Trial · NCT03759340
ATI-502 Topical Solution for the Treatment of Alopecia Areata (AA), Alopecia Universalis (AU) and Alopecia Totalis (AT)
NCT03759340, Phase 2, Terminated, Aclaris Therapeutics, Inc.; results first posted 2020-09-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ATI-502 Topical Solution for the Treatment of Alopecia Areata (AA), Alopecia Universalis (AU) and Alopecia Totalis (AT). Trials, record NCT03759340. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03759340
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ATI-502 Topical Solution for the Treatment of Alopecia Areata (AA), Alopecia Universalis (AU) and Alopecia Totalis (AT)
- NCT number
- NCT03759340
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Conditions
- Alopecia Areata, Alopecia Universalis, Alopecia Totalis
- Interventions
- ATI 502 0.46% Topical Solution
- First posted
- 2018-11-30
- Last updated
- 2020-10-06
- Results first posted
- 2020-09-17
- Limitations and caveats
The ATI-502-AA-203 study was terminated early due to lack of efficacy in a similarly designed study with ATI-502 Topical Solution. Due to the premature termination, the secondary efficacy analyses outlined in the protocol were not performed.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Severity of Alopecia Tool (SALT) Score | Baseline to Week 24 | 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. 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 by adding the percentage hair loss in the various areas (i.e. top, back, each side) of the scalp. For the primary endpoint, the primary efficacy variable was the mean relative percent change from the original baseline visit in study ATI-501-AUAT-201 and the SALT score at Week 24 on study ATI-502-AA-203. This represents the percentage of hair regrowth. It was calculated as the mean of the changes from baseline SALT score to the SALT score at Week 24, divided by baseline SALT score and expressed as a percentage. |
| Secondary | Mean Relative Percent Change From Baseline SALT Score | Baseline to Week 24 | Mean Relative Percent Change from Baseline (from the current study ATI-502-AA-203) in Severity of Alopecia Tool (SALT). SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss. A lower SALT score is a better outcome. A higher relative percent change is better. |
| Secondary | Proportion of Subjects Achieving a SALT50 (Defined as a ≥ 50% Improvement From Baseline in SALT) by Visit | Baseline to Week 24 | Proportion of subjects achieving a SALT 50 (defined as a ≥ 50% improvement from baseline in SALT) by visit 6. SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss. |
| Secondary | Proportion of Subjects Achieving a SALT 75 (Defined as a ≥ 75% Improvement From Baseline in SALT) by Visit | Baseline to Week 24 | Proportion of subjects achieving SALT 75 (defined as a ≥ 75% improvement from baseline in SALT) by visit 6 SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss. A bigger percent change is a more positive score. |
| Secondary | Durability of Response | Baseline to Week 24 | Durability of response: Proportion of subjects achieving a SALT 50 or SALT 75 at Week 24 (in study ATI-501-AUAT-201) and maintaining that response at week 24 in ATI-502-AA-203 study. |
| Secondary | Change From Baseline in the Physician Global Impression of Severity (PhGIS) | Baseline to Week 24 | Change from Baseline in the PhGIS by visit. The PhGIS is a 5 point scale from Mild to Extremely Severe. Mild is a better outcome. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the Severity of Alopecia Tool (SALT) Score | Baseline to Week 24 | Only 8 of the 56 enrolled participants had efficacy measures on Day 169 (primary endpoint) of the ATI-502-AA-203 study. Based on this limited data set, the maintenance of, or new hair regrowth cannot be adequately assessed from this study. | Percent Change from Baseline | MEAN |
| SECONDARY | Mean Relative Percent Change From Baseline SALT Score | Baseline to Week 24 | Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed. | ||
| SECONDARY | Proportion of Subjects Achieving a SALT50 (Defined as a ≥ 50% Improvement From Baseline in SALT) by Visit | Baseline to Week 24 | Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed. | ||
| SECONDARY | Proportion of Subjects Achieving a SALT 75 (Defined as a ≥ 75% Improvement From Baseline in SALT) by Visit | Baseline to Week 24 | Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed. | ||
| SECONDARY | Durability of Response | Baseline to Week 24 | Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed. | ||
| SECONDARY | Change From Baseline in the Physician Global Impression of Severity (PhGIS) | Baseline to Week 24 | Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed. |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Severity of Alopecia Tool (SALT) Score | ATI 502 0.46% Topical Solution | -15.72 | Standard Deviation 35.383 | Percent Change from Baseline |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ATI-502 0.46% Topical Solution | 56 | |
| Overall Study | COMPLETED | ATI-502 0.46% Topical Solution | 0 | |
| Overall Study | NOT COMPLETED | ATI-502 0.46% Topical Solution | 56 |
Source ClinicalTrials.gov
Adverse events23
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 | Ear pain | Ear and labyrinth disorders | ATI 502 0.46% Topical Solution | 1 | 56 | 1 |
| other | Application site dryness | General disorders | ATI 502 0.46% Topical Solution | 2 | 56 | 2 |
| other | Application site pruritus | General disorders | ATI 502 0.46% Topical Solution | 2 | 56 | 2 |
| other | Application site rash | General disorders | ATI 502 0.46% Topical Solution | 1 | 56 | 1 |
| other | Folliculitis | Infections and infestations | ATI 502 0.46% Topical Solution | 1 | 56 | 1 |
| other | Nasopharyngitis | Infections and infestations | ATI 502 0.46% Topical Solution | 1 | 56 | 1 |
| other | Pyuria | Infections and infestations | ATI 502 0.46% Topical Solution | 1 | 56 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | ATI 502 0.46% Topical Solution | 3 | 56 | 3 |
| other | Ankle fracture | Injury, poisoning and procedural complications | ATI 502 0.46% Topical Solution | 1 | 56 | 1 |
| other | Foot fracture | Injury, poisoning and procedural complications | ATI 502 0.46% Topical Solution | 1 | 56 | 1 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ATI 502 0.46% Topical Solution | 0 | 56 |
| Total, other adverse events | ATI 502 0.46% Topical Solution | 18 | 56 |
| Total, serious adverse events | ATI 502 0.46% Topical Solution | 0 | 56 |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03759340
GET https://conductscience.org/api/trials/v1/NCT03759340/events?page=2