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

Kenvue Brands LLC

Status: Completed

Conditions: Oily Skin Aging

Treatments: Other: Sunscreen A use

Study type: Interventional

Funder types: Industry

Identifiers

NCT07310706

CS2025SK100253

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 30 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

Group I: 30 to 44 years of age

Experimental group

Description:

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

Treatment:

Other: Sunscreen A use

Group II: 45 to 55 years of age

Experimental group

Description:

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

Treatment:

Other: Sunscreen A use