Trial Outcomes & Findings for A Randomized, Double-Blind, Vehicle-Controlled Study in Subjects With Seborrheic Keratosis (NCT NCT02667275)
NCT ID: NCT02667275
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 Physician Lesion Assessment Scale is a 4 point scale used by the investigator to assess the subject's target sk lesions.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
487 participants
Primary outcome timeframe
Study day 106
Results posted on
2018-02-06
Participant Flow
Participant milestones
| Measure |
A-101 Solution
A-101 Solution 40% administered once
A-101 Solution
|
Vehicle Solution
Vehicle Solution administered once
Vehicle Solution: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
244
|
243
|
|
Overall Study
COMPLETED
|
233
|
228
|
|
Overall Study
NOT COMPLETED
|
11
|
15
|
Reasons for withdrawal
| Measure |
A-101 Solution
A-101 Solution 40% administered once
A-101 Solution
|
Vehicle Solution
Vehicle Solution administered once
Vehicle Solution: Placebo
|
|---|---|---|
|
Overall Study
Protocol Violation
|
11
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
|
Overall Study
Discontinued early without completing
|
0
|
1
|
Baseline Characteristics
A Randomized, Double-Blind, Vehicle-Controlled Study in Subjects With Seborrheic Keratosis
Baseline characteristics by cohort
| Measure |
A-101 Solution
n=244 Participants
A-101 Solution 40% administered once
A-101 Solution
|
Vehicle Solution
n=243 Participants
Vehicle Solution administered once
Vehicle Solution: Placebo
|
Total
n=487 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
82 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
156 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
162 Participants
n=93 Participants
|
169 Participants
n=4 Participants
|
331 Participants
n=27 Participants
|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 8.92 • n=93 Participants
|
69.1 years
STANDARD_DEVIATION 8.64 • n=4 Participants
|
68.7 years
STANDARD_DEVIATION 8.78 • n=27 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=93 Participants
|
136 Participants
n=4 Participants
|
284 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=93 Participants
|
107 Participants
n=4 Participants
|
203 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
229 Participants
n=93 Participants
|
222 Participants
n=4 Participants
|
451 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
241 Participants
n=93 Participants
|
236 Participants
n=4 Participants
|
477 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
244 participants
n=93 Participants
|
243 participants
n=4 Participants
|
487 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Study day 106Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The Physician Lesion Assessment Scale is a 4 point scale used by the investigator to assess the subject's target sk lesions.
Outcome measures
| Measure |
A-101 Solution
n=244 Participants
A-101 Solution 40% administered once
A-101 Solution
|
Vehicle Solution
n=243 Participants
Vehicle Solution administered once
Vehicle Solution: Placebo
|
|---|---|---|
|
Proportion of Subjects With All Target Lesions Cleared According to Physician Lesion Assessment Scale
|
19 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Study day 106Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8
Outcome measures
| Measure |
A-101 Solution
n=244 Participants
A-101 Solution 40% administered once
A-101 Solution
|
Vehicle Solution
n=243 Participants
Vehicle Solution administered once
Vehicle Solution: Placebo
|
|---|---|---|
|
Percent of Lesions Cleared Scale
|
56 Participants
|
0 Participants
|
Adverse Events
A-101 Solution
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Vehicle Solution
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A-101 Solution
n=244 participants at risk
A-101 Solution 40% administered once
A-101 Solution
|
Vehicle Solution
n=243 participants at risk
Vehicle Solution administered once
Vehicle Solution: Placebo
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.41%
1/244 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.00%
0/243 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Cardiac disorders
Sinus Node Dysfunction
|
0.41%
1/244 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.00%
0/243 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
General disorders
Chest Pain
|
0.00%
0/244 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.41%
1/243 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Injury, poisoning and procedural complications
Pubis Fracture
|
0.41%
1/244 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.00%
0/243 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Injury, poisoning and procedural complications
Pulmonary Contusion
|
0.41%
1/244 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.00%
0/243 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.41%
1/244 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.00%
0/243 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.00%
0/244 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.41%
1/243 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Stage II
|
0.00%
0/244 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.41%
1/243 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Nervous system disorders
Dementia
|
0.41%
1/244 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.00%
0/243 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Nervous system disorders
Precerebral artery occlusion
|
0.41%
1/244 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.00%
0/243 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Psychiatric disorders
Anxiety
|
0.41%
1/244 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.00%
0/243 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Nervous system disorders
Post traumatic Stress Disorder
|
0.41%
1/244 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.00%
0/243 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.41%
1/244 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.00%
0/243 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Infections and infestations
Appendicitis
|
0.00%
0/244 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.41%
1/243 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
Other adverse events
| Measure |
A-101 Solution
n=244 participants at risk
A-101 Solution 40% administered once
A-101 Solution
|
Vehicle Solution
n=243 participants at risk
Vehicle Solution administered once
Vehicle Solution: Placebo
|
|---|---|---|
|
Infections and infestations
Sinusitis
|
1.6%
4/244 • Number of events 4 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
1.6%
4/243 • Number of events 4 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Infections and infestations
Nasopharyngitis
|
0.41%
1/244 • Number of events 1 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
1.2%
3/243 • Number of events 3 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
|
Infections and infestations
Herpes Zoster
|
1.2%
3/244 • Number of events 3 • Adverse events were collected from V2 (Day 1) through V8 (Day 106)
|
0.00%
0/243 • 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 the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER