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

12 november 2018 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

98

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Pennsylvania
      • Wayne, Pennsylvania, Verenigde Staten, 19087
        • Aclaris Therapeutics, Inc.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: A-101 Solution 40
A-101 Solution 40% administered once per week
Experimenteel: A-101 Solution 45
A-101 Solution 45% administered once per week
Placebo-vergelijker: Vehicle Solution
Vehicle Solution administered once per week

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Efficacy Based on Mean Change in Physician Wart Assessment Over Time
Tijdsspanne: 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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie directeur: Stuart D Shanler, MD, Aclaris Therapeutics, Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

21 december 2015

Primaire voltooiing (Werkelijk)

16 september 2016

Studie voltooiing (Werkelijk)

16 september 2016

Studieregistratiedata

Eerst ingediend

28 januari 2016

Eerst ingediend dat voldeed aan de QC-criteria

29 januari 2016

Eerst geplaatst (Schatting)

1 februari 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 december 2018

Laatste update ingediend die voldeed aan QC-criteria

12 november 2018

Laatst geverifieerd

1 november 2018

Meer informatie

Termen gerelateerd aan deze studie

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Klinische onderzoeken op A-101 Solution 40

3
Abonneren