Androgenetic Alopecia
Conditions
Brief summary
Open label study to assess safety, tolerability, and efficacy of ATI-50002 in male and female subjects with androgenetic alopecia.
Detailed description
This is an open-label study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution in male and female subjects with androgenetic alopecia.
Interventions
DRUGATI-50002
ATI-50002 Topical Solution
Sponsors
Aclaris Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Male subjects and non-pregnant, non-nursing female subjects 18-50 years of age with a clinical diagnosis of androgenetic alopecia. Subjects willing to agree to have a small circle of hair clipped to approx. 1mm in length on their balding spot. Subjects willing to agree to have a permanent dot tattoo applied to their scalp to mark the center of the identified target area. Subjects must agree to maintain the same hair style and hair care regimen during the study.
Exclusion criteria
Females who are nursing, pregnant, or planning to become pregnant for the duration of the study and up to 30 days after the last application of study medication. Clinical diagnosis of alopecia areata or other non AGA forms of alopecia. Scalp hair loss on the treatment area, due to disease, injury or medical therapy. Active skin disease of the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments or efficacy or safety.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Target Area Hair Count (TAHC) | Baseline to 26 Weeks | Target Area Hair Count will measure the hairs/cm2 on a subject's head. Higher values represent better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW) | Baseline to 26 Weeks | Target Area Hair Width (TAHW) will measure the cumulative width of hair in the subject's target area. Higher values represent better outcomes. |
| Investigator Global Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale | Baseline to 26 Weeks | 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. |
| Mean Change From Baseline in Target Area Hair Count (TAHC) | Baseline to 52 Weeks | Target Area Hair Count will measure the hairs/cm2 on a subject's head. Higher values represent better outcomes. |
| Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale | Baseline to 26 Weeks | 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. |
| Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale | Baseline to 26 Weeks | 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. |
| Subject Self-Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale | Baseline to 26 Weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 26 Week Extension | Lost to Follow-up | 2 |
| 26 Week Open Label | Adverse Event | 3 |
| 26 Week Open Label | Lost to Follow-up | 1 |
| 26 Week Open Label | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | ATI-50002 Topical Solution |
|---|---|
| Age at Diagnosis of Androgenetic Alopecia | 30.4 years STANDARD_DEVIATION 8.05 |
| Age, Continuous | 38.2 years STANDARD_DEVIATION 6.49 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Fitzpatrick Skin Type I - Always Burns | 3 Participants |
| Fitzpatrick Skin Type II - Burns Easily | 11 Participants |
| Fitzpatrick Skin Type III - Burns Moderately | 10 Participants |
| Fitzpatrick Skin Type IV - Burns Minimally | 4 Participants |
| Fitzpatrick Skin Type VI - Never Burns | 1 Participants |
| Fitzpatrick Skin Type V - Rarely Burns | 2 Participants |
| Height | 173.7 centimeters STANDARD_DEVIATION 9.04 |
| Norwood-Hamilton Classification Type I | 0 Participants |
| Norwood-Hamilton Classification Type II | 0 Participants |
| Norwood-Hamilton Classification Type III | 7 Participants |
| Norwood-Hamilton Classification Type IV | 5 Participants |
| Norwood-Hamilton Classification Type V | 9 Participants |
| Norwood-Hamilton Classification Type VI | 0 Participants |
| Norwood-Hamilton Classification Type VII | 0 Participants |
| Prior Therapies for Androgenetic Alopecia Device | 2 Participants |
| Prior Therapies for Androgenetic Alopecia Finasteride | 2 Participants |
| Prior Therapies for Androgenetic Alopecia Investigational Medication (Oral) | 1 Participants |
| Prior Therapies for Androgenetic Alopecia Investigational Medication (Topical) | 1 Participants |
| Prior Therapies for Androgenetic Alopecia Minoxidil | 4 Participants |
| Prior Therapies for Androgenetic Alopecia No Prior Therapy | 20 Participants |
| Prior Therapies for Androgenetic Alopecia Other | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 21 Participants |
| Sinclair Grade (Females) Grade 1 | 0 Participants |
| Sinclair Grade (Females) Grade 2 | 4 Participants |
| Sinclair Grade (Females) Grade 3 | 4 Participants |
| Sinclair Grade (Females) Grade 4 | 2 Participants |
| Sinclair Grade (Females) Grade 5 | 0 Participants |
| Time since Diagnosis of Androgenetic Alopecia | 7.89 years STANDARD_DEVIATION 5.098 |
| Weight | 89.4 kilograms STANDARD_DEVIATION 20.74 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 18 / 31 |
| serious Total, serious adverse events | 1 / 31 |
Outcome results
Primary
Mean Change From Baseline in Target Area Hair Count (TAHC)
Target Area Hair Count will measure the hairs/cm2 on a subject's head. Higher values represent better outcomes.
Time frame: Baseline to 26 Weeks
Population: The variation in total number of patients reported across the various assessments is due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATI-50002 Topical Solution | Mean Change From Baseline in Target Area Hair Count (TAHC) | 8.6 hairs/cm^2 | Standard Deviation 12.87 |
Secondary
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
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.
Time frame: Baseline to 26 Weeks
Population: This measurement only applies to men participating in the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-50002 Topical Solution | Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale | Improvement from Type V to Type III Vertex | 2 Participants |
| ATI-50002 Topical Solution | Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale | Improvement from Type V to Type IV | 1 Participants |
| ATI-50002 Topical Solution | Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale | Improvement from Type IV to Type III Vertex | 1 Participants |
| ATI-50002 Topical Solution | Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale | Improvement from Type III to Type III Vertex | 2 Participants |
| ATI-50002 Topical Solution | Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale | No Improvement Measured | 9 Participants |
Secondary
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
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.
Time frame: Baseline to 52 Weeks
Population: This measurement only applies to men participating in the study. Variances from participant low section are the result of missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-50002 Topical Solution | Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale | Improvement from Type V to Type IV | 1 Participants |
| ATI-50002 Topical Solution | Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale | Improvement from Type IV to Type III Vertex | 1 Participants |
| ATI-50002 Topical Solution | Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale | Improvement from Type III Vertex to Type III | 1 Participants |
| ATI-50002 Topical Solution | Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale | Improvement from Type V to Type III Vertex | 1 Participants |
| ATI-50002 Topical Solution | Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale | Improvement from Type III Vertex to Type II | 1 Participants |
| ATI-50002 Topical Solution | Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale | No Improvement | 9 Participants |
Secondary
Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale
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.
Time frame: Baseline to 52 Weeks
Population: This measurement only applies to women participating in the study. Variances from participant low section are the result of missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-50002 Topical Solution | Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale | Improvement from Grade 4 to Grade 3 | 1 Participants |
| ATI-50002 Topical Solution | Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale | Improvement from Grade 3 to Grade 2 | 1 Participants |
| ATI-50002 Topical Solution | Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale | No Improvement | 1 Participants |
Secondary
Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale
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.
Time frame: Baseline to 26 Weeks
Population: This measurement only applies to women participating in the study. Variances from participant low section are the result of missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-50002 Topical Solution | Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale | No Measured Improvement | 5 Participants |
| ATI-50002 Topical Solution | Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale | Improvement from Grade 2 to Grade 1 | 1 Participants |
| ATI-50002 Topical Solution | Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale | Improvement from Grade 4 to Grade 3 | 1 Participants |
Secondary
Investigator Global Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
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.
Time frame: Baseline to 52 Weeks
Population: The variation in total number of patients reported across the various assessments is due to missing data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ATI-50002 Topical Solution | Investigator Global Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale | 8 Participants |
Secondary
Investigator Global Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
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.
Time frame: Baseline to 26 Weeks
Population: The variation in total number of patients reported across the various assessments is due to missing data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ATI-50002 Topical Solution | Investigator Global Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale | 16 Participants |
Secondary
Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW)
Target Area Hair Width (TAHW) will measure the cumulative width of hair in the subject's target area. Higher values represent better outcomes.
Time frame: Baseline to 52 Weeks
Population: The variation in total number of patients reported across the various assessments is due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATI-50002 Topical Solution | Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW) | 35.28 microns | Standard Deviation 901.082 |
Secondary
Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW)
Target Area Hair Width (TAHW) will measure the cumulative width of hair in the subject's target area. Higher values represent better outcomes.
Time frame: Baseline to 26 Weeks
Population: The variation in total number of patients reported across the various assessments is due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATI-50002 Topical Solution | Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW) | 403.69 microns | Standard Deviation 817.271 |
Secondary
Mean Change From Baseline in Target Area Hair Count (TAHC)
Target Area Hair Count will measure the hairs/cm2 on a subject's head. Higher values represent better outcomes.
Time frame: Baseline to 52 Weeks
Population: The variation in total number of patients reported across the various assessments is due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATI-50002 Topical Solution | Mean Change From Baseline in Target Area Hair Count (TAHC) | 1.6 hairs/cm^2 | Standard Deviation 18.92 |
Secondary
Subject Self-Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
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.
Time frame: Baseline to 26 Weeks
Population: The variation in total number of patients reported across the various assessments is due to missing data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ATI-50002 Topical Solution | Subject Self-Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale | 18 Participants |
Secondary
Subject Self-Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
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.
Time frame: Baseline to 52 Weeks
Population: The variation in total number of patients reported across the various assessments is due to missing data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ATI-50002 Topical Solution | Subject Self-Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale | 13 Participants |