Seborrheic Keratosis
Conditions
Brief summary
This study is an open-label study designed to evaluate subject's satisfaction after treatment of seborrheic keratoses with A-101 40%.
Interventions
A-101 Topical Solution applied Day 1, Day 15 and Day 29
Sponsors
Aclaris Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject can comprehend and is willing to sign an informed consent for participation in this study. 2. Male or female between the ages of 30 and 75 years old. 3. Subject has 3 eligible Seborrheic Keratoses; 2 target SKs must be on the face, and the additional 1 target SK must be on the neck or decolletage. 4. Subjects must have had cryosurgery for SK removal within the last 6 months and prior to first treatment with A-101 Topical Solution. 5. Target and non-target SKs must not have been previously treated. 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 the evaluation of any target or non-target SK or which exposes the subject to an unacceptable risk by study participation
Exclusion criteria
1. Subject has clinically atypical and /or rapidly growing Seborrheic Keratoses. 2. Subject has current systemic malignancy. 3. Subject would require the use of any topical treatment (e.g., moisturizers, sunscreens) to any of the target or non-target SKs 12 hours prior to any study visit. 4. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | Day 113 | Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Treatment | Day 113 | Effectiveness of treatment as measured by the Physician Lesion Assessment scale. The Physician Lesion Assessment Scale (PLA) is a 4 point scale used by the investigator to assess each subjects SK lesion. PLA=0 (Clear);PLA=1 (Near Clear; not elevated); PLA=2 (Thin;thickness \</= 1 mm); PLA=3 (Thick; thickness \> 1 mm). |
| Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction | Day 113 | Effectiveness of treatment assessed by PLA (4-point scale) compared to subject reported satisfaction with treatment. The PLA scale is a 4 point scale used by the investigator to assess each subject's SK lesion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A-101 Topical Solution Open Label Arm
A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29 | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | A-101 Topical Solution |
|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 6.97 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 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 | 41 Participants |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 41 |
| other Total, other adverse events | 8 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
Primary
Subject Satisfaction
Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution
Time frame: Day 113
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A-101 Topical Solution | Subject Satisfaction | very satisfied (5) | 21 Participants |
| A-101 Topical Solution | Subject Satisfaction | satsified (4) | 14 Participants |
| A-101 Topical Solution | Subject Satisfaction | moderately satisfied (3) | 4 Participants |
| A-101 Topical Solution | Subject Satisfaction | slightly satisfied (2) | 0 Participants |
| A-101 Topical Solution | Subject Satisfaction | not satisfied at all (1) | 2 Participants |
Secondary
Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction
Effectiveness of treatment assessed by PLA (4-point scale) compared to subject reported satisfaction with treatment. The PLA scale is a 4 point scale used by the investigator to assess each subject's SK lesion.
Time frame: Day 113
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A-101 Topical Solution | Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction | .318 point bi-serial correlation coefficient |
Secondary
Effectiveness of Treatment
Effectiveness of treatment as measured by the Physician Lesion Assessment scale. The Physician Lesion Assessment Scale (PLA) is a 4 point scale used by the investigator to assess each subjects SK lesion. PLA=0 (Clear);PLA=1 (Near Clear; not elevated); PLA=2 (Thin;thickness \</= 1 mm); PLA=3 (Thick; thickness \> 1 mm).
Time frame: Day 113
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-101 Topical Solution | Effectiveness of Treatment | -2.0 score on a scale (PLA) | Standard Deviation 0.62 |