None listed
Conditions
Interventions
Intervention1: Silicone sunscreen gel: Fingertip units every 3 hours a day upto 45 days
Sponsors
D9 Healthcare LLP
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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)Timepoint: Baseline, Day 45 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Day 45;Patients Global Improvement (PAGI)Timepoint: Day 45;Local Skin Reactions (ICDRG)Timepoint: Day 45;Cosmetic AcceptabilityTimepoint: Day 45;Global Aesthetic Improvement Score (GAIS)Timepoint: Day 45;Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE) over 45 days treatment periodTimepoint: Day 45;Compliance (treatment formulation) if participant achieved 80% of expected applications.Timepoint: Day 15, Day 45 | — |
Countries
India
Contacts
Public ContactDr Manjyot Gautam
D. Y. Patil Deemed to be University, School of Medicine, Navi Mumbai
Outcome results
None listed