| CTRI Number |
CTRI/2025/07/090037 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate the Moisturization Properties of Test Products. |
|
Scientific Title of Study
|
A Single Center, Application Site Randomized, Blinded, Moisturization Study to Evaluate the Moisturization Properties of Test Products in Healthy Adult Human Participants. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B05668; Version: 01, Dated 17 Jun 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhagirath Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev,
Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825618138 |
| Fax |
|
| Email |
bpatel3@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simran Sethi |
| Designation |
Senior Director-Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev,
Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parth Joshi |
| Designation |
Sub - Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev,
Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054, Gujarat, India. |
| Zydus Wellness Products Limited, Plot No 115/5 TP Scheme No 51, Besides Bliss Apartment, Opp Viola Apartment, Ambli Bopal Road, Ahmedabad 380015. |
|
|
Primary Sponsor
|
| Name |
Zydus Wellness Products Limited, |
| Address |
Plot No 115/5 TP Scheme No 51, Beside Bliss Apartment, Opp Viola Apartment, Ambli Bopal Road, Ahmedabad 380015. |
| Type of Sponsor |
Other [Health and Hygiene] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
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 Bhagirath Patel |
Cliantha Research |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off Sindhubhavan Road,
Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad-380054, Gujarat.
Phone# +91-79-66135601
Ahmadabad
GUJARAT |
9825618138
bpatel3@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy males and non-pregnant/non-lactating females (Preferably equal ratio) between age group of 18 to 50 years (both inclusive at the time of consent) will be included in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Site |
No product application |
| Intervention |
Everyuth Naturals Body Lotion Nourishing Cocoa (New) |
Approx. 50 mg, Neat, Single application on volar forearms |
| Intervention |
Everyuth Naturals Body Lotion Rejuvenating Flora (New) |
Approx. 50 mg, Neat, Single application on volar forearms |
| Intervention |
Everyuth Naturals Body Lotion Soothing Citrus Aloe (New) |
Approx. 50 mg, Neat, Single application on volar forearms |
| Intervention |
Everyuth Naturals Body Lotion Suncare Berries SPF 15 (New) |
Approx. 50 mg, Neat, Single application on volar forearms |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy males and non-pregnant/non-lactating females (Preferably equal ratio) with age 18 to 50 years (both inclusive at the time of consent).
2. Participants having good general health as determined by the Investigator on the basis of medical history.
3. Female participants of childbearing potential must have a negative urine pregnancy test performed at enrollment visit.
4. Participants willing to abstain from using any cosmetic product on test sites, during the course of the study.
|
|
| ExclusionCriteria |
| Details |
1. Participants using Body milk /lotion / cream, cosmetics or any other body moisturizing product 3-5 days prior to study.
2. Participants who are on systemic medication or any medications would compromise the study.
3. Chronic illness which may influence the cutaneous state.
4. Participant 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.
5. Participants with known allergy or sensitivity to cosmetic products and/or any ingredients of the test product.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Instrumental and Dermatological Assessment |
Day 01 [(Before application (i.e., baseline)] and after application at 30 mins(+05 mins) and 06 hours (+15 mins)] and 12 hours (+15 mins) on Day 01, on Day 02 [24 hours (+15 mins) and 36 hours (+15 mins) after application] and on Day 03 [48 hours (+15 mins) after application] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subjective Evaluation |
Day 01 [30 mins(Plus 05 mins) after application] and Day 03 [48 hours (Plus 15 mins) after application] |
|
|
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)
|
20/07/2025 |
| 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="3" |
|
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
|
A single center, blinded, application
site-randomized, four-arm, moisture kinetics study.
The potential participants will be screened as per the inclusion and
exclusion criteria only after obtaining written informed consent from the
participants.
All eligible participants will undergo clinical evaluation by a
Dermatologist, instrument evaluation and subjective evaluation. Safety will be
assessed throughout the study by monitoring adverse events. |