| CTRI Number |
CTRI/2025/02/080873 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Silicone Sunscreen Gel for UV Protection to check Effectiveness and Tolerability. |
|
Scientific Title of Study
|
Effectiveness and Tolerability of Silicone Sunscreen Gel in Individuals for protection against ultraviolet radiation (UVA/UVB): An Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Sunscreen-03 11/2024;Version 01 (15th Nov. 2024) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjyot Gautam |
| Designation |
Principle investigator |
| Affiliation |
D. Y. Patil Deemed to be University, School of Medicine, Navi Mumbai |
| Address |
Department of Dermatology,1st floor,OPD NO.54, Dr. D.Y. Patil University School of Medicine
D Y Patil Hospital, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9870127812 |
| Fax |
|
| Email |
manjyotgautam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjyot Gautam |
| Designation |
Principle investigator |
| Affiliation |
D. Y. Patil Deemed to be University, School of Medicine, Navi Mumbai |
| Address |
Department of Dermatology,1st floor,OPD NO.54, Dr. D.Y. Patil University School of Medicine
D Y Patil Hospital, Nerul, Navi Mumbai
MAHARASHTRA
400706
India |
| Phone |
9870127812 |
| Fax |
|
| Email |
manjyotgautam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjyot Gautam |
| Designation |
Principle investigator |
| Affiliation |
D. Y. Patil Deemed to be University, School of Medicine, Navi Mumbai |
| Address |
Department of Dermatology,1st floor,OPD NO.54, Dr. D.Y. Patil University School of Medicine
D Y Patil Hospital, Nerul, Navi Mumbai
MAHARASHTRA
400706
India |
| Phone |
9870127812 |
| Fax |
|
| Email |
manjyotgautam@gmail.com |
|
|
Source of Monetary or Material Support
|
| D9 Healthcare LLP
even Heaven Bungalows Row House No. 4,Kaul Heritage City Bhabola Chulna Road Vasai West. Dist. Palghar,Maharashtra, 401202 |
|
|
Primary Sponsor
|
| Name |
D9 Healthcare LLP |
| Address |
Seven Heaven Bungalows Row House No. 4,Kaul Heritage City Bhabola Chulna Road Vasai West. Dist. Palghar,Maharashtra, 401202
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| DrManjyot Gautam |
Dr.D. Y. Patil Hospital,Nerul |
D Y Patil Medical College Hospital and
Research Centre, first floor,OPD no 54, D Y Patil University School of Medicine Sector 5 Nerul Navi Mumbai
Thane
MAHARASHTRA |
09870127812
manjyotgautam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy male/ female adult participants aged between 25 to 75 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Silicone sunscreen gel |
Fingertip units every 3 hours a day upto 45 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy adult (25-75 years).
2.Participants whose Fitzpatrick Skin Type 2, 3, or 4 (Questionnaire score 8-30).
Willingness to follow the protocol requirements as evidenced by written informed consent including:
3.Apply sunscreen on exposed skin.
4.Avoid sun/UV (including tanning beds) exposure between visits.
5.Dress to expose test areas during visits.
6.Long hair pulled back in a ponytail for Visit 2.
7.No new skincare products/brands during the study.
8.Participants or LAR can and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
9.Apply investigational product until Day 45 ± 4. |
|
| ExclusionCriteria |
| Details |
1.Participants having any clinically significant medical history, medical finding including rosacea, eczema, psoriasis, and atopic dermatitis or an on-going medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol
2.Participants having a history of hypersensitivity reactions (i.e., allergic or oversensitivity to usual doses).
3.Participants who have participated in a clinical study during the preceding 180 days.
4.Participants with a medical history of using a medicated acne treatment within the last 6 months.
5.Participants with active skin disease in the test area.
6.Participants on systemic therapy with immuno-suppressive drugs (e.g., corticosteroids) and/or antihistamines within 7 days prior to the start of the study and/or throughout the entire course of the study.
7.Participants who had an aesthetic, cosmetic or dermatological treatment in the treatment area (face) within the last month.
8.On the morning of or during study visits: has applied a topical product (including sunscreen, moisturizers, makeup, etc.) to the areas of skin to be evaluated (other than provided sunscreen, if applicable)
9. Participants with a known or suspected intolerance, allergy, or hypersensitivity to study materials (or closely related compounds) or any of their stated ingredients.
10.Participants with a history of allergies to cosmetic products or medicated acne treatments.
11.A history of abnormal responses to sunlight (e.g. phototoxic or photoallergic response).
|
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in clinical erythema assessment scores before and after application of sunscreen, from Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) to Visit 3 (Day 445 ± 4) |
Baseline, Day 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cosmetic acceptability by patients at day 45 assessed using a 7-item questionnaire with each question ranked on a 10-point scale score (1=Not at all, and 10=Worst possible condition). Total highest score can be 100 indicating worst acceptability and lowest score of 10 indicating best acceptability by the patient. |
Day 45 |
| Patients’ Global Improvement (PAGI) |
Day 45 |
| Local Skin Reactions (ICDRG) |
Day 45 |
| Cosmetic Acceptability |
Day 45 |
| Global Aesthetic Improvement Score (GAIS) |
Day 45 |
| Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE) over 45 days treatment period |
Day 45 |
| Compliance (treatment formulation) if participant achieved 80% of expected applications. |
Day 15, Day 45 |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
03/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
- All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study.
- Subjects will be informed about the purpose of the study and signed informed consent will be taken.
- All subjects will be followed up during the study period (visit 1 (screening visit/enrolment visit/ baseline visit- day 1), visit 2 (day 15 ± 4 days), and visit 3 (day 45 ± 4) days.
- The Adverse events, either spontaneously reported by the patient, or noticed by the clinician will be recorded during the study.
|