Common Wart
Conditions
Brief summary
The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.
Detailed description
The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week. The secondary objectives of this study are to evaluate the clinical effect of A-101 when applied to all treated Warts (Target Warts plus Non-Target Warts) twice a week, duration of response in all treated Warts (Target Warts plus Non-Target Warts), and safety of A-101.
Interventions
A-101 Topical Solution
A-101 Vehicle Solution
Sponsors
Aclaris Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study. * Male or female ≥ 8 years old. * Subject 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. * Woman of childbearing potential (WOCBP) must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active 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 impair the evaluation of any Target and Non-Target Warts or which exposes the subject to an unacceptable risk by study participation. * Subject is willing and able to follow all study instructions and to attend all study visits.
Exclusion criteria
* Subject has clinically atypical warts on the trunk or extremities. * Subject is immunocompromised (e.g., 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 Visit 1 * Subject has a history of sensitivity to any of the ingredients in the study medications. * Subject has any current skin 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 trial in which administration of an investigational study medication occurred with 30 days prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician's Wart Assessment | Day 57 | Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated. 1. Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length) 2. A visible wart ≥ 3 mm and \< 6 mm in maximal diameter (or length) 3. A visible wart ≥ 6 mm in maximal diameter (or length) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active A-101 Topical Solution
A-101 Topical Solution: A-101 Topical Solution | 81 |
| Vehicle Vehicle
A-101 Vehicle Solution: A-101 Vehicle Solution | 78 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Active | Total | Vehicle |
|---|---|---|---|
| Age, Continuous | 37.96 years STANDARD_DEVIATION 18.09 | 39.73 years STANDARD_DEVIATION 17.8 | 41.56 years STANDARD_DEVIATION 17.42 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 29 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants | 120 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 10 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 78 Participants | 148 Participants | 70 Participants |
| Region of Enrollment United States | 81 participants | 159 participants | 78 participants |
| Sex: Female, Male Female | 48 Participants | 91 Participants | 43 Participants |
| Sex: Female, Male Male | 33 Participants | 68 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 78 |
| other Total, other adverse events | 28 / 81 | 19 / 78 |
| serious Total, serious adverse events | 0 / 81 | 0 / 78 |
Outcome results
Primary
Physician's Wart Assessment
Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated. 1. Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length) 2. A visible wart ≥ 3 mm and \< 6 mm in maximal diameter (or length) 3. A visible wart ≥ 6 mm in maximal diameter (or length)
Time frame: Day 57
Population: Per-Protocol (PP)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Physician's Wart Assessment | 1.52 score on a scale | Standard Deviation 1.06 |
| Vehicle | Physician's Wart Assessment | 2.23 score on a scale | Standard Deviation 0.66 |