Androgenetic AlopeciaPhase 2NCT03495817
A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution
A Phase 2 study testing ATI-50002 in people with Androgenetic Alopecia, run by Aclaris Therapeutics, Inc. at 3 sites in United States.
Trial summary
Open label study to assess safety, tolerability, and efficacy of ATI-50002 in male and female subjects with androgenetic alopecia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- ATI-50002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Mar 2018to 30 Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Aclaris Investigational Site
Austin, Texas, 78759
Aclaris Investigational Site
Denver, Colorado, 80210
Aclaris Investigational Site
Portland, Oregon, 97210
About this study
Official title: An Open-Label Safety, Tolerability, and Efficacy Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution
Open label study to assess safety, tolerability, and efficacy of ATI-50002 in male and female subjects with androgenetic alopecia.
Read the 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.
- Conditions
- Androgenetic Alopecia
- Being tested
- ATI-50002
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATI-50002Drug
ATI-50002 Topical Solution
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ATI-50002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 26 Weeks
Secondary outcomes (11)
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.
Measured: Baseline to 52 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start22 Mar 2018
- Primary completion15 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Shanler, MD, Study chair, Aclaris Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495817
- Sponsor's protocol ID
- ATI-50002-AGA-201
- Status last verified
- Nov 2020
- First submitted
- 5 Apr 2018
- Last updated
- 9 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Safety, Tolerability, and Efficacy Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution
- ClinicalTrials.gov ID
- NCT03495817
- Acronym / sponsor ID
- ATI-50002-AGA-201
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Aclaris Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Posted 9 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATI-50002 Topical Solution | Experimental | Drug: ATI-50002This 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATI-50002ATI-50002 Topical Solution | Drug | ATI-50002 Topical Solution |
Primary outcome
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.
11 secondary outcomes
Mean Change From Baseline in Target Area Hair Count (TAHC)
Time frame: Baseline to 52 Weeks
Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW)
Time frame: Baseline to 26 Weeks
Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW)
Time frame: 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
Investigator Global Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
Time frame: 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
Subject Self-Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
Time frame: Baseline to 52 Weeks
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
Time frame: Baseline to 26 Weeks
Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
Time frame: Baseline to 52 Weeks
Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale
Time frame: Baseline to 26 Weeks
Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale
Time frame: Baseline to 52 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Androgenetic Alopecia
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Shanler, MD study chair
Aclaris Therapeutics, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATI-50002 in people with Androgenetic Alopecia, run by Aclaris Therapeutics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Target Area Hair Count (TAHC) (time frame: Baseline to 26 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.