Eight-Week, Single-Site Study to Evaluate the Efficacy of a Facial Sunscreen in Adult Participants With Oily Skin and Signs of Aging
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kenvue Brands LLC
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Clinical efficacy of the use of Investigational Product on signs of facial aging via dermatological evaluation
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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;
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Clinical efficacy of the use of Investigational Product on signs of facial aging via dermatological evaluation
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)