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Study of A-101 Topical Solution for the Treatment of Common Warts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03687372
Recruitment Status : Completed
First Posted : September 27, 2018
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

Brief Summary:
A Phase 3 Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts

Condition or disease Intervention/treatment Phase
Common Wart Drug: A-101 Other: vehicle Phase 3

Detailed Description:
A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 503 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The blinded vehicle solution is packaged to match the active study drug and will be stored under the same conditions.
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects With Common Warts
Actual Study Start Date : September 17, 2018
Actual Primary Completion Date : June 20, 2019
Actual Study Completion Date : September 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arm Intervention/treatment
Experimental: A-101
topical solution
Drug: A-101
hydrogen peroxide topical solution 45%
Other Name: hydrogen peroxide 45%

Vehicle
topical solution
Other: vehicle
vehicle as a topical solution
Other Name: isopropyl alcohol and sterile water




Primary Outcome Measures :
  1. The primary efficacy endpoint is the proportion of subjects whose identified common warts are determined to be clear on the PWA scale (PWA=0) [ Time Frame: Day 60 ]
    Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale.


Secondary Outcome Measures :
  1. Effectiveness of A-101 45% vs Vehicle [ Time Frame: Day 137 ]
    The proportion of subjects who achieve complete clearance of all identified warts (PWA=0)

  2. Effectiveness of A-101 45% vs Vehicle [ Time Frame: Day 137 ]
    Mean per subject Percent of treated warts that are clear (PWA=0)

  3. Effectiveness of A-101 45% vs Vehicle [ Time Frame: Day 60 ]
    Proportion of subjects with a single wart at baseline, whose wart is Clear (PWA=0)

  4. Onset of Action [ Time Frame: Day 137 ]
    Median time to achieve onset of Clearance (PWA=0) for all treated warts



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject or legal guardian is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
  2. Male or female ≥ 1 years old.
  3. Subject has a clinical diagnosis of common warts (verruca vulgaris).
  4. Subject has at least 1 and up to 6 clearly identifiable common warts located on the trunk or extremities that meet the requirements as defined below:

    1. Have a longest axis that is ≥3 and ≤8 mm and have a thickness of ≤3mm
    2. Be a discrete lesion, i.e. each wart meeting the entry criteria is clearly separated from other warts.
    3. Be present for at least 4 weeks
    4. Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
    5. Not be in an intertriginous fold
    6. Periungual, subungual, genital, anal, mosaic, plantar, flat and filiform warts are excluded from treatment and evaluation. If a subject has these types of warts, but also has warts that meet the inclusion criteria, the subject will NOT be excluded from the study.
  5. Each common wart identified for treatment must have a PWA ≥ 2.
  6. Subject's chemistry and complete blood count results are within normal limits.
  7. Subject is in good general health and free of any known disease state or physical condition.
  8. Subject is willing and able to follow all study instructions and to attend all study visits.
  9. Subject must be the only individual in a household participating in the study.

Exclusion Criteria:

  1. Subject has clinically atypical warts.
  2. Subject is immunocompromised (e.g., 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 6 months prior to Visit 1.
  5. Subject has used any of the following intralesional therapies within the specified period prior to Visit 2:

    • Immunotherapy (e.g., Candida antigen, mumps antigen, Trichophyton antigen); 8 weeks
    • Anti-metabolite therapy (e.g., bleomycin, 5-fluorouracil); 8 weeks
  6. Subject has used any of the following systemic therapies within the specified period prior to Visit 2:

    • Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept, infliximab); 16 weeks
    • Glucocorticosteroids (inhaled and intra-nasal steroids are permitted); 28 days
  7. Subject has used any of the following topical therapies within the specified period prior to Visit 2 on, or in the proximity to any of the common warts identified for treatment, that in the investigator's opinion interferes with the study medication treatment or the study assessments:

    • LASER, light or other energy-based therapy (e.g., intense pulsed light [IPL], photodynamic therapy [PDT]); 180 days
    • Immunotherapy (e.g., imiquimod, squaric acid dibutyl ester[SADBE], etc.) 12 weeks
    • Liquid nitrogen, electrodesiccation, curettage; 60 days
    • Hydrogen peroxide; 90 days
    • Antimetabolite therapy (e.g., 5-fluorouracil); 8 weeks
    • Retinoids; 90 days
    • Over-the-counter (OTC) wart therapies and cantharidin; 28 days
  8. Subject currently has or has had any of the following within the specified period prior to Visit 1 on or in the proximity to any of the common warts identified for treatment that, in the investigator's opinion, interferes with the study medication treatment or the study assessments:

    • Cutaneous malignancy; 180 days
    • Sunburn; currently
    • Pre-malignancy (e.g., actinic keratosis); currently
  9. Subject has a history of sensitivity to any of the ingredients in the study medications.
  10. Subject has any current skin or systemic disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations.
  11. Participation in another therapeutic investigational drug/device trial in which administration of an investigational treatment occurred with 30 days prior to Visit 1.
  12. Subject has an active malignancy.
  13. Subjects is viewed by the Principal Investigator as not being able to complete the study.

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): NCT03687372


Locations
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United States, Alabama
Aclaris Investigational Site
Mobile, Alabama, United States, 36608
United States, Arkansas
Aclaris Investigational Site
Hot Springs, Arkansas, United States, 71913
United States, California
Aclaris Investigational Site
Fountain Valley, California, United States, 92708
Aclaris Investigational site
San Diego, California, United States, 92123
United States, Florida
Aclaris Investigational Site
Aventura, Florida, United States, 33180
Aclaris Investigational Site
Jacksonville, Florida, United States, 32256
Aclaris Investigational Site
Miami, Florida, United States, 33144
Aclaris Investigational Site
Ocala, Florida, United States, 34470
United States, Georgia
Aclaris Investigational Site
Newnan, Georgia, United States, 30263
United States, Indiana
Aclaris Investigational Site
Indianapolis, Indiana, United States, 46256
United States, Kentucky
Aclaris Investigational Site
Louisville, Kentucky, United States, 40241
United States, Massachusetts
Aclaris Investigational Site
Chestnut Hill, Massachusetts, United States, 02467
United States, Michigan
Aclaris Investigational Site
Warren, Michigan, United States, 48088
United States, Minnesota
Aclaris Investigational Site
Fridley, Minnesota, United States, 55432
United States, Nevada
Aclaris Investigational Site
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Aclaris Investigational Site
Verona, New Jersey, United States, 07044
United States, Pennsylvania
Aclaris Investigational Site
Broomall, Pennsylvania, United States, 19008
Aclaris Investigational Site
Fort Washington, Pennsylvania, United States, 19034
United States, South Carolina
Aclaris Investigational Site
Charleston, South Carolina, United States, 29407
Aclaris Investigational Site
Greenville, South Carolina, United States, 29607
United States, Texas
Aclaris Investigational Site
Austin, Texas, United States, 78759
Aclaris Investigational Site
Pflugerville, Texas, United States, 78660
Aclaris Investigational Site
San Antonio, Texas, United States, 78213
United States, Washington
Aclaris Investigational Site
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Aclaris Therapeutics, Inc.

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Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03687372    
Other Study ID Numbers: A-101-WART-301
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aclaris Therapeutics, Inc.:
common warts
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
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents