| CTRI Number |
CTRI/2024/11/076303 [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) |
| Study Design |
Other |
|
Public Title of Study
|
A study to check the effectiveness of sunscreen |
|
Scientific Title of Study
|
A study to determine the UVA
Protection Factor of Test
products in adult subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/ITUV/2024-04 version 1.0 dated 07 Oct 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
principal investigator |
| 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
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
principal investigator |
| 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
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
principal investigator |
| 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
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 Bangalore
560058 Karnataka India. |
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences Technology Centre |
| Address |
Peenya Industrial Area I Phase Peenya Bangalore- 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 Pvt. Ltd |
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 subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Reference standard sunscreen for UVAPF S2 |
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 |
18.00 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 18 – 55 years (both the ages inclusive).
3. Subjects with a colorimetric ITA value in the range of 20-41o, providing
persistent pigmentation darkening to the UVA dose. (Phototype of the subject
will be recorded)
4. Subjects having a clear back with uniform colour and no sunburn (erythema),
tan, blemishes, cuts, wounds, injuries, allergies, or any skin condition on the
test areas (Upper back region between scapula and waist) that can hamper
the assessment.
5. 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.
6. Subject willing to avoid any exposure of the test area to artificial or natural
Ultraviolet (UV) light throughout the course of the study.
7. Subjects willing to adhere to the study procedure, restrictions and visit the
study site for follow up visits at the specified date and time.
8. Subjects with no known abnormal response to sunlight.
9. 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. Subjects who have participated in a similar investigation in the past 8 weeks.
12. 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 UVA protection factor of the investigational
product in adult subjects. |
Approximately for 06 days for each subject. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/11/2024 |
| Date of Study Completion (India) |
09/12/2024 |
| 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 test method is a laboratory method that utilizes a solar simulator of defined and known output
to determine the protection provided by the sunscreen product on human skin.
On screening visit (within a week from the assessment day), the subjects will be
enrolled into the study after obtaining their informed consent. Only subjects who qualify
inclusion-exclusion criteria will be enrolled. As part of screening procedure,
Spectrophotometer measurement will also be performed on the unexposed area and
subject’s upper back (Test Area) to determine ITA° value (Individual Typology Angle)
and their eligibility to participate in the study. After determination of MPPDDU, the participants will be scheduled for the sunscreen
test.
One of the randomized sites will be exposed to ultraviolet light (Total UV, calibrated
with UV-Bio radiometer) without any protection, and the other randomized test sites will
be exposed after the application of the test products and reference sunscreen
formulation respectively. The following day, MPPDDU (Minimal Persistent pigment
darkening dose - untreated site), MPPDDP (Minimal Persistent pigment darkening dose – study product site), MPPDDSTD (Minimal persistent pigment darkening dose –
Standard) will be recorded 20 + 4 hours following the UV exposure.
The
assessments must be performed at 20 + 4 hours post-exposure. The time between
exposure and assessment must be similar for all test sites.
These responses will be visually assessed* for the presence of persistent pigmentation
(UVAPF), 20 + 4 hours after UV irradiation, by the investigator. Observations of
protected (product) and unprotected test sites shall be conducted at the same relative
time point after the end of the exposures (i.e. if at 4 h, it is 4 h after completion of
exposures for the unprotected site and 4 h after completion of the protected site, not
actually at the same time). Observations shall all be made on the same day.
|