A Study to Evaluate the Efficacy of a Facial Sunscreen in Adult Participants With Oily Skin and Signs of Aging

Eight-Week, Single-Site Study to Evaluate the Efficacy of a Facial Sunscreen in Adult Participants With Oily Skin and Signs of Aging

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 Overview

• Status: Completed
• Conditions: Oily Skin Aging
• Intervention / Treatment: Other: Sunscreen A use

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 20231-048
    • CIDP do Brasil Pesquisas Clínicas LTDA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. For group I: 30 to 44 years of age; For group II: 45 to 55 years of age;

2. 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

3. Participants of any ethnicity according to IBGE criteria;
4. 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);
5. Participants self-declared to have enlarged pores, confirmed by dermatologist;
6. 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;

7. 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

8. Good general health, based on participant-reported medical history;
9. Able to read, write, speak and understand Portuguese;
10. For male participants: agree to shave 48 hours before study visits;
11. Person who signed the ICF and ICIU;
12. Intend to complete the study and are willing and able to follow all the instructions of the study.

Exclusion Criteria:

1. Have known allergies or adverse reactions to common topical skin care products, including facial sunscreen;
2. Have a skin condition that may influence the outcome of the study (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer);
3. Present primary/secondary lesions (e.g., scars, ulcers, vesicles, irritation resulting from the removal of facial hair) in the test areas;
4. Report having Type 1 or Type 2 diabetes or taking insulin or other antidiabetic medication;

5. 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.
6. Participants who have undergone invasive aesthetic or dermatological treatments in the test area (face) within 2 months prior to the first visit;
7. Menopausal or postmenopausal women (except for perimenopausal women who are eligible for the study);
8. 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;
9. Use of any products that may interfere with study assessments, at the discretion of the dermatologist;
10. Participants who have undergone chemical and/or physical peeling, laser, or similar aesthetic treatments within 6 months prior to the study;
11. Participants who reported being pregnant, planning to become pregnant, or breastfeeding during the study;
12. 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;
13. Be simultaneously participating in another clinical study;
14. Be an employee/contractor or close relative of the PI, Study Site or Sponsor;
15. Participants who practice activities (leisure or work) with intense sun exposure;
16. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I: 30 to 44 years of age; Group I: 30 participants in the age group of 30 to 44 years old, being: At least 8 with skin type I and II on the Fitzpatrick scale; At least 8 with skin type III and IV on the Fitzpatrick scale; At least 8 with skin type V and VI on the Fitzpatrick scale	Other: Sunscreen A use; The application of the Investigational Product will be performed by the participant and supervised by a qualified technician at Visit 1 and by the participant in their home. Home use: The Investigational Product will be applied topically by the participant, following the following mode of use: "Apply an abundant amount (equivalent to one teaspoon) daily to the face and neck, at least twice a day, with reapplications whenever necessary."
Experimental: Group II: 45 to 55 years of age; Group II: 30 participants in the age group of 45 to 55 years old, being: At least 8 with skin type I and II on the Fitzpatrick scale; At least 8 with skin type III and IV on the Fitzpatrick scale; At least 8 with skin type V and VI on the Fitzpatrick scale	Other: Sunscreen A use; The application of the Investigational Product will be performed by the participant and supervised by a qualified technician at Visit 1 and by the participant in their home. Home use: The Investigational Product will be applied topically by the participant, following the following mode of use: "Apply an abundant amount (equivalent to one teaspoon) daily to the face and neck, at least twice a day, with reapplications whenever necessary."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical efficacy of the use of Investigational Product on signs of facial aging via dermatological evaluation	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).	Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use
Clinical efficacy of Investigational Product in reducing skin oiliness via dermatological evaluation	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).	Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use
Clinical efficacy of Investigational Product in reducing pores	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).	Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use
Efficacy perceived by the participant through a questionnaire assessment	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	Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use
Clinical efficacy of the use of Investigational Product on signs of facial aging	Facial image captures using the COLORFACE equipment.	Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use
Clinical efficacy of the use of Investigational Product on signs of facial aging via image analysis	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.	Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use
Clinical efficacy of Investigational Product in reducing skin oiliness via instrumental measurements	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.	Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The clinical efficacy of Investigational Product in maintaining skin hydration	It is expected to obtain statistical improvement (p≤0.05) in the evaluated attributes, such as skin hydration through the equipment and evaluations described below: - To evaluate the clinical efficacy of Investigational Product in maintaining skin hydration, by measurements with Corneometer® equipment.	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	It is expected to obtain statistical improvement (p≤0.05) in the evaluated attributes, such as reduction and/or maintenance of trans epidermal water loss through the equipment and evaluations described below: - To evaluate the clinical efficacy of Investigational Product in maintaining trans epidermal water loss with Tewameter equipment.	Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use

Collaborators and Investigators

• Sponsor: Kenvue Brands LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2025
• Primary Completion (Actual): October 16, 2025
• Study Completion (Actual): November 26, 2025

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 20, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2025
• Last Verified: December 18, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CS2025SK100253

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No