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Trial record 1 of 24 for:    Aclaris [Lead]
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Safety 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: NCT03812510
Recruitment Status : Active, not recruiting
First Posted : January 23, 2019
Last Update Posted : January 7, 2020
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 Phase 3

Detailed Description:
A Phase 3 Open Label Safety Study of A-101 Topical Solution for the Treatment of Common Warts

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 424 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Open Label Safety Study of A-101 Topical Solution for the Treatment of Common Warts
Actual Study Start Date : February 7, 2019
Actual Primary Completion Date : November 27, 2019
Estimated Study Completion Date : January 15, 2020

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%




Primary Outcome Measures :
  1. Proportion of subjects with Treatment Emergent AEs after application of A-101 45% for the treatment of common warts [ Time Frame: Day 182 ]
    Safety exposure will be measured by the proportion of subjects with treatment emergent adverse events.


Secondary Outcome Measures :
  1. Efficacy of A-101 45% in the treatment of recurrent and/or new warts will be assessed using the Physician Wart Assessment (PWA) scale. [ Time Frame: Day 182 ]
    The Physician Wart Assessment scale (PWA) rates a subjects wart as grade 0=clear thru grade 3= not clear

  2. Duration of response of A-101 45% [ Time Frame: Day 182 ]
    Proportion of subjects that have a PWA =0 at V10 that continue to have a PWA=0 at V13.

  3. Onset of action of A-101 45% [ Time Frame: Day 182 ]
    Median time to achieve onset of Clearance (PWA=0) for all treated warts



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject or legal guardian is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
  • Subject must have completed study participation in either A-101-WART-301 or A-101-WART-302.
  • Male or female ≥ 1 years old.
  • Subject has a clinical diagnosis of common warts (verruca vulgaris).
  • Identified warts must have a longest axis of ≤8 mm

Exclusion Criteria:

  • Subject has clinically atypical warts.
  • Subject is immunocompromised
  • Subject has a history of Human Immunodeficiency Virus (HIV) infection.
  • Subject has had any Human Papilloma Virus (HPV) vaccine within 6 months prior to Visit 1.
  • Subject has used any of the following intralesional therapies within the specified period prior to Visit 1:

    1. Immunotherapy (e.g., Candida antigen, mumps antigen, Trichophyton antigen); 8 weeks
    2. Anti-metabolite therapy (e.g., bleomycin, 5-fluorouracil); 8 weeks
  • Subject has used any of the following systemic therapies within the specified period prior to Visit 1:

    1. Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept, infliximab); 16 weeks
    2. Glucocorticosteroids (inhaled and intra-nasal steroids are permitted); 28 days
  • Subject has used any of the following topical therapies 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:

    1. LASER, light or other energy-based therapy (e.g., intense pulsed light [IPL], photodynamic therapy [PDT]); 180 days
    2. Immunotherapy (e.g., imiquimod, squaric acid dibutyl ester [SADBE], etc.) 12 weeks
    3. Liquid nitrogen, electrodesiccation, curettage; 60 days
    4. Hydrogen peroxide; 90 days (other than IP from the 301/302 study)
    5. Antimetabolite therapy (e.g., 5-fluorouracil); 8 weeks
    6. Retinoids; 90 days
    7. Over-the-counter (OTC) wart therapies and cantharidin; 28 days
  • Subject currently has or has had any of the following within the specified period prior to Visit 1 on or in a 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:

    1. Cutaneous malignancy; 180 days
    2. Sunburn; currently
    3. Pre-malignancy (e.g., actinic keratosis); currently
  • Subject has a history of sensitivity to any of the ingredients in the study medications.
  • 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.
  • Participation in another therapeutic investigational drug/device trial (other than the Aclaris 301 or 302 study) in which administration of an investigational treatment occurred within 30 days prior to Visit 1.
  • Subject has an active malignancy.

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): NCT03812510


Locations
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Sponsors and Collaborators
Aclaris Therapeutics, Inc.
Investigators
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Study Director: David Gordon, MB, ChB Aclaris Therapeutics

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Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03812510    
Other Study ID Numbers: A-101-WART-303
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020

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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
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents