A Study to Evaluate the Efficacy of a Facial Sunscreen in Adult Participants With Oily Skin and S… (NCT07310706) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Efficacy of a Facial Sunscreen in Adult Participants With Oily Skin and Signs of Aging
Brazil73 participantsStarted 2025-08-21
Plain-language 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.
Who can participate
Age range30 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
✓. 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:
✓. 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);
What they're measuring
1
Clinical efficacy of the use of Investigational Product on signs of facial aging via dermatological evaluation
Timeframe: Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use
2
Clinical efficacy of Investigational Product in reducing skin oiliness via dermatological evaluation
Timeframe: Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use
3
Clinical efficacy of Investigational Product in reducing pores
Timeframe: Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use
4
Efficacy perceived by the participant through a questionnaire assessment
Timeframe: Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use
5
Clinical efficacy of the use of Investigational Product on signs of facial aging
Timeframe: Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use
6
Clinical efficacy of the use of Investigational Product on signs of facial aging via image analysis
Timeframe: Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use
7
Clinical efficacy of Investigational Product in reducing skin oiliness via instrumental measurements
✕. 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:
✕. 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;
Timeframe: Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use