaneous hypersensitivity
9)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex
10) 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)
11)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
12)Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
13)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).
14)Having applied hair oil during the entire duration of the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in acne reduction in pore size, reduction in skin sebum content & improvement in skin brightness |
Baseline, Day 3, Day 7, Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
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)
|
27/12/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
OBJECTIVE - The objective of this study is to evaluate the in-vivo safety and efficacy of the skin care formulation in terms of reduction in acne reduction in pore size, reduction in skin sebum content & improvement in skin brightness on healthy human subjects POPULATION - 36 (18 males + 18 females) subjects are selected for the study. The subjects selected for this study are healthy males & females, aged between 18 and 30 years, having mild to moderate acne and oily to mixed oily skin type and visible pores. DURATION - 14 days following the first application of the product STUDY DESIGN - Single blind study. The evaluation is performed using- 1) Subject’s Self Evaluation, 2)Dermatological Evaluation: Safety 3)Dermatological Evaluation: Efficacy 4) Sebumetry 5)Illustrative photographs of whole face & ¾ th face under diffused light |