Trial Outcomes & Findings for An Open-Label Safety Study of A-101 Solution (NCT NCT02667288)
NCT ID: NCT02667288
Last Updated: 2018-02-07
Results Overview
Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment (PWA) Scale. The PWA scale is a 4 point scale used by the investigator to assess each subject target SK Lesion.
COMPLETED
PHASE3
147 participants
Study day 148
2018-02-07
Participant Flow
Participant milestones
| Measure |
A-101 Solution
A-101 Solution 40% administered topically for a maximum of 4 treatment visits
A-101 Solution
|
|---|---|
|
Overall Study
STARTED
|
147
|
|
Overall Study
COMPLETED
|
134
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
A-101 Solution
A-101 Solution 40% administered topically for a maximum of 4 treatment visits
A-101 Solution
|
|---|---|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
An Open-Label Safety Study of A-101 Solution
Baseline characteristics by cohort
| Measure |
A-101 Solution
n=147 Participants
A-101 Solution 40% administered topically for a maximum of 4 treatment visits
A-101 Solution
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
101 Participants
n=5 Participants
|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 9.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
133 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 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
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
138 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
147 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study day 148Population: ITT Population
Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment (PWA) Scale. The PWA scale is a 4 point scale used by the investigator to assess each subject target SK Lesion.
Outcome measures
| Measure |
A-101 Solution
n=147 Participants
A-101 Solution 40% administered topically for a maximum of 4 treatment visits
A-101 Solution
|
|---|---|
|
Proportion of Subjects With Lesion Clearance
|
16 Participants
|
SECONDARY outcome
Timeframe: Day 148Population: Per Protocol Population
Physician Lesion Assessment (PWA) average Per-Subject Percent of target lesions judged to be clear at Visit 12 in the per protocol population. The PWA 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=142 Participants
A-101 Solution 40% administered topically for a maximum of 4 treatment visits
A-101 Solution
|
|---|---|
|
Per Subject Percent of Lesion Clearance
|
28.17 percentage of lesions cleared
Standard Deviation 35.34
|
Adverse Events
A-101 Solution
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A-101 Solution
n=147 participants at risk
A-101 Solution 40% administered topically for a maximum of 4 treatment visits
A-101 Solution
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
3/147 • Number of events 3
|
|
Immune system disorders
Seasonal Allergy
|
2.0%
3/147 • Number of events 3
|
|
Infections and infestations
Sinusitis
|
2.0%
3/147 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
1.4%
2/147 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
2/147 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
1.4%
2/147 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
2/147 • Number of events 2
|
Additional Information
Judy Schnyder, Sr. Director Clinical Operations
Aclaris Therapeutics
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