Trial Outcomes & Findings for A Study of A-101 Solution 40% in Subjects With Seborrheic Keratosis. (NCT NCT02667236)
NCT ID: NCT02667236
Last Updated: 2018-02-06
Results Overview
Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The PLA Scale is a 4 point scale used by the investigator to assess each subject's target SK Lesion.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
450 participants
Primary outcome timeframe
Day 106 of the study
Results posted on
2018-02-06
Participant Flow
Participant milestones
| Measure |
A-101 Solution
A-101 Solution 40% applied topically
A-101 Solution: Active Drug
|
Vehicle Solution
Vehicle Solution applied topically
Vehicle Solution: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
223
|
227
|
|
Overall Study
COMPLETED
|
220
|
226
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
A-101 Solution
A-101 Solution 40% applied topically
A-101 Solution: Active Drug
|
Vehicle Solution
Vehicle Solution applied topically
Vehicle Solution: Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
A Study of A-101 Solution 40% in Subjects With Seborrheic Keratosis.
Baseline characteristics by cohort
| Measure |
A-101 Solution
n=223 Participants
A-101 Solution 40% applied topically
A-101 Solution: Active Drug
|
Vehicle Solution
n=227 Participants
Vehicle Solution applied topically
Vehicle Solution: Placebo
|
Total
n=450 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
72 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
151 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
323 Participants
n=5 Participants
|
|
Age, Continuous
|
68.3 years
STANDARD_DEVIATION 8.42 • n=5 Participants
|
69.1 years
STANDARD_DEVIATION 8.71 • n=7 Participants
|
68.7 years
STANDARD_DEVIATION 8.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
214 Participants
n=5 Participants
|
216 Participants
n=7 Participants
|
430 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
219 Participants
n=5 Participants
|
221 Participants
n=7 Participants
|
440 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
223 participants
n=5 Participants
|
227 participants
n=7 Participants
|
450 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 106 of the studyPopulation: ITT Population; all randomized subjects
Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The PLA Scale is a 4 point scale used by the investigator to assess each subject's target SK Lesion.
Outcome measures
| Measure |
A-101 Solution
n=223 Participants
A-101 Solution 40% applied topically
A-101 Solution: Active Drug
|
Vehicle Solution
n=227 Participants
Vehicle Solution applied topically
Vehicle Solution: Placebo
|
|---|---|---|
|
Proportion of Subjects With Target Lesion Clearance as Assessed by the Physician Lesion Assessment
|
9 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 106 of the studyPopulation: ITT population; all randomized subjects
Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment (PLA=0) at Visit 8
Outcome measures
| Measure |
A-101 Solution
n=223 Participants
A-101 Solution 40% applied topically
A-101 Solution: Active Drug
|
Vehicle Solution
n=227 Participants
Vehicle Solution applied topically
Vehicle Solution: Placebo
|
|---|---|---|
|
Proportion of Subjects With 3 of 4 Target Lesion Clearance
|
30 Participants
|
0 Participants
|
Adverse Events
A-101 Solution
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Vehicle Solution
Serious events: 6 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A-101 Solution
n=223 participants at risk
A-101 Solution 40% applied topically
A-101 Solution: Active Drug
|
Vehicle Solution
n=227 participants at risk
Vehicle Solution applied topically
Vehicle Solution: Placebo
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/223 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.44%
1/227 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/223 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.44%
1/227 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/223 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.88%
2/227 • Number of events 2 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.45%
1/223 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.00%
0/227 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.45%
1/223 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.00%
0/227 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Nervous system disorders
Central nervous system lesion
|
0.45%
1/223 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.00%
0/227 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/223 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.44%
1/227 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/223 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.44%
1/227 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.45%
1/223 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.00%
0/227 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Vascular disorders
Hypertension
|
0.00%
0/223 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.44%
1/227 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
Other adverse events
| Measure |
A-101 Solution
n=223 participants at risk
A-101 Solution 40% applied topically
A-101 Solution: Active Drug
|
Vehicle Solution
n=227 participants at risk
Vehicle Solution applied topically
Vehicle Solution: Placebo
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
1.3%
3/223 • Number of events 3 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
3.1%
7/227 • Number of events 7 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Infections and infestations
Bronchitis
|
1.3%
3/223 • Number of events 3 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.44%
1/227 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Infections and infestations
Upper Respiratory Infection
|
0.45%
1/223 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
1.3%
3/227 • Number of events 3 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
1.3%
3/223 • Number of events 3 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.00%
0/227 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/223 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
1.8%
4/227 • Number of events 4 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
Additional Information
Judy Schnyder, Sr. Director Clinical Operations
Aclaris Therapeutics
Phone: 484-329-2144
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Institution and Investigator agree not to publish the results of this study without the prior written consent of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER