| CTRI Number |
CTRI/2024/11/076308 [Registered on: 05/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [cosmetic study] |
| Study Design |
Other |
|
Public Title of Study
|
A study to check the effectiveness of sunscreen |
|
Scientific Title of Study
|
A study to determine the Sun
Protection Factor and Water Resistance
ability of Test Sunscreen products in
adult subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/ITSP/2024-03 ver 1.0,dated 14 Oct 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigators |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
MS Clinical Research Pvt. Ltd,
Department of Skin Sciences,
#324, Second Floor,
1st Main Road, Cambridge Layout,
Ulsoor, Bangalore - 560008, Karnataka,
India
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigators |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
MS Clinical Research Pvt. Ltd,
Department of Skin Sciences,
#324, Second Floor,
1st Main Road, Cambridge Layout,
Ulsoor, Bangalore - 560008, Karnataka,
India
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigators |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
MS Clinical Research Pvt. Ltd,
Department of Skin Sciences,
#324, Second Floor,
1st Main Road, Cambridge Layout,
Ulsoor, Bangalore - 560008, Karnataka,
India
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
|
Source of Monetary or Material Support
|
| ITC Life Sciences & Technology Centre
Peenya Industrial Area, I Phase, Peenya, Bengaluru-560058, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences & Technology Centre |
| Address |
Peenya Industrial Area, I Phase,
Peenya, Bengaluru-560058, Karnataka,
India |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Mukta Sachdev |
MS Clinical Research Pvt. Ltd |
Department of Skin Sciences,
#324, Second Floor,
1st Main Road, Cambridge Layout,
Ulsoor, Bangalore - 560008, Karnataka,
India
Bangalore
KARNATAKA |
08040917253
mukta.sachdev@msclinical.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy male and female |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Reference standard sunscreen for SPF P8 |
2.00 ± 0.05 mg/cm2 of the test product will be dispensed using a finger cot. Then spread over the whole test site, first with circular movements to gather the droplets and second in horizontal and vertical directions using light pressure. It will be applied once before the UV exposure. |
| Intervention |
sunscreen cream (PA++++) |
2.00 ± 0.05 mg/cm2 of the test product will be dispensed using a finger cot. Then spread over the whole test site, first with circular movements to gather the droplets and second in horizontal and vertical directions using light pressure. It will be applied once before the UV exposure. |
| Intervention |
sunscreen spray (PA++++) |
2.00 ± 0.05 mg/cm2 of the test product will be dispensed using a finger cot. Then spread over the whole test site, first with circular movements to gather the droplets and second in horizontal and vertical directions using light pressure. It will be applied once before the UV exposure. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject able to read, understand and sign on informed consent form indicating willingness to participate in the study.
2. Subjects of both genders in age group 19 – 55 years (both the ages inclusive).
3. Test subjects 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 subjects making up a test panel shall have an ITA between 41 and 55. [When possible, there should be subjects with ITAs in each of the three ITA bands, 28 to 40, 41 to 55, and more than 56. Where this is not possible, there shall be at least three individuals in at least 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. Subjects 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. Subjects willing to undergo water immersion testing, ensuring that the upper body or test sites remain submerged during a simulated swim test device.
8. Subject willing to avoid any exposure of the test area to artificial or natural Ultraviolet (UV) light throughout the course of the study.
9. Subjects willing to adhere to the study procedure, restrictions and visiting the study site for follow up visits at the specified date and time.
10. Subjects with no known abnormal response to sunlight.
11. Subjects willing and capable to follow the study rules and a fixed schedule.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with sun tan, blemishes, photo-toxicity reactions, cuts, abrasions,
wounds, injuries, allergic reactions (in the tested area).
2. Subjects allergic to cosmetic products such as moisturizers, creams and
body lotion or anything else.
3. Skin allergy antecedents or atopic subjects.
4. Subjects having history of or having active photo dermatitis.
5. Subjects on any known medication for photosensitization. (eg. oral diabetic
medications, Sulphur drugs, cancer chemotherapy)
6. Subjects with cutaneous disease which may influence the study result.
7. Subjects on oral corticosteroid in last 2 months.
8. Subjects participating in any other cosmetic or therapeutic study.
9. Subjects who are pregnant or lactating
10. Subjects with any history of underlying uncontrolled medical illness including
diabetes, liver disease or history of alcoholism, HIV or any other serious
medical illness.
11. People suffering from CVD or hypertension or hypotension or are prone to
develop hypothermia and subjects suffering from arthritis (all conditions are
self-declared).
12. Subjects who have participated in a similar investigation in the past 8 weeks.
13. Subjects who are currently an employee of MSCR or the sponsor |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the sun protection factor and water resistance of test sunscreen products in adult subjects. |
Approximately 6 days for each subject |
|
|
Secondary Outcome
|
|
|
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)
|
08/11/2024 |
| Date of Study Completion (India) |
06/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="6" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
The study employs a solar simulator to assess the protective efficacy of sunscreen on human skin. Participants undergo screening to determine eligibility, including ITA° value measurement. A provisional MEDu is established to set UV exposure ranges for untreated and treated sites. During the sunscreen test, one site is exposed to UV without protection, while others receive test and reference products. Erythema is evaluated 20±4 hours post-exposure. Water resistance is assessed through controlled immersion cycles, followed by air drying, before additional UV exposure to measure SPFiwr, adhering to ISO guidelines. |