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

12. november 2018 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

98

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Pennsylvania
      • Wayne, Pennsylvania, Forenede Stater, 19087
        • Aclaris Therapeutics, Inc.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: A-101 Solution 40
A-101 Solution 40% administered once per week
Eksperimentel: A-101 Solution 45
A-101 Solution 45% administered once per week
Placebo komparator: Vehicle Solution
Vehicle Solution administered once per week

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Efficacy Based on Mean Change in Physician Wart Assessment Over Time
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13
Tidsramme: 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
Tidsramme: Day 57
The percentage of participants who were responders with the target wart judged to be clear (PWA = 0) at Visit 10.
Day 57

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Stuart D Shanler, MD, Aclaris Therapeutics, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

21. december 2015

Primær færdiggørelse (Faktiske)

16. september 2016

Studieafslutning (Faktiske)

16. september 2016

Datoer for studieregistrering

Først indsendt

28. januar 2016

Først indsendt, der opfyldte QC-kriterier

29. januar 2016

Først opslået (Skøn)

1. februar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. december 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. november 2018

Sidst verificeret

1. november 2018

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Almindelige vorter

Kliniske forsøg med A-101 Solution 40

Abonner