Trial Outcomes & Findings for A Study of ATI-502 Topical Solution for the Treatment of Atopic Dermatitis (NCT NCT03585296)
NCT ID: NCT03585296
Last Updated: 2020-02-17
Results Overview
Treatment emergent adverse events (TEAEs)graded on a 3 point scale of mild, moderate or severe
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
8 weeks
Results posted on
2020-02-17
Participant Flow
Participant milestones
| Measure |
ATI-502
0.46% Solution applied twice a day for 28 days
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
ATI-502
0.46% Solution applied twice a day for 28 days
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Study of ATI-502 Topical Solution for the Treatment of Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
ATI-502
n=22 Participants
ATI-502 topical solution applied daily for four weeks.
ATI-502: Topical Solution
|
|---|---|
|
Age, Customized
< 35 years of age
|
11 Participants
n=99 Participants
|
|
Age, Customized
>/= 35 years of age
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 8 weeksTreatment emergent adverse events (TEAEs)graded on a 3 point scale of mild, moderate or severe
Outcome measures
| Measure |
ATI-502
n=22 Participants
ATI-502 topical solution applied daily for four weeks.
ATI-502: Topical Solution
|
|---|---|
|
Number of Subjects withTreatment-Emergent Adverse Events (Safety and Tolerability)
|
7 Participants
|
Adverse Events
ATI-502
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ATI-502
n=22 participants at risk
ATI-502 topical solution applied daily for four weeks.
ATI-502: Topical Solution
|
|---|---|
|
Infections and infestations
Cellulitis
|
4.5%
1/22 • Number of events 1 • 56 days
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including baseline or washout periods, even if no study treatment has been administered.
|
Other adverse events
| Measure |
ATI-502
n=22 participants at risk
ATI-502 topical solution applied daily for four weeks.
ATI-502: Topical Solution
|
|---|---|
|
Eye disorders
Chalazion
|
4.5%
1/22 • Number of events 1 • 56 days
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including baseline or washout periods, even if no study treatment has been administered.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
1/22 • Number of events 1 • 56 days
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including baseline or washout periods, even if no study treatment has been administered.
|
|
Infections and infestations
Conjunctivitis
|
4.5%
1/22 • Number of events 1 • 56 days
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including baseline or washout periods, even if no study treatment has been administered.
|
|
Gastrointestinal disorders
Gastroenteritis
|
4.5%
1/22 • Number of events 1 • 56 days
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including baseline or washout periods, even if no study treatment has been administered.
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
4.5%
1/22 • Number of events 1 • 56 days
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including baseline or washout periods, even if no study treatment has been administered.
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
1/22 • Number of events 1 • 56 days
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including baseline or washout periods, even if no study treatment has been administered.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.5%
1/22 • Number of events 1 • 56 days
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including baseline or washout periods, even if no study treatment has been administered.
|
|
Investigations
Alanine aminotransferase increased
|
4.5%
1/22 • Number of events 1 • 56 days
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including baseline or washout periods, even if no study treatment has been administered.
|
|
Investigations
Aspartate aminotransferase increased
|
4.5%
1/22 • Number of events 1 • 56 days
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including baseline or washout periods, even if no study treatment has been administered.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
4.5%
1/22 • Number of events 1 • 56 days
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including baseline or washout periods, even if no study treatment has been administered.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.5%
1/22 • Number of events 1 • 56 days
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including baseline or washout periods, even if no study treatment has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.5%
1/22 • Number of events 1 • 56 days
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including baseline or washout periods, even if no study treatment has been administered.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
4.5%
1/22 • Number of events 1 • 56 days
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including baseline or washout periods, even if no study treatment has been administered.
|
|
Vascular disorders
Hypertension
|
4.5%
1/22 • Number of events 1 • 56 days
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including baseline or washout periods, even if no study treatment has been administered.
|
Additional Information
Executive Director Clinical Operations
Aclaris Therapeutics
Phone: 4843242144
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place