Eight-Week, Single-Site Study to Evaluate the Efficacy of a Facial Sunscreen in Adult Participants With Oily Skin and Signs of Aging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Clinical efficacy of the use of Investigational Product on signs of facial aging via dermatological evaluation
研究概览
简要总结
This is a Single-Site, open-label, randomized clinical study that aims to evaluate the efficacy of the investigational product in improving the signs of skin aging and reducing facial oiliness in a population from 30 to 55 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For group I: 30 to 44 years of age; For group II: 45 to 55 years of age;
- •Skin Type I to VI according to Fitzpatrick's classification. For each group:
- •I. Fitzpatrick I and II: at least 8 participants II. Fitzpatrick III and IV: at least 8 participants III. Fitzpatrick V and VI: at least 8 participants
- •Participants of any ethnicity according to IBGE criteria;
- •Participants with oily or combination skin and oily shine on the face, both self-declared (through applied questionnaire) and confirmed by the dermatologist (from 2 points for oil shine by the modified Griffith scale from 0 to 9) at inclusion. For group I: oiliness will also be confirmed by Sebumeter (value above 100 AU for inclusion);
- •Participants self-declared to have enlarged pores, confirmed by dermatologist;
- •Participants who show signs of mild to moderate aging (2 to 6 points for the parameters of wrinkles, fine lines, and skin roughness based on the modified Griffith scale of 0-9 points), confirmed by dermatologist at inclusion;
- •Participant reports, at the time of inclusion, that he/she is concerned with at least one of the following parameters related to the appearance of facial skin:
- •I. Fine lines II. Wrinkles III. Roughness/uneven texture
- •Good general health, based on participant-reported medical history;
- •Able to read, write, speak and understand Portuguese;
- •For male participants: agree to shave 48 hours before study visits;
- •Person who signed the ICF and ICIU;
- •Intend to complete the study and are willing and able to follow all the instructions of the study.
排除标准
- •Have known allergies or adverse reactions to common topical skin care products, including facial sunscreen;
- •Have a skin condition that may influence the outcome of the study (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer);
- •Present primary/secondary lesions (e.g., scars, ulcers, vesicles, irritation resulting from the removal of facial hair) in the test areas;
- •Report having Type 1 or Type 2 diabetes or taking insulin or other antidiabetic medication;
- •Using medications that could mask an adverse event (AE) or influence the results of the study, including:
- •Immunosuppressive or steroidal medications within 2 months prior to the first visit
- •Non-steroidal anti-inflammatory drugs within 5 days prior to the first visit
- •Antihistamines within 2 weeks prior to the first visit
- •Antibiotics (oral or topical), hormonal therapy (except hormonal contraception methods), insulin, inhaled steroids (except prescribed for temporary allergy relief) within 1 month prior to the first visit.
- •Participants who have undergone invasive aesthetic or dermatological treatments in the test area (face) within 2 months prior to the first visit;
- •Menopausal or postmenopausal women (except for perimenopausal women who are eligible for the study);
- •Presence of excess hair in the evaluation area (face) that may interfere with instrumental evaluations. In the case of men, they will be instructed to shave 48 hours before visits;
- •Use of any products that may interfere with study assessments, at the discretion of the dermatologist;
- •Participants who have undergone chemical and/or physical peeling, laser, or similar aesthetic treatments within 6 months prior to the study;
- •Participants who reported being pregnant, planning to become pregnant, or breastfeeding during the study;
- •Have a history of or currently have a health condition/situation that could put the subject at significant risk, confound the results of the study, or significantly interfere with their participation in the study;
- •Be simultaneously participating in another clinical study;
- •Be an employee/contractor or close relative of the PI, Study Site or Sponsor;
- •Participants who practice activities (leisure or work) with intense sun exposure;
- •Smoking participants (Note: participants living with smokers may be eligible, provided that, at the discretion of the investigator, the participant's exposure to cigarettes does not interfere with or confound the results of the study. The participant's coexistence with a smoker must be reported as informative data).
结局指标
主要结局
Clinical efficacy of the use of Investigational Product on signs of facial aging via dermatological evaluation
时间窗: Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use
It is expected to obtain statistical improvement (p≤0.05) in the evaluated attributes such as reduction of wrinkles, fine lines and roughness of the skin through the dermatological clinical evaluation of wrinkles, fine lines, and skin roughness parameters using the modified 10-point Griffith scale (from 0 to 9).
Clinical efficacy of Investigational Product in reducing skin oiliness via dermatological evaluation
时间窗: Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use
It is expected to obtain statistical improvement (p≤0.05) in the evaluated attributes such as reduction of oiliness, reduction of oiliness shine, reduction of the appearance of pores through the dermatological clinical efficacy of oil shine using the modified 10-point Griffith scale (from 0 to 9).
Clinical efficacy of Investigational Product in reducing pores
时间窗: Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use
It is expected to obtain statistical improvement (p≤0.05) in the evaluated attributes such as reduction of the appearance of pores through the dermatological clinical efficacy of pore appearance via modified 10-point Griffith scale (from 0 to 9).
Efficacy perceived by the participant through a questionnaire assessment
时间窗: Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use
Efficacy measured by the participant through a questionnaire evaluating: * clinical efficacy of the use of Investigational Product on signs of facial aging * clinical efficacy of Investigational Product in reducing skin oiliness * clinical efficacy of Investigational Product in reducing pores
Clinical efficacy of the use of Investigational Product on signs of facial aging
时间窗: Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use
Facial image captures using the COLORFACE equipment.
Clinical efficacy of the use of Investigational Product on signs of facial aging via image analysis
时间窗: Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use
It is expected to obtain statistical improvement (p≤0.05) in the evaluated equipment described below: \- Evaluation of the facial images by the ANTERA 3D equipment.
Clinical efficacy of Investigational Product in reducing skin oiliness via instrumental measurements
时间窗: Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use
It is expected to obtain statistical improvement (p≤0.05) in the evaluated attributes such as reduction of oiliness through the equipment below: * Instrumental measurements with the Sebumeter® equipment.
次要结局
- The clinical efficacy of Investigational Product in maintaining skin hydration(Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use)
- The clinical efficacy of Investigational Product in maintaining the skin barrier(Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use)