| CTRI Number |
CTRI/2022/09/045184 [Registered on: 02/09/2022] 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 reduction in acne, reduction in sebum, reduction in pore size and improvement in skin brightening on healthy male and female subjects.
Secondary objective: To evaluate the in-vivo efficacy of a skin care formulation in terms of improvement in skin even tone on healthy male and female subjects.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-ZF01-SQ-JY22; Version: Final 01; Dated: 17/08/2022 . |
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 |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) 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 |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 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 |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 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. 3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India |
|
|
Primary Sponsor
|
| Name |
SkinQ |
| Address |
Health Q Life Sciences Pvt Ltd, No. 204, 2nd Floor, Eva Mall, Brigade Road, Bengaluru – 560025 |
| Type of Sponsor |
Other [FMCG] |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not applicable |
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
having mild to moderate acne and oily to mixed oily skin type & visible pores |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acne Mask (EISACM-001) |
Product to be applied on whole face once in a day in morning and at night product to be applied on only ance for the period of 3 days |
| Comparator Agent |
Nil |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 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 30 years of age.
4 Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
5 Having mild to moderate acne and oily to mixed oily skin type & visible pores.
|
|
| ExclusionCriteria |
| Details |
1 For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2 Having refused to give his/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 acne prone skin.
6 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
7 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
8 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).
9 Having cutaneous hypersensitivity.
10 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
11 Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
12 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)
13 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 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. Do not use hair oil. The day of the measurements : No other cosmetic products must be used (only face cleaned with water is accepted). For Males: Shaving should be done before one day of T0 visit and 3 hrs before the night application on T+2 days
14 In the 6 previous months -Having started, changed or stopped a hormonal treatment (hormonal contraception, cyproterone acetate …) - Having taken an oral retinoid-based treatment -Having allergy to asprin / sulpha (salicylic acid).
15 In the previous month - Having undergone a physical (phototherapy, laser ..) or chemical (peeling) treatment for acne -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 (gluconate of zinc) or spironolactone
16 In the 2 previous weeks - Having applied cosmetic products with anti-seborrheic aims or cosmetics for oily skin - Having had oral or local antibiotic treatment for acne- 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
17 Refusing to follow the restrictions below during the study : - Do not apply cosmetic products with anti-seborrheic aims or cosmetics for oily skin - Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) - Do not start, change or stop a hormonal treatment (hormonal contraception, cyproterone acetate …) - Do not start a local or general treatment acting on seborrhoea - Do not expose herself to the sun. - Strictly avoid sun exposure
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
reduction in acne,
reduction in sebum, reduction in pore size and improvement in skin brightening |
baseline, 15 minute, 1 day, 3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in skin even tone |
baseline, 15 minute, 1 day, 3 days |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/09/2022 |
| Date of Study Completion (India) |
30/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="25" |
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
|
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Brief Summary
|
Objective:
PRIMARY OBJECTIVE To evaluate the in-vivo efficacy and safety of a skin
care formulation in terms of reduction in acne, reduction in sebum, reduction
in pore size and improvement in skin brightening on healthy male and female
subjects.
SECONDARY OBJECTIVE To evaluate the in-vivo efficacy of a skin care
formulation in terms of improvement in skin even tone on healthy male and
female subjects.
Duration of study: 3 days study
Kinetics: T0, T+15 minutes after product application, T+1 day and T+3
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. Sebumetry
6. Illustrative Diffuse Images of whole and ¾ th face by Visioface
|