| CTRI Number |
CTRI/2023/02/049645 [Registered on: 13/02/2023] Trial Registered Prospectively |
| Last Modified On: |
06/11/2023 |
| 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 Cosmetic Product on skin |
|
Scientific Title of Study
|
To evaluate the in-vivo safety and efficacy of the skin care formulation in terms of non-comedogenic effect on healthy human subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-2F01-JA-NR22; Version: Final 01; Dated: 13/01/2023 |
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, 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 |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Kohinoor Estate, 3rd Floor, Sun Mill compound, Lower Parel, Mumbai – 400013, INDIA
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, 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. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel – West, Mumbai – 400013,MAHARASHTRA, INDIA |
|
|
Primary Sponsor
|
| Name |
Ajanta Pharma Ltd |
| Address |
Unit No. 301/302, Satellite Gazebo,
B Wing, Andheri Ghatkopar Link Road,
Chakala, Andheri (E)
Mumbai – 400 013. India |
| 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. |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) 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 |
presenting oily or mixed oily skin on the face |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Humederm cream |
Product will be applied on the whole face, once in a day for a period of 28 days |
| Comparator Agent |
Nil |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1)Indian male and 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 35 years of age.
4)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
|
|
| ExclusionCriteria |
| Details |
1 Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2 Having refused to give her assent by not signing the consent form
3 Taking part in another study liable to interfere with this study
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 Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
8 Being epileptic.
9 Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
10 Having cutaneous hypersensitivity.
11 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
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 except those required by the protocol 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 Having applied hair oil during the entire duration of the study.
16 In the previous 6 months
-Having started, changed or stopped a hormonal treatment (e.g. hormonal contraception, cyproterone acetate)
-Having taken an oral retinoid-based treatment
-Having undergone a physical (e.g., phototherapy, laser) or chemical (peeling) treatment for acne
17 In the previous 1 month
-Having had a local benzoyl-peroxide-based treatment or a local retinoid-based treatment
-Having had an oral treatment with a base of cimetidine, zinc (zinc gluconate) or spironolactone
18 In the previous 2 weeks
-Having applied cosmetic products with anti-seborrheic aims or cosmetics for oily skin
-Having had oral or local antibiotic treatment for acne
19 In the previous 1 week
-Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask)
-Having a suntanned skin on the studied areas which could interfere with the evaluations of the study
20 Refusing to follow the restrictions below during the study:
- Do not start, change or stop a hormonal treatment (hormonal contraception, cyproterone acetate …)
- Do not apply cosmetic products with anti-seborrheic aims or cosmetics for oily skin or for skin with imperfections
- Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …)
- Do not start a local or general treatment acting on seborrhoea
- Do not expose to the sun with the intention to sunbathe (activities outside which do not last too much time are authorized)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percent reduction in total number of Comedones |
14days, 28days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/02/2023 |
| Date of Study Completion (India) |
16/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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:
The objective of this
study is to evaluate the in-vivo safety and efficacy of the skin care
formulation in terms of non-comedogenic effect on healthy human
subjects
Kinetics: T0, T+14 days
and T+28 days
Population: 36 Male and
Females volunteers
The evaluation is
performed using:
1 Subject
Self Evaluation (SSE) Questionnaire
2 Dermatological
Evaluation: Cosmetic Acceptability
3 Dermatologist
Evaluation: Efficacy
Duration: 28 days following the first
application of the product. |