Trial · NCT03468855
A Study of ATI-50002 Topical Solution for the Treatment of Vitiligo
NCT03468855, Phase 2, Completed, Aclaris Therapeutics, Inc.; results first posted 2020-11-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of ATI-50002 Topical Solution for the Treatment of Vitiligo. Trials, record NCT03468855. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03468855
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of ATI-50002 Topical Solution for the Treatment of Vitiligo
- NCT number
- NCT03468855
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Conditions
- Vitiligo
- Interventions
- ATI-50002 topical solution
- First posted
- 2018-03-19
- Last updated
- 2020-11-30
- Results first posted
- 2020-11-30
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline to Week 24 | Baseline to 24 Weeks | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 24. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. |
| Secondary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 48 | Baseline to 48 Weeks | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 48. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. |
| Secondary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 4 | Baseline to 4 Weeks | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 4. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. |
| Secondary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 8 | Baseline to 8 Weeks | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 8. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. |
| Secondary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 12 | Baseline to 12 Weeks | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 12. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. |
| Secondary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 16 | Baseline to 16 Weeks | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 4. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. |
| Secondary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Visit 2 Compared to Week 20 | Baseline to 20 Weeks | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 20. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. |
| Secondary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 32 | Baseline to 32 Weeks | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 4. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. |
| Secondary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 40 | Baseline to 40 Weeks | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 40. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. |
| Secondary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Post-treatment Week 52 | Baseline to 52 Weeks | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 52. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline to Week 24 | Baseline to 24 Weeks | score on a scale | MEAN | |
| SECONDARY | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 48 | Baseline to 48 Weeks | Subjects completing 24 weeks of treatment have the option to extend treatment for an additional 24 weeks. Subjects not wishing to continue treatment can withdraw consent. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 4 | Baseline to 4 Weeks | score on a scale | MEAN | |
| SECONDARY | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 8 | Baseline to 8 Weeks | score on a scale | MEAN | |
| SECONDARY | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 12 | Baseline to 12 Weeks | score on a scale | MEAN | |
| SECONDARY | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 16 | Baseline to 16 Weeks | score on a scale | MEAN | |
| SECONDARY | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Visit 2 Compared to Week 20 | Baseline to 20 Weeks | score on a scale | MEAN | |
| SECONDARY | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 32 | Baseline to 32 Weeks | Subjects completing 24 weeks of treatment have the option to extend treatment for an additional 24 weeks. Subjects not wishing to continue treatment can withdraw consent. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 40 | Baseline to 40 Weeks | Subjects completing 24 weeks of treatment have the option to extend treatment for an additional 24 weeks. Subjects not wishing to continue treatment can withdraw consent. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Post-treatment Week 52 | Baseline to 52 Weeks | Subjects completing 24 weeks of treatment have the option to extend treatment for an additional 24 weeks. Subjects not wishing to continue treatment can withdraw consent. | score on a scale | MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline to Week 24 | ATI-50002 0.46% Topical Solution | 2.0 | Standard Deviation 8.41 | score on a scale | |
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 48 | ATI-50002 0.46% Topical Solution | -1.4 | Standard Deviation 15.11 | score on a scale | |
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 4 | ATI-50002 0.46% Topical Solution | 0.2 | Standard Deviation 4.47 | score on a scale | |
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 8 | ATI-50002 0.46% Topical Solution | 0.5 | Standard Deviation 4.82 | score on a scale | |
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 12 | ATI-50002 0.46% Topical Solution | 0.3 | Standard Deviation 9.04 | score on a scale | |
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 16 | ATI-50002 0.46% Topical Solution | -0.8 | Standard Deviation 8.20 | score on a scale | |
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Visit 2 Compared to Week 20 | ATI-50002 0.46% Topical Solution | 1.3 | Standard Deviation 9.22 | score on a scale | |
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 32 | ATI-50002 0.46% Topical Solution | 4.2 | Standard Deviation 9.09 | score on a scale | |
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 40 | ATI-50002 0.46% Topical Solution | 1.9 | Standard Deviation 12.14 | score on a scale | |
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Post-treatment Week 52 | ATI-50002 0.46% Topical Solution | -1.4 | Standard Deviation 13.29 | score on a scale |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ATI-50002 0.46% Topical Solution | 34 | |
| Overall Study | COMPLETED | ATI-50002 0.46% Topical Solution | 23 | |
| Overall Study | NOT COMPLETED | ATI-50002 0.46% Topical Solution | 11 |
Source ClinicalTrials.gov
Adverse events52
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 | Coronary artery disease | Cardiac disorders | ATI-50002 0.46% Topical Solution | 1 | 34 | 1 |
| other | Ventricular tachycardia | Cardiac disorders | ATI-50002 0.46% Topical Solution | 1 | 34 | 1 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | ATI-50002 0.46% Topical Solution | 1 | 34 | 1 |
| other | Application site acne | General disorders | ATI-50002 0.46% Topical Solution | 2 | 34 | 3 |
| other | Application site discolouration | General disorders | ATI-50002 0.46% Topical Solution | 1 | 34 | 1 |
| other | Application site dryness | General disorders | ATI-50002 0.46% Topical Solution | 6 | 34 | 7 |
| other | Application site pain | General disorders | ATI-50002 0.46% Topical Solution | 1 | 34 | 1 |
| other | Application site rash | General disorders | ATI-50002 0.46% Topical Solution | 2 | 34 | 2 |
| other | Gastroenteritis | Infections and infestations | ATI-50002 0.46% Topical Solution | 1 | 34 | 2 |
| other | Gastroenteritis viral | Infections and infestations | ATI-50002 0.46% Topical Solution | 1 | 34 | 1 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ATI-50002 0.46% Topical Solution | 0 | 34 |
| Total, other adverse events | ATI-50002 0.46% Topical Solution | 23 | 34 |
| Total, serious adverse events | ATI-50002 0.46% Topical Solution | 2 | 34 |
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/NCT03468855
GET https://conductscience.org/api/trials/v1/NCT03468855/registered?page=2