Trial Outcomes & Findings for A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution (NCT NCT03495817)
NCT ID: NCT03495817
Last Updated: 2020-12-09
Results Overview
Target Area Hair Count will measure the hairs/cm2 on a subject's head. Higher values represent better outcomes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Baseline to 26 Weeks
Results posted on
2020-12-09
Participant Flow
Participant milestones
| Measure |
ATI-50002 Topical Solution
This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
|
|---|---|
|
26 Week Open Label
STARTED
|
31
|
|
26 Week Open Label
COMPLETED
|
23
|
|
26 Week Open Label
NOT COMPLETED
|
8
|
|
26 Week Extension
STARTED
|
19
|
|
26 Week Extension
COMPLETED
|
17
|
|
26 Week Extension
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
ATI-50002 Topical Solution
This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
|
|---|---|
|
26 Week Open Label
Adverse Event
|
3
|
|
26 Week Open Label
Withdrawal by Subject
|
4
|
|
26 Week Open Label
Lost to Follow-up
|
1
|
|
26 Week Extension
Lost to Follow-up
|
2
|
Baseline Characteristics
Ethnicity was only self-reported for those participants identifying as "White".
Baseline characteristics by cohort
| Measure |
ATI-50002 Topical Solution
n=31 Participants
This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
|
|---|---|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 6.49 • n=31 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=25 Participants • Ethnicity was only self-reported for those participants identifying as "White".
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=25 Participants • Ethnicity was only self-reported for those participants identifying as "White".
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=25 Participants • Ethnicity was only self-reported for those participants identifying as "White".
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=31 Participants
|
|
Height
|
173.7 centimeters
STANDARD_DEVIATION 9.04 • n=31 Participants
|
|
Weight
|
89.4 kilograms
STANDARD_DEVIATION 20.74 • n=31 Participants
|
|
Fitzpatrick Skin Type
I - Always Burns
|
3 Participants
n=31 Participants
|
|
Fitzpatrick Skin Type
II - Burns Easily
|
11 Participants
n=31 Participants
|
|
Fitzpatrick Skin Type
III - Burns Moderately
|
10 Participants
n=31 Participants
|
|
Fitzpatrick Skin Type
IV - Burns Minimally
|
4 Participants
n=31 Participants
|
|
Fitzpatrick Skin Type
V - Rarely Burns
|
2 Participants
n=31 Participants
|
|
Fitzpatrick Skin Type
VI - Never Burns
|
1 Participants
n=31 Participants
|
|
Sinclair Grade (Females)
Grade 1
|
0 Participants
n=10 Participants • Sinclair grading only applies to those participants that are Female.
|
|
Sinclair Grade (Females)
Grade 2
|
4 Participants
n=10 Participants • Sinclair grading only applies to those participants that are Female.
|
|
Sinclair Grade (Females)
Grade 3
|
4 Participants
n=10 Participants • Sinclair grading only applies to those participants that are Female.
|
|
Sinclair Grade (Females)
Grade 4
|
2 Participants
n=10 Participants • Sinclair grading only applies to those participants that are Female.
|
|
Sinclair Grade (Females)
Grade 5
|
0 Participants
n=10 Participants • Sinclair grading only applies to those participants that are Female.
|
|
Norwood-Hamilton Classification
Type I
|
0 Participants
n=21 Participants • Norwood-Hamilton Classification only applies to those participants that are Male.
|
|
Norwood-Hamilton Classification
Type II
|
0 Participants
n=21 Participants • Norwood-Hamilton Classification only applies to those participants that are Male.
|
|
Norwood-Hamilton Classification
Type III
|
7 Participants
n=21 Participants • Norwood-Hamilton Classification only applies to those participants that are Male.
|
|
Norwood-Hamilton Classification
Type IV
|
5 Participants
n=21 Participants • Norwood-Hamilton Classification only applies to those participants that are Male.
|
|
Norwood-Hamilton Classification
Type V
|
9 Participants
n=21 Participants • Norwood-Hamilton Classification only applies to those participants that are Male.
|
|
Norwood-Hamilton Classification
Type VI
|
0 Participants
n=21 Participants • Norwood-Hamilton Classification only applies to those participants that are Male.
|
|
Norwood-Hamilton Classification
Type VII
|
0 Participants
n=21 Participants • Norwood-Hamilton Classification only applies to those participants that are Male.
|
|
Prior Therapies for Androgenetic Alopecia
Device
|
2 Participants
n=31 Participants
|
|
Prior Therapies for Androgenetic Alopecia
Finasteride
|
2 Participants
n=31 Participants
|
|
Prior Therapies for Androgenetic Alopecia
Investigational Medication (Oral)
|
1 Participants
n=31 Participants
|
|
Prior Therapies for Androgenetic Alopecia
Investigational Medication (Topical)
|
1 Participants
n=31 Participants
|
|
Prior Therapies for Androgenetic Alopecia
Minoxidil
|
4 Participants
n=31 Participants
|
|
Prior Therapies for Androgenetic Alopecia
Other
|
7 Participants
n=31 Participants
|
|
Prior Therapies for Androgenetic Alopecia
No Prior Therapy
|
20 Participants
n=31 Participants
|
|
Time since Diagnosis of Androgenetic Alopecia
|
7.89 years
STANDARD_DEVIATION 5.098 • n=31 Participants
|
|
Age at Diagnosis of Androgenetic Alopecia
|
30.4 years
STANDARD_DEVIATION 8.05 • n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline to 26 WeeksPopulation: The variation in total number of patients reported across the various assessments is due to missing data.
Target Area Hair Count will measure the hairs/cm2 on a subject's head. Higher values represent better outcomes.
Outcome measures
| Measure |
ATI-50002 Topical Solution
n=20 Participants
This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
|
|---|---|
|
Mean Change From Baseline in Target Area Hair Count (TAHC)
|
8.6 hairs/cm^2
Standard Deviation 12.87
|
SECONDARY outcome
Timeframe: Baseline to 52 WeeksPopulation: The variation in total number of patients reported across the various assessments is due to missing data.
Target Area Hair Count will measure the hairs/cm2 on a subject's head. Higher values represent better outcomes.
Outcome measures
| Measure |
ATI-50002 Topical Solution
n=17 Participants
This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
|
|---|---|
|
Mean Change From Baseline in Target Area Hair Count (TAHC)
|
1.6 hairs/cm^2
Standard Deviation 18.92
|
SECONDARY outcome
Timeframe: Baseline to 26 WeeksPopulation: The variation in total number of patients reported across the various assessments is due to missing data.
Target Area Hair Width (TAHW) will measure the cumulative width of hair in the subject's target area. Higher values represent better outcomes.
Outcome measures
| Measure |
ATI-50002 Topical Solution
n=20 Participants
This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
|
|---|---|
|
Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW)
|
403.69 microns
Standard Deviation 817.271
|
SECONDARY outcome
Timeframe: Baseline to 52 WeeksPopulation: The variation in total number of patients reported across the various assessments is due to missing data.
Target Area Hair Width (TAHW) will measure the cumulative width of hair in the subject's target area. Higher values represent better outcomes.
Outcome measures
| Measure |
ATI-50002 Topical Solution
n=17 Participants
This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
|
|---|---|
|
Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW)
|
35.28 microns
Standard Deviation 901.082
|
SECONDARY outcome
Timeframe: Baseline to 26 WeeksPopulation: The variation in total number of patients reported across the various assessments is due to missing data.
Investigators will use a 7 point rating scale to assess hair growth following treatment with study medication. A score of +3 corresponds to significant hair growth and a score of -3 corresponds to lack of hair growth. Subjects with a score of +1 to +3 were considered to have slightly increased hair growth or better.
Outcome measures
| Measure |
ATI-50002 Topical Solution
n=22 Participants
This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
|
|---|---|
|
Investigator Global Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
|
16 Participants
|
SECONDARY outcome
Timeframe: Baseline to 52 WeeksPopulation: The variation in total number of patients reported across the various assessments is due to missing data.
Investigators will use a 7 point rating scale to assess hair growth following treatment with study medication. A score of +3 corresponds to significant hair growth and a score of -3 corresponds to lack of hair growth. Subjects with a score of +1 to +3 were considered to have slightly increased hair growth or better.
Outcome measures
| Measure |
ATI-50002 Topical Solution
n=12 Participants
This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
|
|---|---|
|
Investigator Global Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline to 26 WeeksPopulation: The variation in total number of patients reported across the various assessments is due to missing data.
Subjects will use a 7 point rating scale to assess hair growth following treatment with study medication. A score of +3 corresponds to significant hair growth and a score of -3 corresponds to lack of hair growth. Subjects with a score of +1 to +3 were considered to have slightly increased hair growth or better.
Outcome measures
| Measure |
ATI-50002 Topical Solution
n=22 Participants
This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
|
|---|---|
|
Subject Self-Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
|
18 Participants
|
SECONDARY outcome
Timeframe: Baseline to 52 WeeksPopulation: The variation in total number of patients reported across the various assessments is due to missing data.
Subjects will use a 7 point rating scale to assess hair growth following treatment with study medication. A score of +3 corresponds to significant hair growth and a score of -3 corresponds to lack of hair growth. Subjects with a score of +1 to +3 were considered to have slightly increased hair growth or better.
Outcome measures
| Measure |
ATI-50002 Topical Solution
n=17 Participants
This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
|
|---|---|
|
Subject Self-Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline to 26 WeeksPopulation: This measurement only applies to men participating in the study.
Measure Description: Subject's level of hair loss at baseline based on the Norwood Hamilton Scale for male subjects. Type I: Minimal or no recession of the hairline Type II: Triangular areas of recession at the frontotemporal hairline Type III: Deep symmetrical recession at the temples are bare or only sparsely covered by hair Type IV: Frontotemporal recession is more severe than in Type III with sparse or no hair on the vertex Type V: The vertex hair loss region is separated from the frontotemporal region but is less distinct Type VI: Sparse hair remaining Type VII: The most severe form of hair loss. Lower scores represent better outcomes.
Outcome measures
| Measure |
ATI-50002 Topical Solution
n=15 Participants
This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
|
|---|---|
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
Improvement from Type V to Type III Vertex
|
2 Participants
|
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
Improvement from Type V to Type IV
|
1 Participants
|
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
Improvement from Type IV to Type III Vertex
|
1 Participants
|
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
Improvement from Type III to Type III Vertex
|
2 Participants
|
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
No Improvement Measured
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline to 52 WeeksPopulation: This measurement only applies to men participating in the study. Variances from participant low section are the result of missing data.
Measure Description: Subject's level of hair loss at baseline based on the Norwood Hamilton Scale for male subjects. Type I: Minimal or no recession of the hairline Type II: Triangular areas of recession at the frontotemporal hairline Type III: Deep symmetrical recession at the temples are bare or only sparsely covered by hair Type IV: Frontotemporal recession is more severe than in Type III with sparse or no hair on the vertex Type V: The vertex hair loss region is separated from the frontotemporal region but is less distinct Type VI: Sparse hair remaining Type VII: The most severe form of hair loss. Lower scores represent better outcomes.
Outcome measures
| Measure |
ATI-50002 Topical Solution
n=14 Participants
This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
|
|---|---|
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
Improvement from Type V to Type III Vertex
|
1 Participants
|
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
Improvement from Type III Vertex to Type II
|
1 Participants
|
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
Improvement from Type V to Type IV
|
1 Participants
|
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
Improvement from Type IV to Type III Vertex
|
1 Participants
|
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
Improvement from Type III Vertex to Type III
|
1 Participants
|
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
No Improvement
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline to 26 WeeksPopulation: This measurement only applies to women participating in the study. Variances from participant low section are the result of missing data.
Treating investigators will be required to rate the subject's level of hair loss at baseline based on the Sinclair scale for women. Grade 1: is normal. This pattern is found in all girls prior to puberty but in only forty-five percent of women aged eighty or over. Grade 2: shows a widening of the central part. Grade 3: shows a widening of the central part and thinning of the hair on either side of the central part. Grade 4: reveals the emergence of a diffuse hair loss over the top of the scalp. Grade 5: indicates advanced hair loss. Lower grades represent better outcomes.
Outcome measures
| Measure |
ATI-50002 Topical Solution
n=7 Participants
This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
|
|---|---|
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale
Improvement from Grade 4 to Grade 3
|
1 Participants
|
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale
Improvement from Grade 2 to Grade 1
|
1 Participants
|
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale
No Measured Improvement
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline to 52 WeeksPopulation: This measurement only applies to women participating in the study. Variances from participant low section are the result of missing data.
Treating investigators will be required to rate the subject's level of hair loss at baseline based on the Sinclair scale for women. Grade 1: is normal. This pattern is found in all girls prior to puberty but in only forty-five percent of women aged eighty or over. Grade 2: shows a widening of the central part. Grade 3: shows a widening of the central part and thinning of the hair on either side of the central part. Grade 4: reveals the emergence of a diffuse hair loss over the top of the scalp. Grade 5: indicates advanced hair loss. Lower grades represent better outcomes.
Outcome measures
| Measure |
ATI-50002 Topical Solution
n=3 Participants
This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
|
|---|---|
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale
Improvement from Grade 4 to Grade 3
|
1 Participants
|
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale
Improvement from Grade 3 to Grade 2
|
1 Participants
|
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale
No Improvement
|
1 Participants
|
Adverse Events
ATI-50002 Topical Solution
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ATI-50002 Topical Solution
n=31 participants at risk
This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
Other adverse events
| Measure |
ATI-50002 Topical Solution
n=31 participants at risk
This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
6.5%
2/31 • Number of events 2 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Eye disorders
Photopsia
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Gastrointestinal disorders
Constipation
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
General disorders
Chest pain
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Infections and infestations
Folliculitis
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Infections and infestations
Influenza
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Infections and infestations
Herpes zoster
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Infections and infestations
Nasal herpes
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Infections and infestations
Otitis media
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Infections and infestations
Sinusitis
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Infections and infestations
Upper respiratory tract infection
|
6.5%
2/31 • Number of events 2 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Infections and infestations
Vulvovaginal candidiasis
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Investigations
Aspartate aminotransferase increased
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Investigations
Liver function test increased
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.5%
2/31 • Number of events 2 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Nervous system disorders
Amnesia
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Nervous system disorders
Neuralgia
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.5%
2/31 • Number of events 2 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
1/31 • Number of events 1 • Open Label = 26 weeks; Extension period = 26 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until 30 days following the last application of study medication. Events with onset dates more than 30 days after the last application of study medication were considered as "post-therapy."
|
Additional Information
Aclaris Clinical Operations
Aclaris Therapeutics, Inc.
Phone: 1-833-225-2747
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place