Eine Studie zur Bewertung der Hautreizung und Sensibilisierung durch Selegilin TDS bei gesunden Probanden
Bewertung des Reiz- und Sensibilisierungspotenzials eines transdermalen Selegilin-Abgabesystems (6 mg/24 h) im Vergleich zu einem Referenzprodukt (EMSAM® 6 mg/24 h)
The two products used in this study are transdermal patches that contain selegiline. The test drug is the Selegiline Transdermal Delivery System (TDS). The comparator drug is the EMSAM® TDS.
The purpose of this research study is to compare how the skin tolerates the test TDS and the comparator TDS. The study will evaluate and compare skin irritation and possible allergic-type skin reactions (sensitization) caused by the two products.
The comparison will be based on how the skin responds to repeated applications of each TDS. This includes the assessment of skin irritation during the Induction Period and the evaluation of possible allergic or sensitization reactions after the Challenge Period. In addition, the adhesion of each patch (how well the patch sticks to the skin over time) will be regularly checked, as this is important for both product performance and skin safety.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This is a multi-center, evaluator-blinded, randomized phase 1 study evaluating skin irritation and skin sensitization of Selegiline transdermal system in comparison to EMSAM® transdermal patch in healthy volunteers. The study will consist of a 4-week Screening Phase and a Treatment Phase. The Treatment Phase will consist of the following periods: an Induction Period, a Rest Period followed by a Challenge Period and if needed, a Re-Challenge Period.
Trained study staff will examine the patch application sites at scheduled time points and will score any skin reactions using standardized assessment scales. In addition, photographs of the patch application site will be taken to document adhesion status while the patch is being worn.
Furthermore, the overall safety of the test product will be compared with that of the comparator product by monitoring and recording any adverse events, side effects, or discomfort experienced during the study.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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-
-
Elin Pelin, Bulgarien, 2100
- MHAT Skin Systems EOOD
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Sofia, Bulgarien, 1202
- Diagnostic & Consultative Center "Ascendent" Ltd.
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Sofia, Bulgarien, 1404
- Medical Center Neovitro
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion criteria:
- Male or female non-smoking subject.
- Lack of clinically significant abnormalities in health assessments performed at screening as deemed by the Investigator (or designee)
- BMI within the range (including the borders) of 18.5 to 29.9 kg/m2
Exclusion criteria:
- Medical history or presence of ANY current dermatological condition such as atopy, psoriasis, eczema, chronic or atopic dermatitis, vitiligo, or urticaria which, in the opinion of the Investigator, would compromise the safety of the subject or the integrity of the study
- Medical history or current evidence, as determined by the Investigator, of chronic infectious disease, system disorders, seizure disorders, or cardiovascular disorders (especially hypertension or family history of sudden cardiac death)
- Medical history of a condition that would significantly influence the immune response (e.g., primary or acquired immunodeficiencies such as HIV or AIDS; allergic diseases such as anaphylaxis, asthma, or generalized drug reaction; neoplasms such as lymphoma or leukemia; rheumatoid arthritis; or systemic lupus erythematosus)
- Clinically significant illness within 4 weeks before screening visit
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: 1/2 Selegiline TDS on left arm, 1/2 EMSAM® TDS on right arm
|
1/2 Selegiline TDS patch 6 mg/24 hours and 1/2 EMSAM® patch 6 mg/24 hours will be administered simultaneously |
|
Sonstiges: 1/2 Selegiline TDS on right arm, 1/2 EMSAM® TDS on left arm
|
1/2 Selegiline TDS patch 6 mg/24 hours and 1/2 EMSAM® patch 6 mg/24 hours will be administered simultaneously |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Assessment of irritation
Zeitfenster: From enrollment through the induction, challenge and potential rechallenge phases, up to 15 weeks.
|
Mean Irritation Score (MIS) |
From enrollment through the induction, challenge and potential rechallenge phases, up to 15 weeks.
|
|
Assessment of sensitization
Zeitfenster: From enrollment through induction, challenge and potential re-challenge phase, up to 15 weeks.
|
Number and proportion of subjects sensitized and potentially sensitized to each TDS unit |
From enrollment through induction, challenge and potential re-challenge phase, up to 15 weeks.
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- P-25-0012
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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