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

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ClinicalTrials.gov Identifier: NCT02669862
Recruitment Status : Completed
First Posted : February 1, 2016
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Common Warts Drug: A-101 Solution 40 Drug: A-101 Solution 45 Drug: Vehicle Solution Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Solution in Subjects With Common Warts.
Study Start Date : December 21, 2015
Actual Primary Completion Date : September 16, 2016
Actual Study Completion Date : September 16, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arm Intervention/treatment
Experimental: A-101 Solution 40
A-101 Solution 40% administered once per week
Drug: A-101 Solution 40
Experimental: A-101 Solution 45
A-101 Solution 45% administered once per week
Drug: A-101 Solution 45
Placebo Comparator: Vehicle Solution
Vehicle Solution administered once per week
Drug: Vehicle Solution



Primary Outcome Measures :
  1. Efficacy Based on Mean Change in Physician Wart Assessment Over Time [ Time Frame: 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.


Secondary Outcome Measures :
  1. Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13 [ Time Frame: 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

  2. PWA Responder [ Time Frame: Day 57 ]
    The percentage of participants who were responders with the target wart judged to be clear (PWA = 0) at Visit 10.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669862


Locations
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United States, Pennsylvania
Aclaris Therapeutics, Inc.
Wayne, Pennsylvania, United States, 19087
Sponsors and Collaborators
Aclaris Therapeutics, Inc.
Investigators
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Study Director: Stuart D Shanler, MD Aclaris Therapeutics, Inc.

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Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02669862     History of Changes
Other Study ID Numbers: A-101-WART-201
First Posted: February 1, 2016    Key Record Dates
Results First Posted: December 7, 2018
Last Update Posted: December 7, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Pharmaceutical Solutions