- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02669862
A Study of A-101 Solution in Subjects With Common Warts.
A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Solution in Subjects With Common Warts.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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-
Pennsylvania
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Wayne, Pennsylvania, Stati Uniti, 19087
- Aclaris Therapeutics, Inc.
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Subject is at least 18 years of age
- Subject has a clinical diagnosis of common warts
Subject has 1 appropriate Target Wart as defined below, on the trunk or extremities:
- Have a longest axis that is 3mm to 10mm
- Have a thickness ≤3mm
- Be a discrete lesion
- Be, when centered in the circular cutout of the provided template, the only common wart present
- Not be periungual, subungual, genital or anal
- Not be covered with hair which, in the Investigator's opinion, would interfere with the study medication treatments or the study evaluations Not be in an area that may be occluded (by clothing, footwear or within a skin fold).
- The Target Wart has a Physician Wart Assessment (PWA) ≥2
- If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control for the duration of the study
- Subject is non-pregnant and non-lactating
- Subject is in good general health and free of any known disease state or physical condition which, in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations
- Subject is willing and able to follow all study instructions and to attend all study visits
- Subject is able to comprehend and willing to sign an Informed Consent Form.
Exclusion Criteria:
- Subject has clinically atypical warts on the trunk or extremities
- Subject is immune compromised (due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
- Subject has a history of Human Immunodeficiency Virus (HIV) infection
- Subject has had any Human Papilloma Virus (HPV) vaccine within 1 year prior to enrollment
Subject has used any of the following intralesional therapies within the specified period prior to enrollment to the Target Wart:
- Immunotherapy (Candida antigen, mumps antigen, Trichophyton antigen);
- Anti-metabolite therapy (bleomycin, 5-fluorouracil)
Subject has used any of the following systemic therapies within the specified period prior to enrollment:
- Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept, infliximab);
- Glucocortico-steroids (inhaled and intra-nasal steroids are permitted);
Subject has used any of the following topical therapies within the specified period prior to enrollment on, or in a proximity to the Target Wart, which in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations:
- LASER (pulsed-dye laser), light (intense pulsed light, photo-dynamic therapy, other energy based therapy); Immuno-therapy ( imiquimod, squaric acid dibutyl ester, etc.); Anti-metabolite therapy (5-fluorouracil); Retinoids; Liquid nitrogen, electrodesiccation, curettage; Over-the-counter wart therapies
Subject has had any of the following within the specified period prior to enrollment on, or in a proximity to the target lesion, which in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations:
- A cutaneous malignancy;
- A pre-malignancy (actinic keratosis)
- Subject has a history of sensitivity to any of the ingredients in the study medications
- Subject has any current skin disease (psoriasis, atopic dermatitis, eczema, sun damage, etc.), skin condition (sunburn, open wounds) or other disease or condition (uncontrolled diabetes) which, in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations
- Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to enrollment.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: A-101 Solution 40
A-101 Solution 40% administered once per week
|
|
|
Sperimentale: A-101 Solution 45
A-101 Solution 45% administered once per week
|
|
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Comparatore placebo: Vehicle Solution
Vehicle Solution administered once per week
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Efficacy Based on Mean Change in Physician Wart Assessment Over Time
Lasso di tempo: 57 Days
|
The primary effectiveness will consist of the mean change from Visit 2 to Visit 10 in Physician Wart Assessment (PWA) performed using Analysis of Covariance (ANCOVA) with Visit 2 PWA as the covariate.
Physician Wart Analysis is a measurement scale from 0 to 3 that evaluates the wart with 0 being clear and 3 being clinically diagnosable wart that is raised, with an obviously rough surface.
|
57 Days
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13
Lasso di tempo: visit 10 to visit 13
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Percentage of subjects whose target wart was clear at Visit 10 and who remained clear at Visit 13 for active treatment groups
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visit 10 to visit 13
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PWA Responder
Lasso di tempo: Day 57
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The percentage of participants who were responders with the target wart judged to be clear (PWA = 0) at Visit 10.
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Day 57
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Stuart D Shanler, MD, Aclaris Therapeutics, Inc.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- A-101-WART-201
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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