| CTRI Number |
CTRI/2022/04/042030 [Registered on: 21/04/2022] Trial Registered Prospectively |
| Last Modified On: |
31/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceutical - Moisturization Study] |
| Study Design |
Other |
|
Public Title of Study
|
To Evaluate the Moisturization Properties of Test Products in Healthy Adult Human Subjects. |
|
Scientific Title of Study
|
A Single Center, Application Site Randomized, Evaluator-Blinded, Moisturization Study to Evaluate the Moisturization Properties of Test Products in Healthy Adult Human Subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B01947; Version 01, 22 Mar 22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
917966219549 |
| Email |
pjoshi@ofacto.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
917966219549 |
| Email |
pjoshi@ofacto.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director - Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
917966219549 |
| Email |
ssethi@ofacto.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research,
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India |
|
|
Primary Sponsor
|
| Name |
Duosis BioInnovations Pvt Ltd |
| Address |
Incubatee suit No: 9
NPIC-CIF
CSIR-CFTRI
Mysore 570020 |
| Type of Sponsor |
Other [Health and Hygiene] |
|
|
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 Parth Joshi |
Cliantha Research |
Garden View Corporate House No. 7, Consumer Research Department, Room No. 01
Opp. Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT |
8000085049
917966219549
pjoshi@ofacto.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male and Female subjects of age of 18 to 65 years old (both are inclusive at the time of consent) will be enrolled in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cliantha Code A: Skin care Product (01) |
Single Application, Approx. 50mg of test products will be applied on subject’s volar forearms, on 3 x 3 cm square test site, as per randomization schedule, 24 hr |
| Intervention |
Cliantha Code B: Skin care Product (02) |
Single Application, Approx. 50mg of test products will be applied on subject’s volar forearms, on 3 x 3 cm square test site, as per randomization schedule, 24 hr |
| Intervention |
Cliantha Code C: Skin care Product (03) |
Single Application, Approx. 50mg of test products will be applied on subject’s volar forearms, on 3 x 3 cm square test site, as per randomization schedule, 24 hr |
| Intervention |
Cliantha Code D: Skin care Product (04) |
Single Application, Approx. 50mg of test products will be applied on subject’s volar forearms, on 3 x 3 cm square test site, as per randomization schedule, 24 hr |
| Comparator Agent |
Control Site |
No Product Application |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject between ages of 18 to 65 (both inclusive) years old at the time of consent.
2. Gender: Males and non-pregnant, non-lactating females.
3. Female subjects of childbearing potential must have a negative urine pregnancy test performed on Screening visit and Enrolment.
4. Subject general in good health as determined from a recent medical history.
5. Subject is willing to participate in the study, give a voluntary written informed consent.
6. Subjects willing to abide by and comply with the study protocol.
7. Subjects should not participate in any other clinical study during participation in the current study. |
|
| ExclusionCriteria |
| Details |
1. Use of Body milk /lotion / cream, cosmetics or any other body moisturizing product before 3-5 days prior to study and during the study period.
2. Chronic illness which may influence the cutaneous state.
3. Subjects on any systemic medication.
4. Subject with history of diabetes.
5. Subjects participating in a similar clinical study, currently or during the previous 30 days.
6. Any subjects, in the Investigator opinion not considered suitable for enrollment.
7. A known history or present condition of allergic response to any other concern that may require medical attention.
8. Subjects with medical history (past/present) of significant dermatological diseases or conditions, such as atopy, psoriasis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g., porphyria) chronic urticaria, or sunburn, rashes.
9. Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g., tattoos, scars, and sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. volar forearm that can interfere with the reading. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Skin moisture i.e., hydration state of the skin by Corneometer CM 825 or MoistureMeterSC |
Baseline i.e., Day 1 before application, T1 hour (plus 15mins), T4 hours (plus 15mins), T8 hours (plus 15mins) after application on Day 1 and T24 hours (plus 15mins) after application on Day 2. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Skin physical parameter by Dermatologist | Dermatologist Validated Scorer using 5-point scoring scale for skin dryness, skin roughness, skin redness/erythema, burning, itching and stinging and 8-point scoring scale for skin suppleness and softness |
Baseline i.e., Day 1 before application, T1 hour (plus 15mins), T4 hours (plus 15mins), T8 hours (plus 15mins) after application on Day 1 and T24 hours (plus 15mins) after application on Day 2. |
| Product response index (perception about product) |
T24 hours (plus 15mins) after application on Day 2 |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
30/04/2022 |
| 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="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
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 aim of this observational study is determined the effect of moisturizers properties of various skin
care products on all skin types in healthy adults’ subjects. The proposed
benefits are evaluated by the dermatologist/dermatologist trained evaluator and
assessment questionnaire at 24 hours after test product application. The
instrumental evaluation of skin hydration will be done at before
application to 1 hour (+15mins), 4 hours (+15mins), 8 hours (+15mins), and 24
hours (+15mins) after application of 4 skin care
products. |