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

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ClinicalTrials.gov Identifier: NCT03687372
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : September 27, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 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
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : May 30, 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



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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 ≥ 2 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. If any of the laboratory values are outside normal range, the treating investigator must assess the value(s) as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization.
  7. Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of the identified common warts or which exposes the subject to an unacceptable risk by study participation.
  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


Contacts
Contact: Judy Schynder 484-329-2144 jschnyder@aclaristx.com

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Sponsors and Collaborators
Aclaris Therapeutics, Inc.

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

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:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Pharmaceutical Solutions
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents