| CTRI Number |
CTRI/2024/08/072028 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of product on pimple spots |
|
Scientific Title of Study
|
To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of reduction in
hyperpigmentation, skin glow and skin radiance on healthy female subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-QF01-DD-JE24; Version: Final 01;04/07/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Yadav |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, AppaSaheb Marathe Marg,
Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
poojayadav@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Yadav |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, AppaSaheb Marathe Marg,
Century Bazaar, Prabhadevi, Mumbai, Maharashtra
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
poojayadav@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, AppaSaheb Marathe Marg,
Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Onesto Labs Pvt. Ltd.
Plot No. 309, Sector 6, IMT Manesar,
Gurugram, Haryana (122052) |
|
|
Primary Sponsor
|
| Name |
Onesto Labs Pvt. Ltd. |
| Address |
Plot No. 309, Sector 6, IMT Manesar,
Gurugram, Haryana (122052) |
| 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 Pooja Yadav |
Mascot Spincontrol India Pvt. Ltd. |
Sea Breeze Building, 9th Floor, AppaSaheb Marathe Marg,
Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
02243349191
poojayadav@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 |
| Patients |
(1) ICD-10 Condition: L819||Disorder of pigmentation, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
Vit C |
Product is applied on whole face once in a day for period of 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1. Indian female subjects.
2. Healthy subjects
3. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
4. Having hyperpigmentation (Acne PIH) dark spot
|
|
| ExclusionCriteria |
| Details |
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.
• Taking part in another study liable to interfere with this study.
• Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area.
• Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less
than 6 months).
• Having a progressive asthma (either under treatment or last fit in the last 2 years).
• Being epileptic.
• Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6
months).
• 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
• Having known allergy to any of the Ingredient of the Test Product.
• 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)
• Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6
months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in
hyperpigmentation (Acne PIH), improvement in skin glow & skin radiance |
Baseline, Day14, Day28 |
|
|
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)
|
16/08/2024 |
| 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="2"
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 :To evaluate the in-vivo efficacy and safety of a skin
care formulation in terms of reduction in hyperpigmentation (Acne PIH), skin
glow & skin radiance on healthy female subjects
The evaluation is performed using: Subject Self Evaluation, Dermatological
Evaluation: Safety, Dermatological Evaluation: Efficacy, Mexametry, CLBT
(Color, Luminosity, Brightness, Transparency), Illustrative Images of the whole
face & 3/4th face under diffuse light
The study last 28 days following first application of the test
product on the whole face.
POPULATION: 36 Female subjects will be selected for the study.
The subjects selected for this study are healthy females, aged
between 18 and 30 years, having
hyperpigmentation (Acne PIH) dark spot. |