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Dermatological Acceptability and Efficacy in Improving Xerosis, Skin Hydration, and Barrier Function

15. September 2026 aktualisiert von: Brainfarma Industria Química e Farmacêutica S/A

Clinical, Subjective, and Instrumental Evaluation of Dermatological Acceptability and Efficacy in Improving Dryness, Hydration, and Skin Barrier Function in Participants With Xerosis

The goal of this clinical trial is to evaluate the dermatological safety and efficacy of a moisturizing product in participants with moderate to severe xerosis of the lower limbs. The main questions it aims to answer are:

  • Does the investigational product demonstrate dermatological acceptability and absence of irritation under real-world conditions of use?
  • Does the investigational product improve skin hydration after single and repeated applications?
  • Does the investigational product improve skin barrier recovery and strengthen skin barrier function?
  • How do participants perceive the performance and efficacy of the investigational product?

Participants will:

  • Apply the investigational moisturizing product twice daily for 28 days.
  • Undergo clinical dermatological evaluations to assess skin tolerability and potential irritation.
  • Undergo instrumental assessments of skin hydration using a Corneometer® and skin barrier function using a Tewameter®.
  • Complete questionnaires regarding product performance and perceived efficacy.

The study will enroll 22 male and female participants aged 35 to 65 years with clinically confirmed moderate to severe xerosis of the lower limbs.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

22

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

    • São Paulo
      • Osasco, São Paulo, Brasilien, 06023-070
        • Rekrutierung
        • Grupo Medcin
        • Kontakt:
        • Hauptermittler:
          • Sergio Schalka

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
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Inclusion Criteria:

  • Male and female participants aged 36 to 65 years.
  • Participants presenting moderate to severe xerosis of the lower limbs, corresponding to grades 2 or 3 on the Overall Dry Skin Score (ODS) scale, confirmed by clinical evaluation.
  • Participants presenting a stratum corneum hydration index between 35 and 55 arbitrary units (AU), as measured by corneometry on the forearm during the eligibility assessment.
  • Participants considered healthy by the investigator, with no medical conditions or use of medications that could pose an undue risk or interfere with the study results.
  • Willingness to comply with all study procedures and attend the study site on the scheduled dates and times for assessments.
  • Ability to understand the study requirements, provide written informed consent, and sign the Informed Consent Form (ICF).

Exclusion Criteria:

  • Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study, when applicable.
  • Use of anti-inflammatory, immunosuppressive, antihistamine, or any other medication that, in the investigator's opinion, may interfere with skin condition assessments or study outcomes.
  • Presence of skin marks in the test area that may interfere with clinical or instrumental evaluations of skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
  • Presence of active atopic dermatitis, eczema, or other dermatoses that may interfere with evaluation of the test area.
  • Active localized or generalized skin diseases and/or lesions in the assessment area that, in the investigator's opinion, may compromise participation in the study.
  • Immunosuppression due to medication use or active disease.
  • Uncontrolled endocrine disorders.
  • Presence of significant vascular alterations in the lower limbs, such as severe venous insufficiency, significant edema, lymphedema, or ulcers that may interfere with study assessments.
  • Relevant medical history or current evidence of alcohol or substance abuse.
  • Known history of or suspected intolerance to products of the same category.
  • Intense sun exposure within 15 days prior to the baseline assessment.
  • Aesthetic or dermatological treatments within 4 weeks prior to the baseline assessment.
  • Procedures that may temporarily alter skin condition in the test area, such as exfoliation or hair removal, within the timeframe specified by the study protocol.
  • Any other condition that, in the investigator's opinion, may pose a risk to the participant, interfere with protocol compliance, or compromise the interpretation of study results.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Investigational Product Group
Participants with moderate to severe xerosis of the lower limbs will apply the investigational moisturizing product twice daily for 28 days. Dermatological, subjective, and instrumental assessments will be performed to evaluate skin tolerability, hydration, and skin barrier function.
A topical moisturizing product intended for the management of xerosis. The product will be applied twice daily to the lower limbs for 28 consecutive days. Its dermatological acceptability, effects on skin hydration, and effects on skin barrier recovery and strengthening will be evaluated through clinical, subjective, and instrumental assessments, including Corneometer® and Tewameter® measurements.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Dermatological Acceptability Assessed by Clinical Dermatological Evaluation
Zeitfenster: Baseline and Day 28
Dermatological acceptability of the investigational product under real-world conditions of use, including the assessment of signs of skin irritation and participant-reported discomfort sensations. Evaluations will be performed by a dermatologist throughout the study period.
Baseline and Day 28

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Skin Hydration Assessed by Corneometer®
Zeitfenster: Immediately after application, 1 hour, 2 hours, 4 hours, 8 hours, 10 hours, 12 hours, 24 hours, and 48 hours after a single application.
Evaluation of skin hydration following a single application of the investigational product using Corneometer®. Skin hydration will be measured in arbitrary units (AU), with higher values indicating greater skin hydration.
Immediately after application, 1 hour, 2 hours, 4 hours, 8 hours, 10 hours, 12 hours, 24 hours, and 48 hours after a single application.
Skin Barrier Recovery Assessed by Tewameter® Following Tape Stripping
Zeitfenster: Immediately after application, 1 hour, 2 hours, and 4 hours after a single application.
Evaluation of skin barrier recovery following barrier disruption induced by tape stripping and a single application of the investigational product. Skin barrier function will be assessed using Tewameter® measurements of transepidermal water loss (TEWL). Lower TEWL values indicate improved skin barrier recovery and function.
Immediately after application, 1 hour, 2 hours, and 4 hours after a single application.
Perceived Product Performance Assessed by a Perceived Efficacy Questionnaire Following Tape Stripping
Zeitfenster: Immediately after application, 1 hour, and 2 hours after a single application.
Evaluation of the performance and attributes of the investigational product using a perceived efficacy questionnaire following skin barrier disruption induced by tape stripping and a single application of the product. Participants will report the intensity of symptoms and sensations, such as burning sensation, using response categories ranging from "Absent" to "Very Intense."
Immediately after application, 1 hour, and 2 hours after a single application.
Skin Barrier Strengthening Assessed by Tewameter®
Zeitfenster: Day 7 and Day 28
Evaluation of skin barrier strengthening following continuous use of the investigational product. Skin barrier function will be assessed using Tewameter® measurements of transepidermal water loss (TEWL) after 7 and 28 days of product use. Lower TEWL values indicate improved skin barrier function and strengthening of the skin barrier.
Day 7 and Day 28
Skin Hydration Assessed by Corneometer®
Zeitfenster: Day 7 and Day 28
Evaluation of the efficacy of the investigational product in improving skin hydration following continuous use. Skin hydration will be measured using Corneometer® and reported in arbitrary units (AU). Higher values indicate greater skin hydration and a better outcome.
Day 7 and Day 28
Perceived Product Performance Assessed by a Perceived Efficacy Questionnaire
Zeitfenster: Day 7 and Day 28
Evaluation of the performance and attributes of the investigational product using a perceived efficacy questionnaire after 7 and 28 days of product use. Responses will be recorded using a 5-category agreement scale ranging from "Strongly Disagree" to "Strongly Agree."
Day 7 and Day 28

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Sergio Schalka, Grupo Medcin

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 (Geschätzt)

14. September 2026

Primärer Abschluss (Geschätzt)

17. November 2026

Studienabschluss (Geschätzt)

17. November 2026

Studienanmeldedaten

Zuerst eingereicht

10. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. September 2026

Zuerst gepostet (Tatsächlich)

15. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 26-0197-06

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

No plan has been established to share individual participant data (IPD) collected during this study. Participant confidentiality and privacy will be protected in accordance with applicable regulations and institutional policies.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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