- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07695753
A Study to Evaluate the Ability of Sunscreen Products to Modulate the Effects of Deep UVA +/- HEV Blue Light Induced Pigmentation and Biomarkers of Cutaneous Oxidative Stress
8. Juli 2026 aktualisiert von: Kenvue Brands LLC
A Single Center, Controlled Study to Evaluate the Ability of Sunscreen Products to Modulate the Effects of Deep UVA +/- HEV Blue Light Induced Pigmentation and Biomarkers of Cutaneous Oxidative Stress
To assess the level of sub pigmentation following an acute exposure to a Deep Ultraviolet A and high energy Blue Light wavelengths (380-420 nm).
This study will compare the unprotected control with test products in Condition #1 and Condition #2 to assess pigmentation as well as cutaneous oxidative stress and inflammation biomarkers that occur with exposure to the same light regimen.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
22
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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New Jersey
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Union, New Jersey, Vereinigte Staaten, 07083
- SGS North America, Inc. - Union Research Center
-
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
Inclusion Criteria:
- Fitzpatrick Skin Type III or IV targeting to complete at least 5 subjects in each skin type.
- Has ITA (calculated per the method defined in ISO24442:2022) of 10.00° to 41.00° for each test site (average value from subsites 1 and 7 per site) , with no variation in ITA° greater than 5° between test sites (having uniform skin color over the whole test area).
- Agrees to receive artificial sunlight (UV) exposure on the back.
- Agrees to refrain from sun exposure on the back, use of tanning beds, and self-tanning lotions, creams, or sprays until the completion of the study.
- Generally in good health based on medical history reported by the subject.
- Able to read, write, speak, and understand English.
- Has signed the Consent for Photograph Release and ICD including Health Insurance Portability and Accountability Act (HIPAA) disclosure.
- Intends to complete the study and is willing and able to follow all study instructions.
Exclusion Criteria:
- Has known allergies or adverse reactions to latex, common topical skincare products, UV light, or ingredients in the ISMs.
- Has a history of abnormal responses to sunlight or UV radiation.
- Has been instructed by a physician, pharmacist, or health professional to avoid sunlight because of a medical condition and/or because of drug contraindications.
- Has a history of photosensitivity (a reaction to sunlight) disorders (including solar urticaria [hives], phototoxicity, photo-allergy, polymorphous light eruptions).
- Is regularly taking a medication with photosensitizing potential, such as high blood pressure medication, acne medications (e.g., Accutane), certain psychiatric medications (e.g., Thorazine, tricyclic anti-depressants), certain antibiotics (e.g., Cipro, tetracycline), antihistamines (e.g., Benadryl), Levulan, or Psoralen.
- Is regularly taking other medication that could affect the results of the study (e.g., corticosteroids, steroidal or nonsteroidal anti-inflammatory drugs [NSAIDs], antihypertensive drugs, steroid inhalers, drugs that induce skin coloring, etc.). Low dose aspirin (≤81mg per day) is acceptable.
- Has used a tanning bed/lamp, has had extended sun exposure of the test area (the lower back), or has participated in a UV exposure study within 4 weeks before Visit 1.
- Has a concurrent illness, a medical history of a disease/condition, or a pre-existing/dormant dermatologic condition (e.g., psoriasis, rashes, eczema, seborrheic, severe excoriations, skin infection [fungal, bacterial, or viral], etc.) that could interfere with the outcome of the study or increase health risk to the subject, as determined by the PI or designee.
- Via visible light and Wood's lamp evaluation: presence of sunburn, suntan, scars, tattoos, active dermal lesions, nevi, blemishes, moles, excessive tan spots from prior sunscreen testing, excessive hair, or uneven skin tone on the test area (back) that might interfere with the study.
- Has a history of immunosuppression/immune deficiency disorders (including HIV infection, AIDS, multiple sclerosis, Crohn's disease, rheumatoid arthritis), organ transplant (heart, kidney, etc.), and/or undergoing radiation or chemotherapy as determined by study documentation.
- 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:
- Non-steroidal anti-inflammatory drugs within 5 days before Visit 1.*
- Antihistamines within 14 days before Visit 1.*
- Antibiotics within 16 days prior to Visit 1.*
- Immunosuppressive drugs or steroidal drugs within 2 months before Visit 1.*
- Systemic or topical medication that is known to alter responses to UV radiation.* * If an individual is taking one of these medication types, the individual is not considered eligible at screening. However, if a subject begins using one of these medications during the study, the PI should be consulted to consider the impact of the specific medication on subject safety and/or the study results.
- Has a personal or family history of skin cancer.
- Has skeletal protrusions and/or extreme areas of curvature in the test area.
- Is self-reported to be pregnant, lactating, or planning to become pregnant during the study or within 30 days of study completion.
- 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 .
- Has shaved, waxed, and/or used any hair removal method on the test area (back) within 2 weeks before visit 1.
- Has applied any leave on product(s) on the test area within 24 hours before Visit 1.
- Is simultaneously participating in any other clinical study or has participated in any product-use study within 30 days prior to Visit 1.
- Has started a long-term medication within the last 2 months.
- Has started hormone replacement therapies (HRT) or hormones for birth control or menopause less than 3 months before study enrollment or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
- Is an employee/contractor of the PI, Study Site, or Sponsor or immediate family member of the PI, Study Site Personnel, or Sponsor
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: All Subjects (Condition #1)
A trained designee will mark four test sites on the subject's back.
Each test site will contain seven subsites: one on-irradiated control (subsite 1) and six subsites (subsites 2-7) designated for increasing light-radiation doses.
At Visit 1, the IPs will be applied under Condition #1.
Test site 1 will remain unprotected.
|
At Visit 1, the IPs will be applied under Condition #1.
After 24 hours, the test site will be cleaned, the same IP will be reapplied directly to the test site and allowed to air dry before irradiation.
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Experimental: All Subjects (Condition #2)
At Visit 2, Sunscreen A will be applied to test site 4 under Condition #2.
Test site 1 will remain unprotected.
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At Visit 2, Sunscreen A will be applied to site 4 under Condition #2.
The site will air dry before irradiation.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Clinical evaluation of pigmentation
Zeitfenster: Visit 2/Day 2 (15 Minutes Post-Irradiation timepoint only) and Visit 3 (18-22 Hours Post-Irradiation).
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Percent mean change from baseline analysis and comparison between test sites and between subsites .
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Visit 2/Day 2 (15 Minutes Post-Irradiation timepoint only) and Visit 3 (18-22 Hours Post-Irradiation).
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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SkinColorCatch measurements
Zeitfenster: Visit 1/Day1, Visit 2/Day2 (Pre- irradiation and 15 Minutes Post-Irradiation), and Visit 3/Day 3 (18-22 Hours Post-Irradiation).
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Percent mean change from baseline analysis and comparison between test sites and between subsites
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Visit 1/Day1, Visit 2/Day2 (Pre- irradiation and 15 Minutes Post-Irradiation), and Visit 3/Day 3 (18-22 Hours Post-Irradiation).
|
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Imaging of test sites
Zeitfenster: Visit 2/Day 2 (15 Minutes Post-Irradiation timepoint only) and Visit 3/Day 3(18-22 Hours Post-Irradiation).
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Percent mean change from baseline analysis and comparison between test sites and between subsites
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Visit 2/Day 2 (15 Minutes Post-Irradiation timepoint only) and Visit 3/Day 3(18-22 Hours Post-Irradiation).
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Tape stripping for protein analyses
Zeitfenster: Visit 3/Day 3 (18-22 Hours Post-Irradiation)
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Percent mean change from baseline analysis and comparison between test sites and between subsites.
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Visit 3/Day 3 (18-22 Hours Post-Irradiation)
|
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Skin swabbing for cutaneous biomarkers
Zeitfenster: Visit 3/Day 3 (18-22 Hours Post-Irradiation
|
Percent mean change from baseline analysis and comparison between test sites and between subsites.
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Visit 3/Day 3 (18-22 Hours Post-Irradiation
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
27. Oktober 2025
Primärer Abschluss (Tatsächlich)
6. Dezember 2025
Studienabschluss (Tatsächlich)
6. Dezember 2025
Studienanmeldedaten
Zuerst eingereicht
11. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. Juli 2026
Zuerst gepostet (Tatsächlich)
10. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
10. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. Juli 2026
Zuletzt verifiziert
6. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- CS2025SK100256
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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