Trial · NCT03315689
Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT)
NCT03315689, Phase 2, Completed, Aclaris Therapeutics, Inc.; results first posted 2020-07-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT). Trials, record NCT03315689. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03315689
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT)
- NCT number
- NCT03315689
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Conditions
- Alopecia Universalis (AU), Alopecia Totalis (AT)
- Interventions
- Vehicle, ATI-50002
- First posted
- 2017-10-20
- Last updated
- 2020-07-02
- Results first posted
- 2020-07-02
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29 | Day 2 - Day 29 | ATI-50002 levels in scalp biopsies taken at Visits 3 (Day 2) and 7 (Day 29). |
| Secondary | Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 52 | Baseline - 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. |
| Secondary | Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 40 | Baseline - 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. |
| Secondary | Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 28 | Baseline - 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. |
| Secondary | Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 28 | Baseline - 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. |
| Secondary | Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 40 | Baseline - 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. |
| Secondary | Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 52 | Baseline - 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. |
| Secondary | Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 28 | Week 4 - 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). |
| Secondary | Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 40 | Week 4 - 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). |
| Secondary | Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 52 | Week 4 - 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). |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29 | Day 2 - Day 29 | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | ng/g | MEAN |
| SECONDARY | Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 52 | Baseline - Week 52 | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | score on a scale | MEAN |
| SECONDARY | Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 40 | Baseline - Week 40 | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | score on a scale | MEAN |
| SECONDARY | Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 28 | Baseline - Week 28 | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | score on a scale | MEAN |
| SECONDARY | Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 28 | Baseline - Week 28 | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | score on a scale | MEAN |
| SECONDARY | Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 40 | Baseline - Week 40 | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | score on a scale | MEAN |
| SECONDARY | Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 52 | Baseline - Week 52 | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | score on a scale | MEAN |
| SECONDARY | Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 28 | Week 4 - Week 28 | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | score on a scale | MEAN |
| SECONDARY | Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 40 | Week 4 - Week 40 | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | score on a scale | MEAN |
| SECONDARY | Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 52 | Week 4 - Week 52 | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | score on a scale | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group43
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29 | Vehicle | V3 - Day 2 | 166.0 | Standard Deviation 83.44 | ng/g |
| Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29 | Active | V3 - Day 2 | 579.7 | Standard Deviation 322.36 | ng/g |
| Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29 | Vehicle | V7 - Day 29 | NA | Standard Deviation NA | ng/g |
| Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29 | Active | V7 - Day 29 | 5710.0 | Standard Deviation 3647.87 | ng/g |
| Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 52 | ATI-50002 0.46% Topical Solution OLE | -15.0 | Standard Deviation 16.21 | score on a scale | |
| Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 40 | ATI-50002 0.46% Topical Solution OLE | -8.8 | Standard Deviation 12.84 | score on a scale | |
| Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 28 | ATI-50002 0.46% Topical Solution OLE | -6.1 | Standard Deviation 11.91 | score on a scale | |
| Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 28 | ATI-50002 0.46% Topical Solution OLE | -7.1 | Standard Deviation 12.71 | score on a scale | |
| Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 40 | ATI-50002 0.46% Topical Solution OLE | -9.5 | Standard Deviation 10.66 | score on a scale | |
| Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 52 | ATI-50002 0.46% Topical Solution OLE | -12.0 | Standard Deviation 11.58 | score on a scale |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Period = 28 Days | STARTED | Vehicle Topical Solution | 4 | |
| Double-blind Period = 28 Days | STARTED | ATI-50002 0.46% Topical Solution | 7 | |
| Double-blind Period = 28 Days | COMPLETED | Vehicle Topical Solution | 3 | |
| Double-blind Period = 28 Days | COMPLETED | ATI-50002 0.46% Topical Solution | 7 | |
| Double-blind Period = 28 Days | NOT COMPLETED | Vehicle Topical Solution | 1 | |
| Double-blind Period = 28 Days | NOT COMPLETED | ATI-50002 0.46% Topical Solution | 0 | |
| Open Label Extension = 52 Weeks | STARTED | Vehicle Topical Solution | 0 | |
| Open Label Extension = 52 Weeks | STARTED | ATI-50002 0.46% Topical Solution | 10 | |
| Open Label Extension = 52 Weeks | COMPLETED | Vehicle Topical Solution | 0 | |
| Open Label Extension = 52 Weeks | COMPLETED | ATI-50002 0.46% Topical Solution | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events33
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Application site erosion | General disorders | Vehicle Topical Solution | 0 | 4 | 0 |
| other | Application site erosion | General disorders | ATI-50002 0.46% Topical Solution | 0 | 7 | 0 |
| other | Application site erosion | General disorders | ATI-50002 0.46% Topical Solution OLE | 1 | 10 | 1 |
| other | Peripheral swelling | General disorders | Vehicle Topical Solution | 0 | 4 | 0 |
| other | Peripheral swelling | General disorders | ATI-50002 0.46% Topical Solution | 0 | 7 | 0 |
| other | Peripheral swelling | General disorders | ATI-50002 0.46% Topical Solution OLE | 1 | 10 | |
| other | Ear infection | Infections and infestations | Vehicle Topical Solution | 0 | 4 | 0 |
| other | Ear infection | Infections and infestations | ATI-50002 0.46% Topical Solution | 0 | 7 | 0 |
| other | Ear infection | Infections and infestations | ATI-50002 0.46% Topical Solution OLE | 1 | 10 | 1 |
| other | Oral herpes | Infections and infestations | Vehicle Topical Solution | 0 | 4 | 0 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vehicle Topical Solution | 0 | 4 |
| Total, all-cause mortality | ATI-50002 0.46% Topical Solution | 0 | 7 |
| Total, all-cause mortality | ATI-50002 0.46% Topical Solution OLE | 0 | 10 |
| Total, other adverse events | Vehicle Topical Solution | 1 | 4 |
| Total, other adverse events | ATI-50002 0.46% Topical Solution | 1 | 7 |
| Total, other adverse events | ATI-50002 0.46% Topical Solution OLE | 7 | 10 |
| Total, serious adverse events | Vehicle Topical Solution | 0 | 4 |
| Total, serious adverse events | ATI-50002 0.46% Topical Solution | 0 | 7 |
| Total, serious adverse events | ATI-50002 0.46% Topical Solution OLE | 1 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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