A Phase 2 interventional study of Vehicle and ATI-50002 in Alopecia Universalis (AU) and Alopecia Totalis (AT), sponsored by Aclaris Therapeutics, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-02.
Sponsored by Aclaris Therapeutics, Inc. · Phase 2, Interventional, and Treatment
Among 17 studies in Alopecia universalis with a site in United States — 2 open to participants now, 4 under way, 1 of them phase 3. Alopecia universalis · United States.
Among the 17 studies in Alopecia universalis with a site in United States, this one is the 14th largest by enrollment of the 16 interventional ones, is the only one that started in 2017, is one of 11 in phase 2, and was the 8th registered.
31 studies on the registry are indexed under Alopecia universalis; 6 are open to participants now.
This study's enrollment of 11 is below the median of 40 across 24 interventional studies indexed under Alopecia universalis.
Browse Alopecia universalis studies →2 of the 17 studies in Alopecia universalis with a site in United States are open now, in 11 countries. Each count lists the studies.
Of the 4 Alopecia universalis studies recruiting now, 2 (50%) set no upper age limit and 2 (50%) stop at 75 or younger; 3 take children under 18; 0 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →17 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2017.
Median enrollment 43 across the 16 interventional studies, 3,100 across the 1 observational. Of the 13 that completed or were terminated, 12 (92%) have results posted.
9 of 17 have an industry lead sponsor. The 10 most frequent:
Aclaris Therapeutics, Inc. is the lead sponsor of 33 studies on the registry; none are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 22 (88%) have results posted.
Aclaris Therapeutics, Inc. has 3 studies filed under Alopecia universalis — fewer than ten, so there is no comparison to draw.
1 of the studies in Alopecia universalis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04011748Throne Biotechnologies Inc.Clinical Application of Stem Cell Educator Therapy in Alopecia Areata | 2027-07-30 |
Among the 17 studies in Alopecia universalis with a site in United States, from their registry updates:
The primary objective is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution compared to vehicle in subjects with AU and AT.
This study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution in patients with Alopecia Universalis and Alopecia Totalis. Concentrations of ATI-50002 in the blood and skin will be assessed after 28 days of treatment with ATI-50002 Topical Solution.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vehicle
Drug: Vehicle
ATI-50002 Topical Solution
Drug: ATI-50002
Vehicle Topical Solution
ATI-50002 Topical Solution
Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29
ATI-50002 levels in scalp biopsies taken at Visits 3 (Day 2) and 7 (Day 29).
Time frame: Day 2 - Day 29
Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 52
The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth.
Time frame: Baseline - Week 52
Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 40
The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth.
Time frame: Baseline - Week 40
Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 28
The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth.
Time frame: Baseline - Week 28
Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 28
The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.
Time frame: Baseline - Week 28
Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 40
The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.
Time frame: Baseline - Week 40
Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 52
The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.
Time frame: Baseline - Week 52
Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 28
The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).
Time frame: Week 4 - Week 28
Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 40
The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).
Time frame: Week 4 - Week 40
Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 52
The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).
Time frame: Week 4 - Week 52
Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 28
The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).
Time frame: Week 4 - Week 28
Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 40
The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).
Time frame: Week 4 - Week 40
Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 52
The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).
Time frame: Week 4 - Week 52
Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 28
The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata.
Time frame: Week 28
Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 40
The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata.
Time frame: Week 40
Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 52
The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata.
Time frame: Week 52
Open Label Extension: Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 24 From Baseline
The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome).
Time frame: Baseline - Week 24
Open Label Extension: Severity of Alopecia Tool (SALT Scores), Relative Percent Regrowth (%) at Week 40 From Baseline
The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome).
Time frame: Baseline - Week 40
Open Label Extension: The Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 52 From Baseline
The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome).
Time frame: Baseline - Week 52
Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 24 Weeks
The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome).
Time frame: Baseline - Week 24
Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 40 Weeks
The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome).
Time frame: Baseline - Week 40
Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 52 Weeks
The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome).
Time frame: Baseline - Week 52
| Milestone | Vehicle Topical Solution | ATI-50002 0.46% Topical Solution |
|---|---|---|
| Started | 4 | 7 |
| Completed | 3 | 7 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Milestone | Vehicle Topical Solution | ATI-50002 0.46% Topical Solution |
|---|---|---|
| Started | 0 | 10 |
| Completed | 0 | 7 |
| Not completed | 0 | 3 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 |
ATI-50002 levels in scalp biopsies taken at Visits 3 (Day 2) and 7 (Day 29).
| ng/g | Vehicle | Active |
|---|---|---|
| V3 - Day 2 | 166.0 ± 83.44 | 579.7 ± 322.36 |
| V7 - Day 29 | NA ± NA | 5710.0 ± 3647.87 |
The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth.
| score on a scale | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 52 | -15.0 ± 16.21 |
The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth.
| score on a scale | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 40 | -8.8 ± 12.84 |
The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth.
| score on a scale | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 28 | -6.1 ± 11.91 |
The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.
| score on a scale | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 28 | -7.1 ± 12.71 |
The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.
| score on a scale | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 40 | -9.5 ± 10.66 |
The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.
| score on a scale | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 52 | -12.0 ± 11.58 |
The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).
| score on a scale | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 28 | 0.4 ± 0.90 |
The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).
| score on a scale | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 40 | 0.5 ± 1.58 |
The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).
| score on a scale | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 52 | 0.6 ± 1.38 |
The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).
| score on a scale | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 28 | 0.1 ± 1.16 |
The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).
| score on a scale | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 40 | 0.6 ± 1.11 |
The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).
| score on a scale | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 52 | 0.8 ± 1.19 |
The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata.
| Participants | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| 1: Extremely Satisfied | 0 |
| 2: Moderately Satisfied | 2 |
| 3: A little Satisfied | 1 |
| 4: Neither Satisfied or Dissatisfied | 1 |
| 5: A little Dissatisfied | 0 |
| 6: Moderately Dissatisfied | 1 |
| 7: Extremely Dissatisfied | 3 |
The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata.
| Participants | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| 1: Extremely Satisfied | 0 |
| 2: Moderately Satisfied | 2 |
| 3: A little Satisfied | 0 |
| 4: Neither Satisfied or Dissatisfied | 1 |
| 5: A little Dissatisfied | 0 |
| 6: Moderately Dissatisfied | 0 |
| 7: Extremely Dissatisfied | 1 |
The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata.
| Participants | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| 1: Extremely Satisfied | 0 |
| 2: Moderately Satisfied | 2 |
| 3: A little Satisfied | 0 |
| 4: Neither Satisfied or Dissatisfied | 1 |
| 5: A little Dissatisfied | 0 |
| 6: Moderately Dissatisfied | 0 |
| 7: Extremely Dissatisfied | 1 |
The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome).
| percent change | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| Open Label Extension: Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 24 From Baseline | 6.3 ± 12.14 |
The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome).
| percent change | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| Open Label Extension: Severity of Alopecia Tool (SALT Scores), Relative Percent Regrowth (%) at Week 40 From Baseline | 9.0 ± 13.01 |
The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome).
| percent change | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| Open Label Extension: The Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 52 From Baseline | 15.5 ± 16.77 |
The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome).
| percent change | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 24 Weeks | 7.2 ± 12.88 |
The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome).
| percent change | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 40 Weeks | 9.6 ± 10.81 |
The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome).
| percent change | ATI-50002 0.46% Topical Solution OLE |
|---|---|
| Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 52 Weeks | 12.2 ± 11.74 |
Collected over Double blind period = 28 days; Open label extension period = 12 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vehicle Topical Solution | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) |
| ATI-50002 0.46% Topical Solution | 0/7 (0%) | 0/7 (0%) | 1/7 (14.3%) |
| ATI-50002 0.46% Topical Solution OLE | 0/10 (0%) | 1/10 (10%) | 7/10 (70%) |
| Event | Vehicle Topical Solution | ATI-50002 0.46% Topical Solution | ATI-50002 0.46% Topical Solution OLE |
|---|---|---|---|
| DepressionPsychiatric disorders | 0/4 | 0/7 | 1/10 |
| Event | Vehicle Topical Solution | ATI-50002 0.46% Topical Solution | ATI-50002 0.46% Topical Solution OLE |
|---|---|---|---|
| MigraineNervous system disorders | 1/4 | 0/7 | 0/10 |
| Hypertensive urgencyVascular disorders | 0/4 | 1/7 | 0/10 |
| Application site erosionGeneral disorders | 0/4 | 0/7 | 1/10 |
| Peripheral swellingGeneral disorders | 0/4 | 0/7 | 1/10 |
| Ear infectionInfections and infestations | 0/4 | 0/7 | 1/10 |
| Oral herpesInfections and infestations | 0/4 | 0/7 | 1/10 |
| DehydrationMetabolism and nutrition disorders | 0/4 | 0/7 | 1/10 |
| Glucose tolerance impairedMetabolism and nutrition disorders | 0/4 | 0/7 | 1/10 |
| Vitamin D deficiencyMetabolism and nutrition disorders | 0/4 | 0/7 | 1/10 |
| Rotator cuff syndromeMusculoskeletal and connective tissue disorders | 0/4 | 0/7 | 1/10 |
| Age, Categorical(Participants) | Vehicle Topical Solution | ATI-50002 0.46% Topical Solution | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 5 | 8 |
| >=65 years | 1 | 2 | 3 |
| Sex: Female, Male(Participants) | Vehicle Topical Solution | ATI-50002 0.46% Topical Solution | Total |
|---|---|---|---|
| Female | 3 | 7 | 10 |
| Male | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Vehicle Topical Solution | ATI-50002 0.46% Topical Solution | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 2 | 4 | 6 |
| Unknown or Not Reported | 1 | 3 | 4 |
| Race (NIH/OMB)(Participants) | Vehicle Topical Solution | ATI-50002 0.46% Topical Solution | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 3 | 4 |
| White | 3 | 4 | 7 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Vehicle Topical Solution | ATI-50002 0.46% Topical Solution | Total |
|---|---|---|---|
| United States | 4 | 7 | 11 |
| Fitzpatrick Skin Type(Participants) | Vehicle Topical Solution | ATI-50002 0.46% Topical Solution | Total |
|---|---|---|---|
| I - Always Burns | 0 | 2 | 2 |
| II - Burns Easily | 3 | 2 | 5 |
| III - Burns Moderately | 0 | 0 | 0 |
| IV - Burns Minimally | 0 | 1 | 1 |
| V - Rarely Burns | 1 | 2 | 3 |
| VI - Never Burns | 0 | 0 | 0 |
| Current Clinical Type of Alopecia(Participants) | Vehicle Topical Solution | ATI-50002 0.46% Topical Solution | Total |
|---|---|---|---|
| Totalis | 1 | 3 | 4 |
| Universalis | 3 | 4 | 7 |
| Time Since Onset of Current Episode of AU or AT(Weeks) | Vehicle Topical Solution | ATI-50002 0.46% Topical Solution | Total |
|---|---|---|---|
| Mean | 145.8 ± 128.58 | 218.3 ± 122.10 | 191.9 ± 123.47 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Jun 2019, 18 months.
Results were first posted in Jul 2020, 1 year after primary completion.
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Studies of the drug tested here: Ifidancitinib