Seborrheic Keratosis
Conditions
Keywords
seborrheic keratosis
Brief summary
This is a randomized, double-blind, vehicle-controlled, parallel group study of A-101 Solution 40% compared with Vehicle Solution.
Detailed description
This is a randomized, double-blind, vehicle-controlled, parallel group study. During this study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face. The Target Lesions will be treated, by an investigational staff member other than the evaluating investigator, a maximum of two times.
Interventions
DRUGA-101 Solution
Active Drug
OTHERVehicle Solution
Placebo
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. Clinical diagnosis of stable clinically typical seborrheic keratosis 3. Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk, extremities and face that each are eligible for treatment as defined below: * Have a clinically typical appearance * Have a PLA of 2 or greater and be a discrete lesion * Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations * Not be in an intertriginous fold * Not be on the eyelids * Not be within 5mm of the orbital rim * Not be pedunculated 4. If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an active method of birth control for the duration of the study 5. Subject is non-pregnant and non-lactating 6. Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of any Target Lesion or which exposes the subject to an unacceptable risk by study participation 7. Subject is willing and able to follow all study instructions and to attend all study visits 8. Subject is able to comprehend and willing to sign an Informed Consent Form.
Exclusion criteria
1. Subject has clinically atypical and - or rapidly growing seborrheic keratosis lesions 2. Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Lesser -Trelat) 3. Subject has a current systemic malignancy 4. Subject has used any of the following systemic therapies within the specified period prior to enrollment: * Retinoids; 180 days * Glucocortico-steroids; * Anti-metabolites (e.g., methotrexate); 5. Subject has used any of the following topical therapies within the specified period or in a proximity to any Target Lesion, that in the investigator's opinion interferes with the study medication treatment or the study assessments: * LASER, light or other energy based therapy (e.g., intense pulsed light, photo-dynamic therapy; * Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-flurouracil, or ingenol mebutate; * Retinoids; * Microdermabrasion or superficial chemical peels; * Glucocortico-steroids or antibiotics 6. Subject currently has or has had any of the following within the specified period or in a proximity to any Target Lesion that, in the investigator's opinion, interferes with the study medication treatment or the study assessments: * A cutaneous malignancy; * A sunburn; currently * A pre-malignancy (e.g., actinic keratosis); currently * Body art (e.g., tattoos, piercing, etc.); currently * Excessive tan; currently 7. Subject has a history of sensitivity to any of the ingredients in the study medications 8. Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), 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 9. 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 |
|---|---|---|
| Proportion of Subjects With Target Lesion Clearance as Assessed by the Physician Lesion Assessment | Day 106 of the study | Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The PLA Scale is a 4 point scale used by the investigator to assess each subject's target SK Lesion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With 3 of 4 Target Lesion Clearance | Day 106 of the study | Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment (PLA=0) at Visit 8 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A-101 Solution A-101 Solution 40% applied topically
A-101 Solution: Active Drug | 223 |
| Vehicle Solution Vehicle Solution applied topically
Vehicle Solution: Placebo | 227 |
| Total | 450 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | A-101 Solution | Vehicle Solution | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 151 Participants | 172 Participants | 323 Participants |
| Age, Categorical Between 18 and 65 years | 72 Participants | 55 Participants | 127 Participants |
| Age, Continuous | 68.3 years STANDARD_DEVIATION 8.42 | 69.1 years STANDARD_DEVIATION 8.71 | 68.7 years STANDARD_DEVIATION 8.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 214 Participants | 216 Participants | 430 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 219 Participants | 221 Participants | 440 Participants |
| Region of Enrollment United States | 223 participants | 227 participants | 450 participants |
| Sex: Female, Male Female | 138 Participants | 126 Participants | 264 Participants |
| Sex: Female, Male Male | 85 Participants | 101 Participants | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 223 | 0 / 227 |
| other Total, other adverse events | 10 / 223 | 14 / 227 |
| serious Total, serious adverse events | 4 / 223 | 6 / 227 |
Outcome results
Primary
Proportion of Subjects With Target Lesion Clearance as Assessed by the Physician Lesion Assessment
Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The PLA Scale is a 4 point scale used by the investigator to assess each subject's target SK Lesion.
Time frame: Day 106 of the study
Population: ITT Population; all randomized subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A-101 Solution | Proportion of Subjects With Target Lesion Clearance as Assessed by the Physician Lesion Assessment | 9 Participants |
| Vehicle Solution | Proportion of Subjects With Target Lesion Clearance as Assessed by the Physician Lesion Assessment | 0 Participants |
Secondary
Proportion of Subjects With 3 of 4 Target Lesion Clearance
Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment (PLA=0) at Visit 8
Time frame: Day 106 of the study
Population: ITT population; all randomized subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A-101 Solution | Proportion of Subjects With 3 of 4 Target Lesion Clearance | 30 Participants |
| Vehicle Solution | Proportion of Subjects With 3 of 4 Target Lesion Clearance | 0 Participants |