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This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-101 Solution 40 | Experimental | A-101 Solution 40% administered once per week |
|
| A-101 Solution 45 | Experimental | A-101 Solution 45% administered once per week |
|
| Vehicle Solution | Placebo Comparator | Vehicle Solution administered once per week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A-101 Solution 40 | Drug |
| ||
| A-101 Solution 45 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Based on Mean Change in Physician Wart Assessment Over Time | 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. | 57 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13 | Percentage of subjects whose target wart was clear at Visit 10 and who remained clear at Visit 13 for active treatment groups | visit 10 to visit 13 |
| PWA Responder |
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Inclusion Criteria:
Subject is at least 18 years of age
Subject has a clinical diagnosis of common warts
Subject has 1 appropriate Target Wart as defined below, on the trunk or extremities:
The Target Wart has a Physician Wart Assessment (PWA) ≥2
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
Subject is non-pregnant and non-lactating
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
Subject is willing and able to follow all study instructions and to attend all study visits
Subject is able to comprehend and willing to sign an Informed Consent Form.
Exclusion Criteria:
Subject has clinically atypical warts on the trunk or extremities
Subject is immune compromised (due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
Subject has a history of Human Immunodeficiency Virus (HIV) infection
Subject has had any Human Papilloma Virus (HPV) vaccine within 1 year prior to enrollment
Subject has used any of the following intralesional therapies within the specified period prior to enrollment to the Target Wart:
Subject has used any of the following systemic therapies within the specified period prior to enrollment:
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
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:
Subject has a history of sensitivity to any of the ingredients in the study medications
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
Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Stuart D Shanler, MD | Aclaris Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aclaris Therapeutics, Inc. | Wayne | Pennsylvania | 19087 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | A-101 Solution 40 | A-101 Solution 40% administered once per week A-101 Solution 40 |
| FG001 | A-101 Solution 45 | A-101 Solution 45% administered once per week A-101 Solution 45 |
| FG002 | Vehicle Solution | Vehicle Solution administered once per week Vehicle Solution |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A-101 Solution 40 | A-101 Solution 40% administered once per week A-101 Solution 40 |
| BG001 | A-101 Solution 45 | A-101 Solution 45% administered once per week A-101 Solution 45 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy Based on Mean Change in Physician Wart Assessment Over Time | 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. | Number of participants analyzed is the number of participants completing the protocol through visit 10. | Posted | Mean | Standard Deviation | units on a scale | 57 Days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A-101 Solution 40 | A-101 Solution 40% administered once per week A-101 Solution 40 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | Systematic Assessment | Administration site conditions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judy Schnyder, Senior Director of Clinical Operations | Aclaris Therapeutics, Inc. | 484-329-2144 | jschnyder@aclaristx.com |
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| ID | Term |
|---|---|
| D014860 | Warts |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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|
| Vehicle Solution | Drug |
|
The percentage of participants who were responders with the target wart judged to be clear (PWA = 0) at Visit 10. |
| Day 57 |
| moved |
|
| Protocol Violation |
|
| BG002 | Vehicle Solution | Vehicle Solution administered once per week Vehicle Solution |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Percentages are based on the number of randomized subjects within each treatment group. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
A-101 Solution 45% administered once per week A-101 Solution 45 |
| OG002 | Vehicle Solution | Vehicle Solution administered once per week Vehicle Solution |
|
|
|
| Secondary | Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13 | Percentage of subjects whose target wart was clear at Visit 10 and who remained clear at Visit 13 for active treatment groups | Only the number of participants clear at visit 10 are compared to the number of participants clear at visit 13 to get the percentage clear for active treatment groups only. | Posted | Number | 95% Confidence Interval | percentage participants | visit 10 to visit 13 |
|
|
|
| Secondary | PWA Responder | The percentage of participants who were responders with the target wart judged to be clear (PWA = 0) at Visit 10. | PP population = participants completing protocol to visit 10 | Posted | Number | percentage of responders | Day 57 |
|
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 8 |
| 33 |
| EG001 | A-101 Solution 45 | A-101 Solution 45% administered once per week A-101 Solution 45 | 0 | 34 | 0 | 34 | 6 | 34 |
| EG002 | Vehicle Solution | Vehicle Solution administered once per week Vehicle Solution | 0 | 31 | 0 | 31 | 10 | 31 |
|
| Seasonal allergy | Immune system disorders | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
The Institution and Investigator agree not to publish the results of this study without the prior written consent of Sponsor.
| D017193 |
| Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| 0.0236 |
Not adjusted for multiple comparisons |
| Other |