Efficacy Study & Safety Evaluation of SR-T100 Gel in Actinic Keratosis Treatment
17. Februar 2016 aktualisiert von: G&E Herbal Biotechnology Co., LTD
A Randomized, Double-Blind, Parallel, Vehicle-Controlled Phase III Trial to Assess the Efficacy and Safety of Topical SR-T100 Gel in the Treatment of Patients With Actinic Keratosis
Studies of SR-T100 gel and its clinical relevance in the treatment of AK, providing adequate measured outcomes for skin lesion treatment.
In addition to the high complete response rate (90.0%) as compared with the conventional therapy, the most significant result was that no undesirable side effects were associated with the use of SR-T100 gel.
The result also shows approximately 80% of study subjects had a complete response in phase II clinical trial conducted in Taiwan; hence, result from our study model suggested SR-T100 gel offers beneficial therapeutic values in treatment of AK is harmless to the skin as well as high tolerance level displayed by majority of patients.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The primary objective of this study is to demonstrate a clinically significant outcome involving SR-T100 topical gel developed against skin lesions such as AK.
Furthermore, evaluation of SR-T100 efficacy & tolerability in treating AK lesions are developed as secondary objective in this clinical study.
Patients with at least two clinically visible, discrete, non-hyperkeratotic, non-hypertrophic AK lesions on the arms, shoulder, chest, face and or scalp and at least one lesion of greater than or equal to 4mm in diameter within a total of 25 cm squared contiguous or non-contiguous treatment are expected to be enrolled.
Candidate pool is then divided into two groups with random assignments of treatment group or placebo group.
This randomization scheme will be generated by biostatistics and produced by a computer software program that incorporates a standard procedure for generating random probabilities.
Study procedures include laboratory testings, analytical readings as well as clinical assessment practices for treatment efficacy and safety evaluations.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
113
Phase
- Phase 3
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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Chiayi, Taiwan
- Chiayi Chang Gung Memorial Hospital
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Kaohsiung, Taiwan
- Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung, Taiwan
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung, Taiwan
- Kaohsiung Veterans General Hospital
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Tainan, Taiwan
- National Cheng Kung University Hospital
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Tainan, Taiwan
- Chi Mei Medical Center YongKang
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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
20 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
Male or female is 20 years of age or above and patient has at least two clinically visible, discrete, non hyperkeratotic, hypertrophic AK lesions located within a 25 cm squared contiguous or non contiguous treatment area including the arms, shoulder, chest, face and scalp. Patient has at least one histological confirmed actinic keratosis lesion of greater or equal to 4 mm in diameter within the selected treatment area.
Exclusion Criteria:
- Patient has any dermatological disease and condition, such as atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, melanoma, or other possible confounding skin conditions in the treatment or surrounding area within 5cm distances from treatment area.
- Patient had used the following treatments within 4 weeks prior to the study treatment initiation as immunomodulators or immunosuppressive therapy,interferon and cytotoxic drugs.
- Patient treated with topical 5 FU, diclofenac gel, imiquimod, corticosteroids, retinoids, masoprocol on the treatment area within 4 weeks prior to the study treatment initiation.
- Patient received cryodestruction, chemodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks prior to the study treatment initiation.
- Patient had received any of the following treatments on the treatment area in 6 months before study treatment initiation begins, such as psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion chemical peel.
- Patient is known to be hypersensitive to the study medication.
- Female who is pregnant, breast fed or considers of becoming pregnant while on the study.
- Patient had used of any investigational drug within the past 30 days before enrollment.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: SR-T100 gel
Patient group receiving medication SR-T100 gel with active ingredient under investigation, enrolled subjects randomly assigned to this group to accurately depict statistical significance of the measured outcome.
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Patient will be instructed to self-apply approximately 0.3~0.5g of SR-T100 gel on 25 cm squared treatment area (avoiding the periocular areas, lips, and nares) once daily with an occlusive dressing for 16 weeks treatment period.
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Aktiver Komparator: Vehicle gel
Patients given placebo with non-SR-T100 ingredients as they are being administered to patients, subjects are under random assignments from patient pool to depict statistically significant outcome measurement.
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Patient wil be instructed to self-apply approximately 0.3~0.5g of vehicle gel (without active ingredient)per total of 25 cm squared treatment area (avoiding the periocular areas, lips, and nares) once daily with an occlusive dressing for 16 weeks treatment period.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Comparison of SR-T100 gel effect with those of vehicle gel (Placebo) on efficacy and tolerability in patients with actinic keratosis
Zeitfenster: 24 weeks
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The primary objective is to compare the complete clearance rate between treatment groups at 8 weeks after the completion of 16 weeks study treatment.
The primary efficacy endpoint is to evaluate the complete clearance rate at 8 weeks after the completion of 16 weeks study treatment between treatment groups.
The complete clearance is defined as the absence of visible or palpable AK lesions in the treatment area
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24 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Evaluation of efficacy and tolerability of SR-T100 gel in AK treatment
Zeitfenster: 24 weeks
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SR-T100 clinical application in Actinic Keratosis treatment as direct proportional relationship to lesion size reduction, complete & partial clearance defined consequently as 100% & ≧75% reduction, coordinated toxicity & bio-safety reports supplements additional case study basis & foundation.
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24 weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Nützliche Links
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
1. Oktober 2011
Primärer Abschluss (Tatsächlich)
1. November 2015
Studienabschluss (Tatsächlich)
1. November 2015
Studienanmeldedaten
Zuerst eingereicht
15. Dezember 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
15. Dezember 2011
Zuerst gepostet (Schätzen)
16. Dezember 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
19. Februar 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
17. Februar 2016
Zuletzt verifiziert
1. Februar 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- GESRTAKA
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