A Study to Assess Effect of Two Facial Sunscreens in Impr... | NCT05864417

NCT05864417

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
CCSSKA005235	Other Identifier	Johnson & Johnson Consumer Inc.

Status Module

Label	Type	Description	Intervention Names
Sunscreen	Experimental	Participants will choose one facial sunscreen (SPF 70) out of the two (one with a light tone [Color 2.0] and another with a medium tone [Color 3.0]) based on the tone that best suits their skin color. At home, they will apply a generous amount of facial sunscreen to the face twice daily and will reapply when they feel the need up to 84 + (-) 2 days.	Other: Sunscreen Color tone 2.0 Other: Sunscreen Color tone 3.0

Name	Type	Description	Arm Group Labels	Other Names
Sunscreen Color tone 2.0	Other	Participants will topically apply sunscreen color tone 2.0.	Sunscreen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events	Number of participants with adverse events will be reported. An adverse event is any untoward medical occurrence in a clinical study participant temporally associated with the clinical investigation, whether or not the event has a causal relationship to the participants' participation in the trial. It is therefore any unfavorable and unintended sign (including an abnormal finding), symptom, or disease that occurs during the trial. This can include any occurrence that is new in onset, an aggravation of severity/ frequency of a baseline condition, or abnormal results of diagnostic procedures, including laboratory test abnormalities.	Up to 84 +/- 2 days
Improvement in Assessment of Melasma Color Intensity Using Chroma Meter CR 400 at Day 28	Melasma color intensity will be measured using chroma meter. Measurements will be performed both in area with melasma chosen by dermatologist, as documented in CRF during the eligibility assessment, and in an adjacent region (without the presence of melasma). Statistical improvement will be measured as (reduction in value of "b" parameter and increase in value of "L" and ITA parameters) versus baseline (D1) and Day 28 by an Anova model followed by Fisher's least significant difference (LSD) multiple comparison test. The color space L , a , b * was developed as a method of expressing colors in terms of numbers. The color space corresponds to perceived color characterization. L * stands for brightness (100 corresponds to white and 0 corresponds to black and b * indicates blue-yellow coloration. By determining values L * and b * of a color, it is possible to calculate individual topology angle (ITA). The lighter the skin, the higher the ITA.	Baseline and Day 28
Improvement in Assessment of Melasma Color Intensity Using Chroma Meter CR 400 at Day 56	Melasma color intensity will be measured using chroma meter. Measurements will be performed both in area with melasma chosen by dermatologist, as documented in CRF during the eligibility assessment, and in an adjacent region (without the presence of melasma). Statistical improvement will be measured as (reduction in value of "b" parameter and increase in value of "L" and ITA parameters) versus baseline (D1) and Day 28 by an Anova model followed by Fisher's LSD multiple comparison test. The color space L , a , b * was developed as a method of expressing colors in terms of numbers. The color space corresponds to perceived color characterization. L * stands for brightness (100 corresponds to white and 0 corresponds to black and b * indicates blue-yellow coloration. By determining values L * and b * of a color, it is possible to calculate ITA (individual topology angle). The lighter the skin, the higher the ITA.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and/or Female
Participants of any ethnicity according to IBGE criteria
From 35 years of age
Fitzpatrick Skin Type II to IV
Participant presenting mild to moderate melasma (grade 1 to 2 - according to the Site's scale), proven by a dermatologist
Participant's presenting wrinkles/fine lines in any region of the face (periorbital, frontal and/or nasolabial) from grade 2 to 6 (according to the Site's scale), confirmed by the dermatologist
Generally in good health based on medical history reported by the participant
Able to read, write, speak, and understand Portuguese
For Male Participants: agree to shave 24 hours before visits 1 to 4
Individual has signed the following informed consent documents (ICD):ICD, Informed Consent Image Disclosure (ICID) e Informed Consent for Cession of Rights for Image Use (ICCRIU)
Intends to complete the study and is willing and able to follow all study instructions

Exclusion Criteria:

Has known allergies or adverse reactions to common topical skincare products including sunscreen
Presents with a skin condition that may confound the study results (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer)
Presents with primary/secondary lesions (example scars, ulcers, vesicles) or tattoos on test sites
Participants with immune deficiency
Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication
Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including - immunosuppressive or steroidal drugs within 2 months before Visit 1, 2; non-steroidal anti-inflammatory drugs within 5 days before Visit 1; antihistamines within 2 weeks before Visit 1
Start or change of hormone replacement therapy or contraceptive drug method in the last 03 months
Participants who are using or have used topical products such as Retin-A, Retin-A Micro, and Differin or any other topical retinoid on the face within 6 months prior to the study; or use of any oral retinoid within 1 year prior to the study
Participants who are using or have currently used any facial products containing active ingredients against spots and/or wrinkles: 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 'anti-aging' products or products capable of interfering with skin brightness/uniformity, or with spots, within 2 months prior to the start of the study
Participants who have used cosmetic products on the same area (face) with anti-spot and anti-wrinkle action, within 14 days before the beginning of the study
Participants who have undergone chemical and/or physical peeling, laser or similar aesthetic treatments within 6 months prior to the study
Participants who have undergone invasive cosmetic or dermatological treatment in the test area within 2 months before the start of the study or during the study
Intense sun exposure or tanning session up to 01 month before the initial evaluation or planned intense sun exposure or tanning session during the study
Present signs of intense tanning, according to the evaluation of the study physician
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 may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
Present excessive hair in the evaluation region that may interfere in the instrumental measurements. In the case of men, even in the presence of excessive hair in the beard region, they will be instructed to shave one day before the visit
Is simultaneously participating in any other clinical study;
Is an employee/contractor or immediate family member of the principal investigator (PI), Study Site, or Sponsor