Clinical trial NCT05972434: 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
Official title: A Single-Center, Open-Label Safety-in-Use Clinical Trial to Assess the Topical Tolerability and Efficacy in Improving Hydration, Skin Barrier Function, and Skin Tone Uniformity of Two Facial Sunscreens (IPs) Under Controlled and Normal Conditions of Use on the Face by Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2023-08-02
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Groups 1 and 2: Skin Hydration as Assessed Through Instrumental Corneometry Measurements During 12 Hours of Visit 2
timeFrame: 0 hour, 2 hours, 4 hours, 6 hours, 8 hours and 12 hours (Visit 2)
measure: Groups 1 and 2: Skin Hydration as Assessed Through Instrumental Skin Corneometry Measurements at Day 28 +/- 2
timeFrame: Up to Day 28 +/- 2
measure: Groups 1 and 2: Skin Barrier Integrity as Assessed Through Tewameter Measurements
timeFrame: Day 28 +/- 2
measure: Groups 1 and 2: Participant's Self-perceived Efficacy Questionnaire to Assess Clinical Effectiveness
timeFrame: Day 28 +/- 2
measure: Group 1:Percentage of Participants with Adverse Events
timeFrame: Up to 28 +/- 2 days
measure: Group 2: Facial Skin Tone as Assessed Through Radiance/Brightness/Luminousness Scale
timeFrame: Up to Day 56 +/- 2
measure: Group 2: Facial Skin Tone as Assessed Through Skin Tone Uniformity/Homogeneity Scale
timeFrame: Up to Day 56 +/- 2
measure: Group 2: Facial Skin Tone as Assessed Through Image Analysis via Colorface
timeFrame: Day 56 +/- 2
measure: Group 2: Testimonial Regarding the Experience with Sunscreen
timeFrame: Day 56
measure: Group 2:Percentage of Participants with Adverse Events
timeFrame: Up to 56 +/- 2 days
measure: Group 2: Participant's Self-perceived Efficacy Questionnaire to Assess Clinical Effectiveness
timeFrame: Day 56 +/-2
Secondary outcomes:
measure: Group 1 and 2: Skin Hydration as Assessed by Hydration Map
timeFrame: Up to Day 28+/- 2 days
measure: Group 1: Skin Hydration as Assessed Through Instrumental Forearms Corneometry Measurements During 12 Hours of Visit 2
timeFrame: 0 hour, 2 hours, 4 hours, 6 hours, 8 hours and 12 hours (Visit 2)
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa Pesquisa Dermato-Cosmética Ltda
state: Sao Paulo
Study officials:
affiliation: Allergisa Pesquisa Dermato-Cosmética Ltda
name: Gabrielli Brianezi
role: PRINCIPAL_INVESTIGATOR
References: