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A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants (El Porto Ex-US)

25. juni 2026 oppdatert av: Kenvue Brands LLC

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

152

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Brasil
    • São Paulo
      • Campinas, São Paulo, Brasil, 13084-791

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Able to understand and follow study instructions
  2. Fitzpatrick skin types I-VI

  3. Presence of facial hyperpigmentation, such as:

    • Mild to moderate melasma, or
    • Visible dark spots (e.g., solar lentigines or post-inflammatory hyperpigmentation)
  4. Willing to comply with study procedures and product use
  5. For subjects in applicable groups: willing to use assigned sunscreen product

Exclusion Criteria:

  1. Known sensitivity or allergy to cosmetic or skincare products
  2. Skin conditions or lesions in the study area that could interfere with evaluation (e.g., active dermatitis, infections, significant irritation, or extensive scarring)
  3. Use of medications or products that may interfere with study evaluations
  4. Recent cosmetic or dermatological procedures in the study area (e.g., chemical peels, laser treatments, invasive procedures)
  5. Excessive sun exposure or use of tanning beds immediately prior to or during the study
  6. Pregnancy or intention to become pregnant during the study
  7. Participation in another clinical study within a recent period
  8. Any condition or situation that, in the investigator's judgment, may interfere with study participation or evaluation of results

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Group I: Melasma/Untinted
Annen: Sunscreen untinted
Participants will apply the facial sunscreen on the face at least twice daily for 56 days
Eksperimentell: Group I: Melasma/Tinted
Annen: Sunscreen tinted
Participants will apply the facial sunscreen on the face at least twice daily for 56 days
Eksperimentell: Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Untinted
Annen: Sunscreen untinted
Participants will apply the facial sunscreen on the face at least twice daily for 56 days
Eksperimentell: Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Tinted
Annen: Sunscreen tinted
Participants will apply the facial sunscreen on the face at least twice daily for 56 days

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinical efficacy of change in hyperpigmentation assessed via dermatological evaluation
Tidsramme: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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)
Tidsramme: 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).
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.)
Tidsramme: 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.
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)
Tidsramme: 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.
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)
Tidsramme: 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.
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
Tidsramme: 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").
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
Tidsramme: 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.
After Visit 4 (56+2 days) of IP use

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kenvue Brands LLC

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. juni 2026

Primær fullføring (Antatt)

25. september 2026

Studiet fullført (Antatt)

25. september 2026

Datoer for studieregistrering

Først innsendt

1. juni 2026

Først innsendt som oppfylte QC-kriteriene

25. juni 2026

Først lagt ut (Faktiske)

1. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. juni 2026

Sist bekreftet

23. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CS2026SK100350

Plan for individuelle deltakerdata (IPD)

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NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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