Seborrheic Keratosis
Conditions
Brief summary
This is an open-label safety study. During this study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face.
Detailed description
This is an open-label safety 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 a maximum of 4 times.
Interventions
DRUGA-101 Solution
Sponsors
Aclaris Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 Lesion Clearance | Study day 148 | Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment (PWA) Scale. The PWA scale is a 4 point scale used by the investigator to assess each subject target SK Lesion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Per Subject Percent of Lesion Clearance | Day 148 | Physician Lesion Assessment (PWA) average Per-Subject Percent of target lesions judged to be clear at Visit 12 in the per protocol population. The PWA scale is a 4 point scale used by the investigator to assess the subject's Target SK lesions. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A-101 Solution A-101 Solution 40% administered topically for a maximum of 4 treatment visits
A-101 Solution | 147 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Protocol Violation | 5 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | A-101 Solution |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 101 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants |
| Age, Continuous | 68.4 years STANDARD_DEVIATION 9.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 133 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 138 Participants |
| Region of Enrollment United States | 147 participants |
| Sex: Female, Male Female | 100 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 147 |
| other Total, other adverse events | 14 / 147 |
| serious Total, serious adverse events | 0 / 147 |
Outcome results
Primary
Proportion of Subjects With Lesion Clearance
Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment (PWA) Scale. The PWA scale is a 4 point scale used by the investigator to assess each subject target SK Lesion.
Time frame: Study day 148
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A-101 Solution | Proportion of Subjects With Lesion Clearance | 16 Participants |
Secondary
Per Subject Percent of Lesion Clearance
Physician Lesion Assessment (PWA) average Per-Subject Percent of target lesions judged to be clear at Visit 12 in the per protocol population. The PWA scale is a 4 point scale used by the investigator to assess the subject's Target SK lesions.
Time frame: Day 148
Population: Per Protocol Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-101 Solution | Per Subject Percent of Lesion Clearance | 28.17 percentage of lesions cleared | Standard Deviation 35.34 |