| CTRI Number |
CTRI/2023/02/049683 [Registered on: 13/02/2023] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety & efficacy assessment of products on skin. |
|
Scientific Title of Study
|
To evaluate & compare the in vivo safety & efficacy in terms of moisturizing effect of skin care formulations versus untreated control on healthy male and female subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-HD01-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 |
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 |
Principal 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. 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 |
Pharmaceutical industry-Indian |
|
|
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 |
having dry skin on the forearm |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aquasoft baby Cream (G1910): Product A |
Application is carried out once at site on the marked areas of 2.5 x 2.5 cm2 on the randomized inner forearms for the period of 24 hours |
| Intervention |
Humiderm Moisturizing Cream with Vitamin E (G1940): Product B |
Application is carried out once at site on the marked areas of 2.5 x 2.5 cm2 on the randomized inner forearms for the period of 24 hours |
| Comparator Agent |
Untreated site |
one site of 3x3 cm2 on the right inner forearm is served as untreated control site |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 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 65 years of age.
4. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
5. Having dry skin on forearms.
|
|
| 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 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, corticosteroid therapy, 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.
15. Refusing to follow the restrictions below during the study:
- For Females: 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, corticosteroid therapy, taken by general or local routes (the only medication permitted is paracetamol).
- Do not change 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 product to the studied areas.
16. Having started, changed, or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy, thyroid…) in the past 3 months.
17. Having taken an oral retinoid-based treatment in the past 6 months
18. Having taken a local retinoid-based treatment on the studied areas in the previous month
19. Having had beauty treatment (e.g. scrub, manicure, self-tanning product …) in the previous week
20. Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week.
21. Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
22. Having practiced intensive sports during the day prior to the T0 measurements
23. Having wounds, scars, sunburns, tattoos and piercing on test site.
24. Having hair on test site.
25. Having applied another product than water on the studied areas in the morning of the T0 measurements
26. Having had an intensive UV exposition on the inner forearm (solariums, sun) prior to T0 measurements.
27. Having used moisturizing products on the arms during 24 hours prior to T0 measurements.
28. 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 inner forearm.
- Do not wear jewels on the wrists.
- Do not have an intensive UV exposition on the arms (solariums, sun). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percent improvement in capacitance value i.e skin moisturization |
Baseline, 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours & 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| prevention of the water loss from skin |
Baseline, 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours & 24 hours |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
13/02/2023 |
| 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="0"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The objective of this
study will be to evaluate & compare the in vivo safety & efficacy in
terms of moisturizing effect of skin care formulations versus untreated control
on healthy female subjects.
The evaluation is performed using:
1. Subject Self Evaluation (SSE)
2. Dermatological Evaluation: Cosmetic Acceptability
3.
Corneometry
4.
Tewametry
Study Population :33 (16/17 male and 16/17 female) subjects
Study Duration
: 24 hours following the application of
the product |