Seborrheic Keratosis (SK)
Conditions
Keywords
SK, Seborrheic Keratosis
Brief summary
Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on the back of subjects.
Detailed description
The main objective of this study is to evaluate the safety, effectiveness and tolerability of three concentrations of A-101 25%, 32.5%, and 40%, when applied to individual seborrheic keratosis target lesions on the back compared with a matching A-101 vehicle.
Interventions
DRUGA-101 25%
Low Dose Concentration of A-101 applied to one of 4 Target Lesions
DRUGA-101 32.5%
Mid Dose Concentration of A-101 applied to one of 4 Target Lesions
DRUGA-101 40%
High Dose Concentration A-101 applied to one of 4 Target Lesions
DRUGA-101 Vehicle
Placebo applied to one of 4 Target Lesions
Sponsors
Aclaris Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
The three tests solutions and the placebo solution are each applied topically to 1 of 4 target lesions on the backs of each subject (determined by the randomization schedule). If needed a second treatment may be applied at Visit 5.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Is at least 18 years of age 2. Has a clinical diagnosis of stable clinically typical seborrheic keratosis 3. Has at least 4 appropriate seborrheic keratosis target lesions on the back 4. If subject is a women of childbearing potential, she must have a negative urine pregnancy test and must agree to use an active form of birth control for the duration of the study 5. Is non-pregnant and non-lactating 6. Is in good general health and free of any 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. Is willing and able to follow all study instructions and to attend all study visits 8. Is able to comprehend and willing to sign an Informed Consent Form (ICF).
Exclusion criteria
1. Has clinically atypical and/or rapidly growing seborrheic keratosis lesions 2. Has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat) 3. Has used any of the following systemic therapies within the specified period prior to Visit 1: * Retinoids; 180 days * Glucocorticosteroids; 28 days * Anti-metabolites (e.g., methotrexate); 28 days 4. Has used any of the following topical therapies on the treatment area within the specified period prior to Visit 1: * Retinoids; 90 days * Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days * Glucocorticosteroids or antibiotics; 14 days * Moisturizers/emollients, sunscreens; 12 hours 5. Has had any LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)) or other energy based therapy on the treatment area within 180 days prior to Visit 1 6. Has a history of keloid formation or hypertrophic scarring 7. Has a current systemic malignancy 8. Has a history of, within the 180 days prior to Visit 1, or has a current cutaneous malignancy on the treatment area 9. Has a current pre-malignancy (e.g., actinic keratosis) on the treatment area 10. Has had body art (e.g., tattoos, piercing, sculpting, etc.) or any other invasive, non-therapeutic procedure performed on the treatment area that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations 11. Has excessive tan on the treatment area that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations 12. Has experienced a sunburn on the treatment area within the previous 4 weeks 13. Has a history of sensitivity to any of the ingredients in the study medications 14. Has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, tattoos, excessive hair, open wounds on the back) that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations 15. Has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Physician Lesion Assessment Scale | Visit 2 to visit 9 (78 days) | Mean Change in Score on the Physician Lesion Assessment Scale (PLA) of each Target Lesion. The PLAS is a four point scale from 0-3 with 0 being clear and 3 being the worst lesion. The primary effectiveness will consist of the mean change from Visit 2 to Visit 9 in PLA performed using Analysis of Covariance (ANCOVA) with Visit 2 PLAS as the covariate. Comparisons between vehicle and each active treatment group will be performed within the model using least-squares means and the common error term. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject's Self Assessment Scale | Visit 9 (Day 78) | Subjects self assessment of the condition of their lesions based on a scale of Clear (Grade 0), Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3). |
Countries
United States
Participant flow
Pre-assignment details
In this study each patient is treated with all 4 treatments on 4 different lesions on their back. Therefore, each patient participates in each group so the total enrollment matches the number of lesions treated but not the total participants.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Subjects were required to have 4 Target Seborrheic Keratosis Lesions their back. Each lesion was treated with one of the four treatment interventions (A-101 Solution 25%, A-101, Solution 32.5%, A-101 Solution 40% and the A-101 Solution Vehicle) in a randomized fashion. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| A- 101 25% | Withdrawal by Subject | 1 | 0 | 0 | 0 |
| A-101 32.5% | Withdrawal by Subject | 0 | 1 | 0 | 0 |
| A-101 40% | Withdrawal by Subject | 0 | 0 | 1 | 0 |
| Placebo | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 29 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 69.43 Years STANDARD_DEVIATION 6.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 0 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Region of Enrollment United States | 35 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 21 / 35 | 21 / 35 | 25 / 35 | 25 / 35 |
| serious Total, serious adverse events | 1 / 35 | 1 / 35 | 1 / 35 | 1 / 35 |
Outcome results
Primary
Mean Change in Physician Lesion Assessment Scale
Mean Change in Score on the Physician Lesion Assessment Scale (PLA) of each Target Lesion. The PLAS is a four point scale from 0-3 with 0 being clear and 3 being the worst lesion. The primary effectiveness will consist of the mean change from Visit 2 to Visit 9 in PLA performed using Analysis of Covariance (ANCOVA) with Visit 2 PLAS as the covariate. Comparisons between vehicle and each active treatment group will be performed within the model using least-squares means and the common error term.
Time frame: Visit 2 to visit 9 (78 days)
Population: A total of 35 subjects were enrolled with 34 subjects in the analysis population. Each target lesion on a subject was treated with one of the 4 study medications in a random fashion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-101 25% | Mean Change in Physician Lesion Assessment Scale | -0.47 Change in Score on a scale | Standard Deviation 0.66 |
| A-101 32.5% | Mean Change in Physician Lesion Assessment Scale | -0.88 Change in Score on a scale | Standard Deviation 0.73 |
| A-101 40% | Mean Change in Physician Lesion Assessment Scale | -1.12 Change in Score on a scale | Standard Deviation 0.81 |
| A-101 Vehicle | Mean Change in Physician Lesion Assessment Scale | -0.15 Change in Score on a scale | Standard Deviation 0.36 |
Secondary
Subject's Self Assessment Scale
Subjects self assessment of the condition of their lesions based on a scale of Clear (Grade 0), Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3).
Time frame: Visit 9 (Day 78)
Population: A total of 35 subjects were enrolled with 34 subjects in the analysis population. Each target lesion on a subject was treated with one of the 4 study medications in a random fashion.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A-101 25% | Subject's Self Assessment Scale | Clear | 7 Participants |
| A-101 25% | Subject's Self Assessment Scale | Mild | 12 Participants |
| A-101 25% | Subject's Self Assessment Scale | Moderate | 13 Participants |
| A-101 25% | Subject's Self Assessment Scale | Severe | 02 Participants |
| A-101 32.5% | Subject's Self Assessment Scale | Mild | 09 Participants |
| A-101 32.5% | Subject's Self Assessment Scale | Moderate | 12 Participants |
| A-101 32.5% | Subject's Self Assessment Scale | Severe | 04 Participants |
| A-101 32.5% | Subject's Self Assessment Scale | Clear | 09 Participants |
| A-101 40% | Subject's Self Assessment Scale | Moderate | 11 Participants |
| A-101 40% | Subject's Self Assessment Scale | Mild | 13 Participants |
| A-101 40% | Subject's Self Assessment Scale | Severe | 02 Participants |
| A-101 40% | Subject's Self Assessment Scale | Clear | 08 Participants |
| A-101 Vehicle | Subject's Self Assessment Scale | Severe | 02 Participants |
| A-101 Vehicle | Subject's Self Assessment Scale | Mild | 13 Participants |
| A-101 Vehicle | Subject's Self Assessment Scale | Clear | 01 Participants |
| A-101 Vehicle | Subject's Self Assessment Scale | Moderate | 18 Participants |