Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study aims to evaluate the efficacy of a facial sunscreen under two experimental conditions-untinted and tinted-in improving facial spots (melasma and solar lentigines/post-inflammatory hyperpigmentation) after 8 weeks of product use under normal conditions by adult participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I: Melasma/Untinted | Experimental |
| |
| Group I: Melasma/Tinted | Experimental |
| |
| Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Untinted | Experimental |
| |
| Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Tinted | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunscreen untinted | Other | Participants will apply the facial sunscreen on the face at least twice daily for 56 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical efficacy of change in hyperpigmentation assessed via dermatological evaluation | Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use | |
| Instrumental measurements with the Chroma Meter CR 400 (Konica Minolta) | Measurements will be taken using the Chroma Meter® CR 400 to evaluate the color intensity of the dark spot (Melasma, Solar Lentigo, or Post-Inflammatory Hyperpigmentation) in comparison to the measurement of an adjacent area (without a spot). | Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use |
| Capture of facial images using the Visia-CR® Facial Imaging Booth (Canfield Scientific, Inc.) | Facial images will be captured using the Visia CR® Facial Imaging Booth (Canfield Scientific, Inc.) for analysis of the intensity and size of the spot (Melasma, Solar Spot, or Post-Inflammatory Hyperpigmentation), as well as the overall uniformity of skin tone. | Before, immediately after the first application, and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use |
| Participants' quality of life regarding facial spots for participants with Melasma assessed through a Quality of Life Questionnaire (MELASQoL) | Melasma Quality of Life Scale (MELASQoL) will only be answered by participants enrolled in Melasma group. The participant will answer a questionnaire with 10 questions regarding the condition of their skin, using a rating scale from 1 to 7, in which: 1 means "not at all bothered" and 7 means "bothered all the time". A total score will be generated by summing the scores of the 10 questions answered by the participant. The total score ranges from 10 to 70. The lower the score, the better the participant's quality of life. | Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use |
| Participants' quality of life regarding facial spots for participants with Solar Lentigo or Post-Inflammatory Hyperpigmentation assessed through a Quality of Life Questionnaire (DLQI) |
Not provided
Not provided
Inclusion Criteria:
Able to understand and follow study instructions
Fitzpatrick skin types I-VI
Presence of facial hyperpigmentation, such as:
Willing to comply with study procedures and product use
For subjects in applicable groups: willing to use assigned sunscreen product
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kenvue Global Clinical Operations | Contact | 18779295131 | KenvueClinical_KV@kenvue.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ALS Beauty & Personal Care Ltda | Recruiting | Campinas | São Paulo | 13084-791 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sunscreen tinted | Other | Participants will apply the facial sunscreen on the face at least twice daily for 56 days |
|
Dermatology Life Quality Index (DLQI) will only be answered by participants selected for the Solar Lentigo/PIH Group. The participant will answer a questionnaire with 10 questions regarding the impact of their skin on their quality of life. Each question is scored on a four-point Likert scale: very much = 3 points, much = 2 points, a little = 1 point and nothing/not relevant = 0 points. Questions answered as nothing and not relevant are equivalent to 0 points. The total score ranges from 0 to 30. The lower the score, the better the participant's quality of life. |
| Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use |
| Perceived efficacy assessed through perception questionnaires completed by the research participants | Participants will answer a questionnaire evaluating their individual opinion about the Investigational Product used. Questionnaire consists of 9 questions which should be answered in a 5-point scale of agreement (such as ranging from "Strongly Disagree" to "Strongly Agree"). | After Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use |
| Open emotional testimonial written by the participant at the end of IP use | Consists of an open-ended, narrative question in which the participant provides a brief statement regarding their experience with the use of their respective Investigational Product. | After Visit 4 (56+2 days) of IP use |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided