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 range
30 Years – 55 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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:
. 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;
7
Clinical efficacy of Investigational Product in reducing skin oiliness via instrumental measurements
Timeframe: Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use