| CTRI Number |
CTRI/2023/02/049856 [Registered on: 20/02/2023] Trial Registered Prospectively |
| Last Modified On: |
22/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Ayurvedic Proprietary Medicine] |
| Study Design |
Other |
|
Public Title of Study
|
A study to check the sun protection benefits |
|
Scientific Title of Study
|
A randomized study to determine the Sun Protection Factor of Test product in healthy adult participants |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/HUSP/2022-50 Version 1.0 Dated 16 Dec 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
First floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
mukesh.ramnane@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritambhara |
| Designation |
Director- Business and Operation |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Room no.2, Ground floor,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
ritambhara@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudhanthiran S |
| Designation |
Study Manager |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
First Floor, Room no. 1, Councelling Area, 327/15, 1st main road, cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
sudhan@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Unilever Industries (P) Ltd Research Center Stores B.D Sawant Marg, Chakala Andheri (East) Mumbai – 400099, India |
|
|
Primary Sponsor
|
| Name |
Unilever Industries Pvt Ltd |
| Address |
Unilever Industries (P) Ltd Research Center Stores B.D Sawant Marg, Chakala Andheri (East) Mumbai – 400099, India |
| Type of Sponsor |
Other [FMCG(Fast moving Consumer Goods)] |
|
|
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 Mukesh Ramnane |
MS Clinical Research Pvt. Ltd. |
First floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor
Bangalore
KARNATAKA |
08041125934
08040917253
mukesh.ramnane@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Male and Female participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Day Cream – KB23 |
70mg of the test product will be applied using PDP pipette. One time application. |
| Comparator Agent |
Reference Standard
Sunscreen - P3
|
70mg of the test product will be applied using PDP pipette. One time application. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Participant able to read, understand and sign on informed consent form indicating willingness to participate in the study.
2. Participants of either male or female gender in age group 18 – 55 years (both the ages inclusive).
3. Test participants shall have an ITA° value of at least 28° by colorimetric methods and be untanned on the test area (i.e., back)
4. The average of the participants making up a test panel shall have an ITA° between 41° and 55°. [When possible, there should be participants with ITA°s in each of the three ITA° bands, 28° to 40°, 41° to 55°, and >56°. Where this is not possible, there shall be at least three individuals in each of two of the three ITA° bands described in the previous sentence].
5. The test sites intended for UV exposure shall be free from blemishes and hair, and have an even colour tone with no variation in ITA° greater than 5° from each other or the MEDu test area
6. Participants willing to discontinue the use of soaps and cosmetic products (e.g. creams, moisturizers) in the treatment areas throughout the course of the study.
7. Participant willing to avoid any exposure of the test area to artificial or natural Ultraviolet (UV) light throughout the course of the study.
8. Participants willing to adhere and comply to the study protocol, procedure, restrictions and vising the study site for follow up visits at the specified date and time.
9. Participants with no known abnormal response to sunlight.
10. Participants willing and capable to follow the study rules and a fixed schedule. |
|
| ExclusionCriteria |
| Details |
• Participants showing COVID symptoms (cold, cough, fever, fatigue, headache, diarrhea, difficulty in breathing)
• Participants who do not qualify on the thermal screening (body temperature higher than 37.5oC) or report to the study site without appropriate mask.
• If any household member is positive (self-reported by the participants) within the 10 days prior to screening or during the study, then the participant will be withdrawn from the study.
• Participants who disagree to follow the COVID safety protocol during the study.
• Participants who have travelled outside the state (current interstate travel regulation) in the last 10 days and do not have negative RT-PCR report issued in last 72 hours
1. Participants with sun tan, blemishes, photo-toxicity reactions, cuts, abrasions, wounds, injuries, allergic reactions (in the tested area).
2. Participants allergic to cosmetic products such as moisturizers, creams and body lotion or anything else.
3. Skin allergy antecedents or atopic participants.
4. Participants having history of or having active photo dermatitis.
5. Participants on any known medication for photosensitization. (e.g., oral diabetic medications, Sulphur drugs, cancer chemotherapy)
6. Participants with cutaneous disease which may influence the study result.
7. Participants on oral corticosteroid in last 2 months.
8. Participants participating in any other cosmetic or therapeutic study.
9. Participants who are pregnant or lactating
10. Participants with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
11. Participants who have participated in a similar investigation in the past 8 weeks.
12. Participants who are currently an employee of MSCR or Unilever |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the sun protection factor of the investigational product in reference to standard product in healthy adult participants. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
NA |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/02/2023 |
| Date of Study Completion (India) |
13/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single centre, double blinded, randomised and controlled study. The study will be conducted for a total of 4 visits for each participant at the study site. Once the subject is enrolled the test product will be applied on the back and then UV exposure will be performed. Post exposure , the assessment will be performed at 24 hrs. |