| CTRI Number |
CTRI/2024/03/064776 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
To study skin hydration after applying test product at 12 hours and 24 hours in humans. |
|
Scientific Title of Study
|
Evaluation of skin hydration, after application, of 1 test product (Venusia CeraPlus Lotion) on volar forearms, after 12 hours and 24 hours in men and /or women. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/170/0124/STU Version No.: 1 of 20 th February 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Clinical Aesthetics and Investigative Management Services Pvt. Ltd. |
| Address |
27 MIDC Commercial Premises, 5th Floor, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
rsjdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Preetha Paul |
| Designation |
Senior Manager - TQM |
| Affiliation |
Clinical Aesthetics and Investigative Management Services Pvt. Ltd |
| Address |
27 MIDC Commercial Premises, 5th Floor, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
preetha@claimsclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Preetha Paul |
| Designation |
Senior Manager - TQM |
| Affiliation |
Clinical Aesthetics and Investigative Management Services Pvt. Ltd |
| Address |
27 MIDC Commercial Premises, 5th Floor, 17th Road, MIDC, Andheri East
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
preetha@claimsclinical.com |
|
|
Source of Monetary or Material Support
|
| Dr. Reddy's Laboratories Ltd.,
7-1-27, Ameerpet
Hyderabad 500016, India |
|
|
Primary Sponsor
|
| Name |
Dr. Reddys Laboratories Ltd. |
| Address |
7-1-27, Ameerpet Hyderabad 500016, India |
| 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 Rajiv Joshi |
Clinical Aesthetics and Investigative Management Services Pvt. Ltd |
502, 5th Floor,27 MIDC Commercial Premises, 17 th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA |
66758851
rsjdrs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLAIMS Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human volunteers with dry skin will be included in the study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control site |
No product will be applied on control site for a duration of 24 hours. |
| Intervention |
Venusia CeraPlus Moisturizing Lotion |
Approximately 0.03 g of the product will be applied on test site, by massaging for 30 seconds. The Product will be left on the test site for a duration of 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Voluntary men and /or women between 18 and 55 years of age.
2. Dry skin type (MoistureMeter SC Readings less than 20).
3. Having signed a Consent Form after the study has been explained orally and in writing, of
all information concerning the study procedures and study objectives.
4. Presenting healthy skin on test sites.
5. Cooperating informed of the need and duration of the examinations. |
|
| ExclusionCriteria |
| Details |
1. Menopausal/Pregnant women by UPT, Lactating mothers.
2. Allergic to any cosmetic product.
3. A participant who the Investigator feels will not be compliant with study requirements.
4. Any type of skin disorder which Investigator feels will interfere with the study
5. Participants on any medical treatment either systemic or topical which may interfere with
the performance of the study treatment (presently or in the past 1 month). E.g. topical
steroids.
6. Chronic illness which may influence the skin sensitivity (skin problems like atopic
dermatitis, psoriasis, eczema or diseases like hypothyroidism, anaemia, hormonal
problems, or patients on anti-cholesterol drugs, etc)
7. Any cutaneous disease which would predispose to dry skin (confirmed by prior history).
8. Any cutaneous conditions on test site (scars, moles, papules etc).
9. Subject in an exclusion period or already participating in another similar cosmetic or
therapeutic trial as identified during screening on visit 1 (V1). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Hydration evaluation
2. Trans-epidermal water loss evaluation |
0 hour, 12 hour, 24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
Nil |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
19/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
Modification(s)
|
There will be 1 test product ‘Venusia CeraPlus Lotion, involved in the study. This is a cosmetic product. Moisturizers are widely used in various dermatologic and cosmetic skin therapies. Different classes of moisturizers are based on their mechanism of action, including occlusives, humectants, emollients, and protein rejuvenators. Commercially available moisturizers often utilize components of each of these classes to provide their beneficial effect. Scientifically, the moisturizing treatment involves a 4-step process:  Reducing TEWL  Repairing the skin barrier  Increasing water content  Restoring the lipid barriers’ ability to attract, hold and redistribute water. Occlusive agents increase moisture levels by providing a physical barrier to epidermal water loss. Ingredients with occlusive properties include petrolatum, waxes, oils, and silicones. Humectants work by attracting water from the dermis below and helping to keep that water bound in the stratum corneum. Humectants include ingredients like glycerin, urea, and pyrrolidone carboxylic acid (PCA). Emollients smooth skin by filling spaces between skin flakes with droplets of oil and are not usually occlusive unless applied heavily. When combined with an emulsifier, they may help hold oil and water in the stratum corneum. Examples of emollients include mineral oil, lanolin, fatty acids, cholesterol, squalene, and structural lipids . Results: The study was completed with 32 complete cases and no adverse events were reported during the study. |