Trial Outcomes & Findings for An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses (NCT NCT03487588)
NCT ID: NCT03487588
Last Updated: 2019-10-02
Results Overview
Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
Day 113
Results posted on
2019-10-02
Participant Flow
Participant milestones
| Measure |
A-101 Topical Solution
Open Label Arm
A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses
Baseline characteristics by cohort
| Measure |
A-101 Topical Solution
n=41 Participants
Open Label Arm
A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29
|
|---|---|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 6.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 113Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution
Outcome measures
| Measure |
A-101 Topical Solution
n=41 Participants
Open Label Arm
A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29
|
|---|---|
|
Subject Satisfaction
very satisfied (5)
|
21 Participants
|
|
Subject Satisfaction
satsified (4)
|
14 Participants
|
|
Subject Satisfaction
moderately satisfied (3)
|
4 Participants
|
|
Subject Satisfaction
slightly satisfied (2)
|
0 Participants
|
|
Subject Satisfaction
not satisfied at all (1)
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 113Effectiveness 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).
Outcome measures
| Measure |
A-101 Topical Solution
n=41 Participants
Open Label Arm
A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29
|
|---|---|
|
Effectiveness of Treatment
|
-2.0 score on a scale (PLA)
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Day 113Effectiveness 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.
Outcome measures
| Measure |
A-101 Topical Solution
n=41 Participants
Open Label Arm
A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29
|
|---|---|
|
Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction
|
.318 point bi-serial correlation coefficient
|
Adverse Events
A-101 Topical Solution
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A-101 Topical Solution
n=41 participants at risk
Open Label Arm
A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29
|
|---|---|
|
Eye disorders
Eyelid Oedema
|
4.9%
2/41 • Number of events 2 • 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).
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.
|
|
General disorders
Administration site discomfort
|
2.4%
1/41 • Number of events 1 • 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).
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.
|
|
General disorders
Administration site irritation
|
2.4%
1/41 • Number of events 1 • 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).
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
2.4%
1/41 • Number of events 1 • 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).
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/41 • Number of events 1 • 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).
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.
|
|
Investigations
Blood cholesterol increased
|
2.4%
1/41 • Number of events 1 • 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).
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.4%
1/41 • Number of events 1 • 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).
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.
|
|
Surgical and medical procedures
Tooth extraction
|
2.4%
1/41 • Number of events 1 • 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).
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.
|
Additional Information
Executive Director Clinical Operations
Aclaris Therapeutics
Phone: 4843247933
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60