Back to resultsA Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution
Primary Purpose
Androgenetic Alopecia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ATI-50002
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia
Eligibility Criteria
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.
Sites / Locations
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ATI-50002 Topical Solution
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03495817
First Posted
April 5, 2018
Last Updated
November 16, 2020
Sponsor
Aclaris Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03495817
Brief Title
A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution
Official Title
An Open-Label Safety, Tolerability, and Efficacy Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 22, 2018 (Actual)
Primary Completion Date
October 15, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aclaris Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ATI-50002 Topical Solution
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ATI-50002
Intervention Description
ATI-50002 Topical Solution
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Target Area Hair Count (TAHC)
Description
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
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Target Area Hair Count (TAHC)
Description
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
Title
Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW)
Description
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
Title
Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW)
Description
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
Title
Investigator Global Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
Description
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
Title
Investigator Global Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
Description
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
Title
Subject Self-Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
Description
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
Title
Subject Self-Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
Description
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
Title
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
Description
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
Title
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
Description
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
Title
Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale
Description
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
Title
Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Shanler, MD
Organizational Affiliation
Aclaris Therapeutics, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Aclaris Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Aclaris Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Aclaris Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution
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