A Phase 4 interventional study of A-101 Topical Solution in Seborrheic Keratosis, sponsored by Aclaris Therapeutics, Inc.. Completed at 3 sites in United States. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-10-02.
Sponsored by Aclaris Therapeutics, Inc. · Phase 4, Interventional, and Treatment
This study is an open-label study designed to evaluate subject's satisfaction after treatment of seborrheic keratoses with A-101 40%.
Exclusion Criteria:
Open Label Arm
Drug: A-101 Topical Solution
A-101 Topical Solution applied Day 1, Day 15 and Day 29
Subject Satisfaction
Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution
Time frame: Day 113
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
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
| Milestone | A-101 Topical Solution |
|---|---|
| Started | 41 |
| Completed | 41 |
| Not completed | 0 |
Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution
| Participants | A-101 Topical Solution |
|---|---|
| very satisfied (5) | 21 |
| satsified (4) | 14 |
| moderately satisfied (3) | 4 |
| slightly satisfied (2) | 0 |
| not satisfied at all (1) | 2 |
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).
| score on a scale (PLA) | A-101 Topical Solution |
|---|---|
| Effectiveness of Treatment | -2.0 ± 0.62 |
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.
| point bi-serial correlation coefficient | A-101 Topical Solution |
|---|---|
| Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction | .318 |
Collected over 17 weeks; The reporting period for SAEs began when the subject signed the informed consent form. Non serious clinical AEs were collected following the application of the study drug at Visit 2 and continued through Visit 11. All safety reporting (AEs and SAEs) was concluded at Visit 11 (Day 113).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A-101 Topical Solution | 0/41 (0%) | 0/41 (0%) | 8/41 (19.5%) |
| Event | A-101 Topical Solution |
|---|---|
| Eyelid OedemaEye disorders | 2/41 |
| Administration site discomfortGeneral disorders | 1/41 |
| Administration site irritationGeneral disorders | 1/41 |
| Arthropod stingInjury, poisoning and procedural complications | 1/41 |
| FallInjury, poisoning and procedural complications | 1/41 |
| Blood cholesterol increasedInvestigations | 1/41 |
| Dermatitis contactSkin and subcutaneous tissue disorders | 1/41 |
| Tooth extractionSurgical and medical procedures | 1/41 |
| Age, Continuous(years) | A-101 Topical Solution |
|---|---|
| Mean | 62.4 ± 6.97 |
| Sex: Female, Male(Participants) | A-101 Topical Solution |
|---|---|
| Female | 24 |
| Male | 17 |
| Ethnicity (NIH/OMB)(Participants) | A-101 Topical Solution |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 41 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | A-101 Topical Solution |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 41 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | A-101 Topical Solution |
|---|---|
| United States | 41 |
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Aclaris Therapeutics, Inc.