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

NCT07310706 | Completed

• 1 other identifier: CS2025SK100253
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Oily Skin Aging

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• 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

Study Arms (2)

Group I: 30 to 44 years of age

EXPERIMENTAL

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

Group II: 45 to 55 years of age

EXPERIMENTAL

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

Interventions

Sunscreen A use OTHER

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."

Group I: 30 to 44 years of age; Group II: 45 to 55 years of age

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 self-declared to have enlarged pores, confirmed by dermatologist;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Kenvue Brands LLC: lead

Study Sites (1)

CIDP do Brasil Pesquisas Clínicas LTDA

Rio de Janeiro, 20231-048, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 30, 2025
• Study Start: August 21, 2025
• Primary Completion: October 16, 2025
• Study Completion: November 26, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12-18

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)