A Study of Two Facial Sunscreens to Assess Its Effect in Improving Hydration, Skin Barrier Function, and Skin Tone Uniformity Under Controlled and Normal Conditions of Use on the Face by Adult Participants

Johnson & Johnson (J&J)

Status: Completed

Conditions: Healthy

Treatments: Other: Sunscreen B; Other: Sunscreen A

Study type: Interventional

Funder types: Industry

Identifiers

NCT05972434

CCSSKA005284 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of 02 facial sunscreens (investigational products [IPs]) under controlled and normal conditions of use on the face for 28 and 56 days, respectively. This study will consist of 2 groups a) Group 1: will assess the safety and efficacy of a facial sunscreen in improving skin hydration and barrier function, through 12h of single application on the face in comparison with the control area (other side of face) and on the forearm, comparing 02 IPs versus control area (no product application) and 03 benchmarks; and through use of the IP under normal conditions for 28 +/- 2 days on the face, with assessments by instrumental measurements of corneometry, transepidermal water loss, image capture (Colorface) and assessments of the efficacy perceived by the participant; b) Group 2: will evaluate the safety and efficacy of a facial sunscreen in improving skin hydration and barrier function, through 12h of single application on the face; and through use of IP under normal conditions for 28 +/- 2 days on the face, with assessments by instrumental measurements of corneometry, transepidermal water loss, imaging (Colorface) and assessments of the efficacy perceived by the participant; in addition to evaluating the improvement in uniformity of facial skin tone through the use of IP under normal conditions for 56 +/- 2 days, with assessments by image analysis (Colorface), dermatological clinical analyses (radiance and homogeneity of skin tone),assessments of perceived efficacy, and emotional testimony by the participant.

Enrollment: 82 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants of any ethnicity according to IBGE criteria
• Generally in good health based on medical history reported by the participant
• Able to read, write, speak, and understand Portuguese
• Capacity to consent to participation in the study
• Fitzpatrick Skin Type I to IV
• Intact skin in the test region
• Specific for Group 1: Participants with dry skin on the forearms (Corneometer score of maximum 40 arbitrary units (a.u.) at initial measurement before application of the products
• Participants with a maximum facial corneometry value of 60 a.u. at the initial measurement before the application of the products
• Participants presenting recent and repetitive complaints of discomfort caused by dry skin on the face, such as: pining, itching, irritation, et cetra
• Specific for Group 2: Participants who present lack of homogeneity in the tone of the facial skin due to hyperchromia caused by sun spots, solar lentigo, post-inflammatory hyperpigmentation, ephelid and mild melasma (proven by Dermatologist)
• Specific for Group 2: Participants who present lack of radiance in the skin (proven by Dermatologist)
• Individual who has signed the informed consent document (ICD) and image disclosure consent term (IDCT)
• Concordance to adhere to the procedures and requirements of the study and to attend the Site on the day(s) and time(s) determined for the evaluations
• For male participants: agree to shave 24 hours before visit 1, 2 and 3

Exclusion criteria

• Has known allergies or adverse reactions to common topical skin care products including sunscreen
• Presents with a skin condition that may confound the study results (specifically psoriasis, eczema, active atopic dermatitis, active skin cancer)
• Presents with primary/secondary lesions on test sites (example. scars, ulcers, vesicles, tattoos)
• Report having Type 1 or Type 2 diabetes or taking insulin or another anti-diabetic medication: presents immunological insufficiency; Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including; Immunosuppressive or steroidal drugs within 60 days before Visit 1; Non-steroidal anti-inflammatory drugs within 5 days before Visit 1; Antihistamines within 14 days before Visit 1
• Participants who are currently using or have recently used any facial products containing active skin barrier replacement and intense moisturizing ingredients such as: urea, ceramides, hyaluronic acid, glycerin, butters and oils, within 2 months prior to the start of the study
• Participants who have used cosmetic products for facial and body moisturizing (on the forearms) within 07 days prior to the start of the study
• Specific for Group 2: Participants who are using or have recently used any facial products containing active ingredients against spots: alpha or beta hydroxy acids (including salicylic acid), polyhydroxy acids, topical products containing retinol or retinol derivatives, hydroquinones, arbutin, niacinamide, N-acetylglucosamine, Thiamidol, kojic acid, azelaic acid, licorice extract, whitening peptides, vitamin C, or any other product capable of interfering with the uniformity of skin tone/spots, within 2 months prior to the start of the study
• Participants who have undergone invasive cosmetic or dermatological treatment in the test areas within 2 months prior to the start of the study or during the study
• Participants who are using any medication to treat diseases of the face or body
• Other diseases or medications that may directly interfere with the study or endanger the health of the research participant
• Is self-reported to be pregnant or planning to become pregnant during the study
• Has a history of or a concurrent health/other condition/situation which, in the opinion of the Study Physician, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
• Is simultaneously participating in any other study
• Is an employee/contractor or immediate family member of the principal investigator (PI), Study Site, or Sponsor
• Presents excessive hair in the evaluation regions that may interfere with the instrumental measurements. In the case of men, they will be instructed to shave 24 hours before the visit

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Group 1: Sunscreen A

Experimental group

Description:

Eligible study participants will receive a standard liquid soap to be used on the face and forearms for 3 full days for an initial washout period in place of their usual soap. On their next visit to site an amount of IP will be topically applied to malar on one side of the participant's face by a qualified technician and other side of face will remain without product application (used for control). Six areas will also be marked on inner side of participant's forearms, approximately 5 centimeter (cm) from cubital region. These areas will be randomized, with 1 area for control (without product application) and other 5 areas for product application, being each of them for 02 IPs (Facial Sunscreen A and Face Sunscreen B) and 3 benchmarks. The products will be applied topically only once in marked areas. Next, participants will use Facial Sunscreen A in normal conditions at home for 28 +/- 2 days and then make the last study visit to complete the final analysis.

Treatment:

Other: Sunscreen A

Group 2: Sunscreen B

Experimental group

Description:

Eligible study participants will receive a standard liquid soap to be used on the face for 3 full days for an initial washout period in place of their usual soap. On their next visit to the Site an amount of the IP will be topically applied to the malar on one side of the participants' face by a qualified technician and the other side of the face will remain without product application (used for control). On their next visit to the Site an amount of the IP will be topically applied to the malar on one side of the participants' face by a qualified technician and the other side of the face will remain without product application (used for control). From Visit 2 to visit 4 participants will use the IP (Face Sunscreen B) at home until 56 +/-2 days of use.

Treatment:

Other: Sunscreen B