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Open label study to assess safety, tolerability, and efficacy of ATI-50002 in male and female subjects with androgenetic alopecia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATI-50002 Topical Solution | Experimental | 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. Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATI-50002 | Drug | ATI-50002 Topical Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 26 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 52 Weeks |
| Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW) |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Shanler, MD | Aclaris Therapeutics, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aclaris Investigational Site | Denver | Colorado | 80210 | United States | ||
| Aclaris Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 26 Week Open Label |
|
| ||||||||||||||||||||||||
| 26 Week Extension |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The variation in total number of patients reported across the various assessments is due to missing data. | Posted | Mean | Standard Deviation | hairs/cm^2 | Baseline to 26 Weeks |
|
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."
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (21.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aclaris Clinical Operations | Aclaris Therapeutics, Inc. | 1-833-225-2747 | clinicaloperations@aclaristx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 24, 2019 | Oct 5, 2020 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 15, 2018 | Oct 5, 2020 | ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 23, 2019 | Oct 6, 2020 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Target Area Hair Width (TAHW) will measure the cumulative width of hair in the subject's target area. Higher values represent better outcomes. |
| Baseline to 26 Weeks |
| 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. | Baseline to 52 Weeks |
| 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. | Baseline to 26 Weeks |
| 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. | Baseline to 52 Weeks |
| 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. | Baseline to 26 Weeks |
| 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. | Baseline to 52 Weeks |
| 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. | Baseline to 26 Weeks |
| 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. | Baseline to 52 Weeks |
| 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. | Baseline to 26 Weeks |
| 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. | Baseline to 52 Weeks |
| Portland |
| Oregon |
| 97210 |
| United States |
| Aclaris Investigational Site | Austin | Texas | 78759 | United States |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity was only self-reported for those participants identifying as "White". | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Fitzpatrick Skin Type | Count of Participants | Participants |
|
| Sinclair Grade (Females) | 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. | Sinclair grading only applies to those participants that are Female. | Count of Participants | Participants |
|
| Norwood-Hamilton Classification | 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 | Norwood-Hamilton Classification only applies to those participants that are Male. | Count of Participants | Participants |
|
| Prior Therapies for Androgenetic Alopecia | A single study patient may have tried more than one prior therapy. | Count of Participants | Participants |
|
| Time since Diagnosis of Androgenetic Alopecia | Mean | Standard Deviation | years |
|
| Age at Diagnosis of Androgenetic Alopecia | Mean | Standard Deviation | years |
|
|
|
| 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. | The variation in total number of patients reported across the various assessments is due to missing data. | Posted | Mean | Standard Deviation | hairs/cm^2 | Baseline to 52 Weeks |
|
|
|
| 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. | The variation in total number of patients reported across the various assessments is due to missing data. | Posted | Mean | Standard Deviation | microns | Baseline to 26 Weeks |
|
|
|
| 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. | The variation in total number of patients reported across the various assessments is due to missing data. | Posted | Mean | Standard Deviation | microns | Baseline to 52 Weeks |
|
|
|
| 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. | The variation in total number of patients reported across the various assessments is due to missing data. | Posted | Count of Participants | Participants | Baseline to 26 Weeks |
|
|
|
| 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. | The variation in total number of patients reported across the various assessments is due to missing data. | Posted | Count of Participants | Participants | Baseline to 52 Weeks |
|
|
|
| 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. | The variation in total number of patients reported across the various assessments is due to missing data. | Posted | Count of Participants | Participants | Baseline to 26 Weeks |
|
|
|
| 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. | The variation in total number of patients reported across the various assessments is due to missing data. | Posted | Count of Participants | Participants | Baseline to 52 Weeks |
|
|
|
| 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. | This measurement only applies to men participating in the study. | Posted | Count of Participants | Participants | Baseline to 26 Weeks |
|
|
|
| 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. | This measurement only applies to men participating in the study. Variances from participant low section are the result of missing data. | Posted | Count of Participants | Participants | Baseline to 52 Weeks |
|
|
|
| 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. | This measurement only applies to women participating in the study. Variances from participant low section are the result of missing data. | Posted | Count of Participants | Participants | Baseline to 26 Weeks |
|
|
|
| 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. | This measurement only applies to women participating in the study. Variances from participant low section are the result of missing data. | Posted | Count of Participants | Participants | Baseline to 52 Weeks |
|
|
|
| 0 |
| 31 |
| 1 |
| 31 |
| 18 |
| 31 |
| Photopsia | Eye disorders | MedDRA (21.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (21.1) | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Nasal herpes | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Lichen planus | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Improvement from Type III to Type III Vertex |
|
| No Improvement Measured |
|
| Improvement from Type IV to Type III Vertex |
|
| Improvement from Type III Vertex to Type III |
|
| No Improvement |
|