Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

12 november 2018 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

98

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Pennsylvania
      • Wayne, Pennsylvania, Förenta staterna, 19087
        • Aclaris Therapeutics, Inc.

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: A-101 Solution 40
A-101 Solution 40% administered once per week
Experimentell: A-101 Solution 45
A-101 Solution 45% administered once per week
Placebo-jämförare: Vehicle Solution
Vehicle Solution administered once per week

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Efficacy Based on Mean Change in Physician Wart Assessment Over Time
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

21 december 2015

Primärt slutförande (Faktisk)

16 september 2016

Avslutad studie (Faktisk)

16 september 2016

Studieregistreringsdatum

Först inskickad

28 januari 2016

Först inskickad som uppfyllde QC-kriterierna

29 januari 2016

Första postat (Uppskatta)

1 februari 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 december 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 november 2018

Senast verifierad

1 november 2018

Mer information

Termer relaterade till denna studie

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera