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A Study of A-101 Solution in Subjects With Common Warts.

12 novembre 2018 mis à jour par: Aclaris Therapeutics, Inc.

A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Solution in Subjects With Common Warts.

This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups.

Aperçu de l'étude

Description détaillée

This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups. During Visit 1, the Investigator will identify 1 eligible common wart on the trunk or extremities on each subject. The wart will be treated up to a maximum of 8 times at 1 week intervals during the study.

Type d'étude

Interventionnel

Inscription (Réel)

98

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Pennsylvania
      • Wayne, Pennsylvania, États-Unis, 19087
        • Aclaris Therapeutics, Inc.

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. Subject is at least 18 years of age
  2. Subject has a clinical diagnosis of common warts
  3. 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).
  4. The Target Wart has a Physician Wart Assessment (PWA) ≥2
  5. 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
  6. Subject is non-pregnant and non-lactating
  7. 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
  8. Subject is willing and able to follow all study instructions and to attend all study visits
  9. Subject is able to comprehend and willing to sign an Informed Consent Form.

Exclusion Criteria:

  1. Subject has clinically atypical warts on the trunk or extremities
  2. Subject is immune compromised (due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
  3. Subject has a history of Human Immunodeficiency Virus (HIV) infection
  4. Subject has had any Human Papilloma Virus (HPV) vaccine within 1 year prior to enrollment
  5. 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)
  6. 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);
  7. 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

  8. 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)
  9. Subject has a history of sensitivity to any of the ingredients in the study medications
  10. 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
  11. Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to enrollment.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: A-101 Solution 40
A-101 Solution 40% administered once per week
Expérimental: A-101 Solution 45
A-101 Solution 45% administered once per week
Comparateur placebo: Vehicle Solution
Vehicle Solution administered once per week

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Efficacy Based on Mean Change in Physician Wart Assessment Over Time
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13
Délai: visit 10 to visit 13
Percentage of subjects whose target wart was clear at Visit 10 and who remained clear at Visit 13 for active treatment groups
visit 10 to visit 13
PWA Responder
Délai: Day 57
The percentage of participants who were responders with the target wart judged to be clear (PWA = 0) at Visit 10.
Day 57

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Directeur d'études: Stuart D Shanler, MD, Aclaris Therapeutics, Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

21 décembre 2015

Achèvement primaire (Réel)

16 septembre 2016

Achèvement de l'étude (Réel)

16 septembre 2016

Dates d'inscription aux études

Première soumission

28 janvier 2016

Première soumission répondant aux critères de contrôle qualité

29 janvier 2016

Première publication (Estimation)

1 février 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 décembre 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 novembre 2018

Dernière vérification

1 novembre 2018

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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