A Study of A-101 Topical Solution for the Treatment of Common Warts
Sponsor:
Aclaris Therapeutics, Inc.
Collaborators:
Information provided by (Responsible Party):
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| Tracking Information | |||
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| First Submitted Date ICMJE | September 20, 2018 | ||
| First Posted Date ICMJE | October 2, 2018 | ||
| Last Update Posted Date | October 3, 2018 | ||
| Actual Study Start Date ICMJE | September 17, 2018 | ||
| Estimated Primary Completion Date | February 28, 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
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 ] The primary efficacy endpoint is the proportion of subjects whose identified common warts are determined to be clear on the PWA scale (PWA=0) at Visit 10 (Day 60). Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | A Study of A-101 Topical Solution for the Treatment of Common Warts |
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| Official Title ICMJE | 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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| Brief Summary | Phase 3 Study of A-101 Topical Solution in Subjects with Common Warts |
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| 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 ICMJE | Interventional | ||
| Study Phase | Phase 3 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study Masking: Interventional 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 |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Recruiting | ||
| Estimated Enrollment ICMJE |
500 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | May 30, 2019 | ||
| Estimated Primary Completion Date | February 28, 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | 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 common 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: 1. Immunotherapy (e.g., Candida antigen, mumps antigen, Trichophyton antigen); 8 weeks 2. 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: 1. Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept, infliximab); 16 weeks 2. 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: 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 5. Antimetabolite therapy (e.g., 5-fluorouracil); 8 weeks 6. Retinoids; 90 days 7. 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: 1. Cutaneous malignancy; 180 days 2. Sunburn; currently 3. 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. | ||
| Sex/Gender |
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| Ages | 2 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | ， | ||
| Study Sponsor ICMJE | Aclaris Therapeutics, Inc. | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | |||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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