CTRI/2025/02/080873尚未招募不适用
Effectiveness and Tolerability of Silicone Sunscreen Gel in Individuals for protection against ultraviolet radiation (UVA/UVB): An Observational Study
D9 Healthcare LLP1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2025年3月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •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
- •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.
排除标准
- •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)
- •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.
结局指标
主要结局
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)
时间窗: Baseline, Day 45
次要结局
- Compliance (treatment formulation) if participant achieved 80% of expected applications.(Day 15, Day 45)
- 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)
研究者
Dr Manjyot Gautam
D. Y. Patil Deemed to be University, School of Medicine, Navi Mumbai
研究点 (1)
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