Post-inflammatory HyperpigmentationEl Porto Ex-USNCT07679945
A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants
A study testing Sunscreen untinted and Sunscreen tinted in people with Post-inflammatory Hyperpigmentation and Melasma, run by Kenvue Brands LLC at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-inflammatory Hyperpigmentation, Melasma, Solar Lentigo
- What is being tested?
- Sunscreen untinted and Sunscreen tinted
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jun 2026to 25 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand and follow study instructions
- Fitzpatrick skin types I-VI
- Presence of facial hyperpigmentation, such as:
- Mild to moderate melasma, or
- Visible dark spots (e.g., solar lentigines or post-inflammatory hyperpigmentation)
- Willing to comply with study procedures and product use
- For subjects in applicable groups: willing to use assigned sunscreen product
Who cannot join
- Known sensitivity or allergy to cosmetic or skincare products
- Skin conditions or lesions in the study area that could interfere with evaluation (e.g., active dermatitis, infections, significant irritation, or extensive scarring)
- Use of medications or products that may interfere with study evaluations
- Recent cosmetic or dermatological procedures in the study area (e.g., chemical peels, laser treatments, invasive procedures)
- Excessive sun exposure or use of tanning beds immediately prior to or during the study
- Pregnancy or intention to become pregnant during the study
- Participation in another clinical study within a recent period
- Any condition or situation that, in the investigator's judgment, may interfere with study participation or evaluation of results
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
ALS Beauty & Personal Care Ltda
Campinas, São Paulo, 13084-791
Gabrielli Brianezi, +551937898600, gabrielli.brianezi@alsglobal.com
About this study
Official title: A Monocentric and Open-Label Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Research Participants
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.
- Conditions
- Post-inflammatory Hyperpigmentation, Melasma, Solar Lentigo
- Being tested
- Sunscreen untinted, Sunscreen tinted
- Medical subject headings
- Hyperpigmentation, Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunscreen untintedOther
Participants will apply the facial sunscreen on the face at least twice daily for 56 days
Sunscreen tintedOther
Participants will apply the facial sunscreen on the face at least twice daily for 56 days
| Study group | Role | What they receive |
|---|---|---|
| Group I: Melasma/Untinted | Experimental | Not described Receives: Other: Sunscreen untinted |
| Group I: Melasma/Tinted | Experimental | Not described Receives: Other: Sunscreen tinted |
| Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Untinted | Experimental | Not described Receives: Other: Sunscreen untinted |
| Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Tinted | Experimental | Not described Receives: Other: Sunscreen tinted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy of change in hyperpigmentation assessed via dermatological evaluation
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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").
Measured: 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.
Measured: After Visit 4 (56+2 days) of IP use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start2 Jun 2026
- Primary completion25 Sep 2026 (estimated)
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-inflammatory HyperpigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kenvue Brands LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679945
- Sponsor's protocol ID
- CS2026SK100350
- Acronym
- El Porto Ex-US
- Status last verified
- 23 Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocentric and Open-Label Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Research Participants
- ClinicalTrials.gov ID
- NCT07679945
- Acronym / sponsor ID
- El Porto Ex-US / CS2026SK100350
- Conditions
- Post-inflammatory Hyperpigmentation, Melasma, Solar Lentigo
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Kenvue Brands LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I: Melasma/Untinted | Experimental | Other: Sunscreen untinted |
| Group I: Melasma/Tinted | Experimental | Other: Sunscreen tinted |
| Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Untinted | Experimental | Other: Sunscreen untinted |
| Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Tinted | Experimental | Other: Sunscreen tinted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Known sensitivity or allergy to cosmetic or skincare products
- Skin conditions or lesions in the study area that could interfere with evaluation (e.g., active dermatitis, infections, significant irritation, or extensive scarring)
- Use of medications or products that may interfere with study evaluations
- Recent cosmetic or dermatological procedures in the study area (e.g., chemical peels, laser treatments, invasive procedures)
- Excessive sun exposure or use of tanning beds immediately prior to or during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sunscreen untintedParticipants will apply the facial sunscreen on the face at least twice daily for 56 days | Other | Group I: Melasma/Untinted, Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Untinted |
| Sunscreen tintedParticipants will apply the facial sunscreen on the face at least twice daily for 56 days | Other | Group I: Melasma/Tinted, Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Tinted |
Primary outcome
Clinical efficacy of change in hyperpigmentation assessed via dermatological evaluation
Time frame: 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)
Time frame: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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).
Capture of facial images using the Visia-CR® Facial Imaging Booth (Canfield Scientific, Inc.)
Time frame: 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
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.
Participants' quality of life regarding facial spots for participants with Melasma assessed through a Quality of Life Questionnaire (MELASQoL)
Time frame: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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.
Participants' quality of life regarding facial spots for participants with Solar Lentigo or Post-Inflammatory Hyperpigmentation assessed through a Quality of Life Questionnaire (DLQI)
Time frame: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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.
Perceived efficacy assessed through perception questionnaires completed by the research participants
Time frame: After Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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").
Open emotional testimonial written by the participant at the end of IP use
Time frame: After Visit 4 (56+2 days) 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunscreen untinted and Sunscreen tinted in people with Post-inflammatory Hyperpigmentation and Melasma, run by Kenvue Brands LLC at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kenvue Global Clinical Operations (18779295131, KenvueClinical_KV@kenvue.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy of change in hyperpigmentation assessed via dermatological evaluation (time frame: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.