Common Warts
Conditions
Brief summary
This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups.
Detailed description
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.
Interventions
Sponsors
Aclaris Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is at least 18 years of age 2. Subject has a clinical diagnosis of common warts 3. Subject has 1 appropriate Target Wart as defined below, on the trunk or extremities: * Have a longest axis that is 3mm to 10mm * Have a thickness ≤3mm * Be a discrete lesion * Be, when centered in the circular cutout of the provided template, the only common wart present * Not be periungual, subungual, genital or anal * Not be covered with hair which, in the Investigator's opinion, would interfere with the study medication treatments or the study evaluations Not be in an area that may be occluded (by clothing, footwear or within a skin fold). 4. The Target Wart has a Physician Wart Assessment (PWA) ≥2 5. 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 6. Subject is non-pregnant and non-lactating 7. 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 8. Subject is willing and able to follow all study instructions and to attend all study visits 9. Subject is able to comprehend and willing to sign an Informed Consent Form.
Exclusion criteria
1. Subject has clinically atypical warts on the trunk or extremities 2. Subject is immune compromised (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 1 year prior to enrollment 5. Subject has used any of the following intralesional therapies within the specified period prior to enrollment to the Target Wart: * Immunotherapy (Candida antigen, mumps antigen, Trichophyton antigen); * Anti-metabolite therapy (bleomycin, 5-fluorouracil) 6. Subject has used any of the following systemic therapies within the specified period prior to enrollment: * Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept, infliximab); * Glucocortico-steroids (inhaled and intra-nasal steroids are permitted); 7. 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 8. 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: * A cutaneous malignancy; * A pre-malignancy (actinic keratosis) 9. Subject has a history of sensitivity to any of the ingredients in the study medications 10. 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 11. Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Based on Mean Change in Physician Wart Assessment Over Time | 57 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13 | visit 10 to visit 13 | Percentage of subjects whose target wart was clear at Visit 10 and who remained clear at Visit 13 for active treatment groups |
| PWA Responder | Day 57 | The percentage of participants who were responders with the target wart judged to be clear (PWA = 0) at Visit 10. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A-101 Solution 40 A-101 Solution 40% administered once per week
A-101 Solution 40 | 33 |
| A-101 Solution 45 A-101 Solution 45% administered once per week
A-101 Solution 45 | 34 |
| Vehicle Solution Vehicle Solution administered once per week
Vehicle Solution | 31 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 | 1 |
| Overall Study | moved | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 3 |
Baseline characteristics
| Characteristic | A-101 Solution 40 | Total | Vehicle Solution | A-101 Solution 45 |
|---|---|---|---|---|
| Age, Continuous | 41.3 years STANDARD_DEVIATION 16.4 | 40.7 years STANDARD_DEVIATION 14.57 | 39.5 years STANDARD_DEVIATION 13.37 | 41.2 years STANDARD_DEVIATION 14.11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 11 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 81 Participants | 26 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 8 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 89 Participants | 27 Participants | 32 Participants |
| Region of Enrollment United States | 33 participants | 98 participants | 31 participants | 34 participants |
| Sex: Female, Male Female | 14 Participants | 52 Participants | 17 Participants | 21 Participants |
| Sex: Female, Male Male | 19 Participants | 46 Participants | 14 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 34 | 0 / 31 |
| other Total, other adverse events | 8 / 33 | 6 / 34 | 10 / 31 |
| serious Total, serious adverse events | 0 / 33 | 0 / 34 | 0 / 31 |
Outcome results
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.
Time frame: 57 Days
Population: Number of participants analyzed is the number of participants completing the protocol through visit 10.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-101 Solution 40 | Efficacy Based on Mean Change in Physician Wart Assessment Over Time | -0.38 units on a scale | Standard Deviation 0.75 |
| A-101 Solution 45 | Efficacy Based on Mean Change in Physician Wart Assessment Over Time | -1.00 units on a scale | Standard Deviation 0.97 |
| Vehicle Solution | Efficacy Based on Mean Change in Physician Wart Assessment Over Time | -0.44 units on a scale | Standard Deviation 0.85 |
Comparison: In this table Study Day 01 / Visit 2 has been considered as Baseline visit for calculating mean and mean change.~PVal\*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate.p-value: 0.555ANCOVA
Comparison: In this table Study Day 01 / Visit 2 has been considered as Baseline visit for calculating mean and mean change.~PVal\*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate.p-value: 0.009ANCOVA
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
Time frame: visit 10 to visit 13
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A-101 Solution 40 | Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13 | 100 percentage participants |
| A-101 Solution 45 | Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13 | 87.50 percentage participants |
Secondary
PWA Responder
The percentage of participants who were responders with the target wart judged to be clear (PWA = 0) at Visit 10.
Time frame: Day 57
Population: PP population = participants completing protocol to visit 10
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A-101 Solution 40 | PWA Responder | 3.13 percentage of responders |
| A-101 Solution 45 | PWA Responder | 25.81 percentage of responders |
| Vehicle Solution | PWA Responder | 3.70 percentage of responders |
Comparison: PVal\*- Chi-Square test used for calculating P-value by comparing Vehicle against each Active treatment groupp-value: 0.9313Chi-squared
p-value: 0.0236Chi-squared