| CTRI Number |
CTRI/2025/01/079167 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Other |
|
Public Title of Study
|
Study to check the safety and effectiveness of products on human volunteers |
|
Scientific Title of Study
|
To evaluate and compare the in-vivo safety and efficacy of Skin Care Formulation verses Untreated Control in terms of skin moisturization and skin barrier function on healthy female subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-HD04-AP-OR24 Version: 01 Dated: 23/10/2024 |
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 400025, INDIA
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 400025, INDIA
Mumbai
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 400025, INDIA
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alembic Pharmaceuticals Ltd. 3rd floor, Prime Corporate Park, Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri (E), Mumbai – 99 |
|
|
Primary Sponsor
|
| Name |
Alembic Pharmaceuticals Ltd. |
| Address |
3rd floor, Prime Corporate Park, Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri (E), Mumbai – 99 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 400025, INDIA
Mumbai
MAHARASHTRA
400025
India
Mumbai
MAHARASHTRA |
02243349191
poojayadav@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 dry skin type |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oryza Acne Cream |
The Product is applied on marked site of 3 x 3 cm2 on inner forearm once at site and left at is for 72 hours. Application is done only one time and site will be kept as it is for 72 hours. |
| Comparator Agent |
Untreated control site on inner forearm. |
A site of 3 x 3 cm2 marked on inner forearm is kept as untreated control site. No product application is done on untreated control site for test period of 72 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Indian female subjects
2.Healthy subjects
3.Skin is healthy on the studied anatomic unit
4.Subject having dry skin on forearms. |
|
| 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 not signing the consent form and Informed consent form
3. Taking part in another study liable to interfere with this study
4. Being known diabetic case
5. Known asthma case
6. Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
7. Being known thyroid case
8. Being epileptic.
9. 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 or corticosteroid by any route (the only medication permitted is paracetamol)
10. Known case of 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 their 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 48 hours prior study.
Refusing to follow the restrictions below during the study:
1. Do not take part in any family planning activities leading to pregnancy and breastfeeding.
2. Do not take part in another study liable to interfere with this study.
3. 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)
4. Do not change her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit
5. During the study: Do not use other cosmetic products than the tested products to the studied areas.
Specific criteria
1. Having started, changed, or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy, thyroid…) in the past 3 months.
2. Having taken an oral retinoid-based treatment in the past 6 months
3. Having taken a local retinoid-based treatment on the studied areas in the previous month
4. Having had beauty treatment (e.g. scrub, manicure, self-tanning product …) in the previous week
5. Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week.
6. Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week
7. Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
8. Having practiced intensive sports during the day prior to the T0 measurements
9. Having wounds, Scars, sunburns, tattoos and piercing on test site.
10. Having hair on test site.
11. Having applied another product than water on the studied areas in the morning of the T0 measurements
12. Having had an intensive UV exposition on the inner forearm (solariums, sun) prior to T0 measurements.
13. Having used moisturizing products on the arms during 24 hours prior to T0 measurements.
Refusing to follow the restrictions below during the study:
• Do not have beauty treatment (e.g. scrub, manicure self-tanning product …)
• Do not practice water activities (swimming pool, sauna, hammam, balneotherapy etc.)
• Do not drink/ eat caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food, nor smoke - Do not practice sport
• Do not apply any product on inner forearm including water.
• Do not wipe their forearm.
• Do not wear jewels on the wrists.
• Do not have an intensive UV exposition on the arms (solariums, sun).
Between T0 and T+72 hours measurements:
• Do not use skin care products on the inner forearms. -
• Do not wash the inner forearms.
• Do not use Surfactant containing product on the test sites.
• Daily morning hygiene with water accepted except on inner forearms.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| skin moisturization and skin barrier function |
T0, 30 Minutes, 24 hours, 48 hours & 72 Hours after product application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2025 |
| Date of Study Completion (India) |
30/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 will be to evaluate and compare the in-vivo safety and efficacy of Skin Care Formulation verses Untreated Control in terms of skin moisturization and skin barrier function on healthy female subjects for product.
Test Product: Oryza Acne Cream: Product A Techniques: The evaluation is performed using: 1) Subject Self Evaluation, 2) Dermatological Evaluation: Safety, 3) Corneometry and 4) Tewametry
Total duration of the study: 72 hours following the first application of the product.
Kinetics: T0, T+30 Minutes, T+24 hours, T+48 hours & T+72 Hours after product application
POPULATION: 33 female subjects will be selected for the study.
The subjects selected for this study are healthy female subject, aged between 18 and 40 years old, having dry skin on forearms |