| CTRI Number |
CTRI/2025/10/095750 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to Assess the Sun Protection Effect of a Body Lotion on Human Skin. |
|
Scientific Title of Study
|
An In Vivo Study to Determine the Sun Protection Factor (SPF) of Body Lotion. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B06155; Version: 01, Dated 25 Sep 25 |
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,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad-380054, Gujarat.
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Mori |
| Designation |
Medical Monitor |
| 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, Gujarat.
Ahmadabad
GUJARAT
380054
India |
| Phone |
9773262487 |
| Fax |
|
| Email |
damori@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parth Joshi |
| 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, Gujarat.
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, Beside 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
|
|
|
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 |
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.
Ahmadabad
GUJARAT |
8000085049
pjoshi@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 participants with ITA° value of at least greater than or equal to 28 degree using Chromameter and be untanned on the test area. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Body Lotion |
Fixed amount of test product will be applied to the skin, then spread over the whole test site using a finger cot. Single application |
| Comparator Agent |
Reference Standard |
Fixed amount of reference product will be applied to the skin, then spread over the whole test site using a finger cot. Single application |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Healthy adult males and non-pregnant/non-lactating females.
2) Participants with ITA° value of at least 28° using Chromameter and be untanned on the test area.
3) Participants with uniform skin color over the whole test area and with no variation in ITA° greater than 5° from each other or the MEDu test area.
4) Participants with test sites, free from pigmentation, nevi, sunburn and hair. |
|
| ExclusionCriteria |
| Details |
1) Participants with a history of abnormal responses to the sun (e.g., phototoxic or photoallergic responses).
2) Participants having marks, blemishes or nevi in the test area.
3) Participants presenting existing sun damage in the test area.
4) Participants who had sun exposure on their back within the eight weeks leading up to the SPF testing.
5) Participants having skeletal protrusions and extreme areas of curvature in the test area. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Individual Minimal Erythema Dose (iMED) Score |
Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Delayed Erythema Response |
Day 2 |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
27/10/2025 |
| 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="2" |
|
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
|
This is an in-vivo study designed to
determine the Sun Protection Factor (SPF) of a topical formulation through a
single assessment.
Potential participants will be
screened based on inclusion and exclusion criteria, following the provision of
written informed consent.
All eligible participants will
undergo clinical evaluation by a Dermatologist following exposure to a solar
simulator. Safety will be assessed throughout the study by monitoring adverse
events (AEs). |