- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03495817
A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution
An Open-Label Safety, Tolerability, and Efficacy Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Colorado
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Denver, Colorado, United States, 80210
- Aclaris Investigational Site
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Oregon
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Portland, Oregon, United States, 97210
- Aclaris Investigational Site
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Texas
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Austin, Texas, United States, 78759
- Aclaris Investigational Site
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks. |
ATI-50002 Topical Solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in Target Area Hair Count (TAHC)
Time Frame: Baseline to 26 Weeks
|
Target Area Hair Count will measure the hairs/cm2 on a subject's head.
Higher values represent better outcomes.
|
Baseline to 26 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in Target Area Hair Count (TAHC)
Time Frame: Baseline to 52 Weeks
|
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)
Time Frame: 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.
|
Baseline to 26 Weeks
|
Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW)
Time Frame: Baseline to 52 Weeks
|
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
Time Frame: 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.
|
Baseline to 26 Weeks
|
Investigator Global Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
Time Frame: Baseline to 52 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.
|
Baseline to 52 Weeks
|
Subject Self-Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
Time Frame: 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.
|
Baseline to 26 Weeks
|
Subject Self-Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
Time Frame: Baseline to 52 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.
|
Baseline to 52 Weeks
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
Time Frame: 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. |
Baseline to 26 Weeks
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
Time Frame: Baseline to 52 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. |
Baseline to 52 Weeks
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale
Time Frame: 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. |
Baseline to 26 Weeks
|
Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale
Time Frame: Baseline to 52 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. |
Baseline to 52 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Stuart Shanler, MD, Aclaris Therapeutics, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATI-50002-AGA-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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