A 4-weeks Comparative Study of Cosmetic Product Versus Standard Medical Care in Subjects With Seborrheic Dermatitis
4. Mai 2026 aktualisiert von: Pierre Fabre Dermo Cosmetique
A Randomized Comparative Study to Evaluate the Efficacy of the Shampoo RV5263A - WS0060 Applied for 4 Weeks in Adults Subjects With Recurrent Squamous States of Seborrheic Dermatitis in Comparison to Standard Medical Care and a Cosmetic Shampoo
The aim of this study is to evaluate, with clinical and biological assessment methods, the effectiveness of the tested cosmetic product applied during 4 weeks of intensive treatment and compared to a Standard Medical Care (medicine shampoo) and to a comparative cosmetic shampoo, on mild to moderate recurrent squamous states of seborrheic dermatitis.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This study is conducted as a monocentric, randomized, controlled and blinded-label study, in parallel groups.
A total number of 90 subjects included and randomized in 3 parallel groups:
- Test group RV5263A - WS0060 cosmetic product
- Comparative group: RV5263A - LC3302 cosmetic product
Standard medical care group
6 visits are planned:
- Visit 1: Inclusion (Day 1)
- Visit 2: Intermediate visit (Day 4)
- Visit 3: Intermediate visit (Day 7)
- Visit 4: Intermediate visit (Day 15 ± 1 day)
- Visit 5: Intermediate visit (Day 22 ± 3 days)
- Visit 6: End-of-study visit (Day 29 ± 3 days)
Studientyp
Interventionell
Einschreibung (Tatsächlich)
90
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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Poland
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Malbork, Poland, Polen, 82200
- Dr. E.Karamon Private Practice
-
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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
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- Male or Female aged between 18 and 70 years included
- Subject affiliated to a social security system or health insurance, or is a beneficiary if applicable
Subject having a squamous state of the scalp:
- clinically visible (Squire score ≥ 20),
- recurrent (at least twice a year)
- having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization
- Subject having a recent prescription of Standard Medical Care (Ketoconazole 2%) not yet initiated
- Subject accepting that according to the randomization, the Standard Medical Care can be possibly replaced by another shampoo, including neutral shampoo
- Subject having a maximum usual shampoo frequency of 3/week
Non Inclusion criteria
- Subject who, in the judgement of the investigator, is not likely to be compliant with study-related constraints and requirements
Subject having any other dermatologic condition than the studied squamous state on hair/ scalp and liable to interfere with the study assessments:
- alopecia having caused hair loss on the upper part of the scalp (Norwood Hamilton stage> III, Ludwig ≥ I-4, alopecia aerata, alopecia totalis)
- raised skin lesion, likely to be traumatized, …
- Subject having dermatological pathology or evolutive skin lesion on the scalp (contact dermatitis, psoriasis, severe excoriations, severe sunburn, cutaneous bacterial superinfection of the scalp clinically obvious ...)
- Topical treatment or product applied on the scalp within 2 weeks before the inclusion or planned during the study that can be active on squamous states or that can limit the effectiveness of the study product: anti-inflammatory drugs, ketoconazole, anti-dandruff shampoo, anti-fungal, rinse with vinegar, essential oils ...
- Any scalp dyeing (including henna), bleaching, perm, smoothing / straightening performed within 3 weeks before inclusion or planned during the study
- Any topical hair product (conditioner, serum, mask, gel, lacquer, wax, foam…) or water applied on the scalp between the last shampoo and the inclusion visit
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Testgruppe
|
Cosmetic product Thrice weekly applications
|
|
Sonstiges: Comparative group
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Cosmetic product Thrice weekly applications
|
|
Aktiver Komparator: Standard medical care group
|
Standard medical care applications
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Dandruff severity (Squire score) after 29 days of product application
Zeitfenster: Visit 1 (Day 1) and Visit 6 (Day 29 or early termination).
|
Dandruff severity (Squire score): clinical scoring (from 0 to 80) performed by the investigator
|
Visit 1 (Day 1) and Visit 6 (Day 29 or early termination).
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Dandruff severity (Squire score) after 4, 7, 15 and 22 days of product application
Zeitfenster: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), and Visit 5 (Day 22)
|
Dandruff severity (Squire score): clinical scoring (from 0 to 80) performed by the investigator
|
Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), and Visit 5 (Day 22)
|
|
Intensity of squamous global state
Zeitfenster: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
Intensity of the squamous state on a 4-point scale (from 0 to 3), performed by the investigator
|
Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
|
Irritation state score (erythema)
Zeitfenster: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
Erythema score on a 4-point scale (from 0 to 3), performed by the investigator
|
Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
|
Irritation state score (pruritus)
Zeitfenster: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
Mean pruritus felt on the last 3 days on a NRS (0-10), performed by the subject
|
Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
|
Irritation state score (burning sensation)
Zeitfenster: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
Burning sensation score, on a NRS (0-10), performed by the subject
|
Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
|
Immediate irritation state score (pruritus)
Zeitfenster: Immediately after the 1st application of product
|
Immediate pruritus felt, on a NRS (0-10), performed by the subject
|
Immediately after the 1st application of product
|
|
Immediate irritation state score (burning sensation)
Zeitfenster: Immediately after the 1st application of product
|
Immediate burning sensation score, on a NRS (0-10), performed by the subject
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Immediately after the 1st application of product
|
|
Investigator Global Assessment
Zeitfenster: Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
Investigator Global Assessment, on a 5-point scale (from 1 to 5), performed by the investigator
|
Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
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Subject Global Assessment
Zeitfenster: Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
Subject Global Assessment, on a 5-point scale (from 1 to 5), performed by the subject
|
Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
|
Evolution of squamous state (dandruff)
Zeitfenster: Visit 1 (Day 1), immediately after the 1st application, Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
Squamous state (dandruff) score, on a 4-point scale, (from 0 to 3), performed by the subject
|
Visit 1 (Day 1), immediately after the 1st application, Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
|
Evolution of discomfort
Zeitfenster: Visit 1 (Day 1), immediately after the 1st application, Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
Discomfort evolution, on a 4-point scale (from 0 to 3), performed by the subject
|
Visit 1 (Day 1), immediately after the 1st application, Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
|
Quality of Life, specific scalp questionnaire
Zeitfenster: Visit 1 (Day 1), Visit 4 (Day 15) and Visit 6 (Day 29 or early termination)
|
Scalpdex questionnaire, completed by the subject
|
Visit 1 (Day 1), Visit 4 (Day 15) and Visit 6 (Day 29 or early termination)
|
|
Quality of life, Chronic Itch Burden scale
Zeitfenster: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
Chronic Itch Burden questionnaire, completed by the subject
|
Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
|
Acceptability Questionnaire assessment
Zeitfenster: Immediately after the 1st application, Visit 4 (Day 15) and Visit 6 (Day 29 or early termination)
|
Acceptability questionnaire regarding the use of the product will be completed by the subject.
|
Immediately after the 1st application, Visit 4 (Day 15) and Visit 6 (Day 29 or early termination)
|
|
Recording of adverse events
Zeitfenster: From Visit 1 (Day 1) to Visit 6 (Day 29 or early termination)
|
Adverse events occurrence will be determined by the subject spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation
|
From Visit 1 (Day 1) to Visit 6 (Day 29 or early termination)
|
|
Illustration of subject's squamous state evolution
Zeitfenster: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
Standardized photographs of the subject's scalp of affected area for illustrative purpose only
|
Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
|
Strains of the scalp microbiota
Zeitfenster: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15)
|
Via cotton-swab sampling
|
Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15)
|
|
Scalp proteic markers
Zeitfenster: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15)
|
via cotton-swab sampling
|
Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15)
|
|
Molecular characterization of the scalp sebum
Zeitfenster: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
via cigarette paper sampling
|
Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
|
Molecular characterization of the scalp - lipids
Zeitfenster: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
via cigarette paper sampling
|
Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
|
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)
4. Februar 2025
Primärer Abschluss (Tatsächlich)
17. Juni 2025
Studienabschluss (Tatsächlich)
17. Juni 2025
Studienanmeldedaten
Zuerst eingereicht
4. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. Mai 2026
Zuerst gepostet (Tatsächlich)
8. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
4. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RV5263A20240639
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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