Trial · NCT02260180
Study of A-101 for the Treatment of Seborrheic Keratosis
NCT02260180, Phase 2, Completed, Aclaris Therapeutics, Inc.; results first posted 2018-12-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of A-101 for the Treatment of Seborrheic Keratosis. Trials, record NCT02260180. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02260180
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of A-101 for the Treatment of Seborrheic Keratosis
- NCT number
- NCT02260180
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 119 participants, actual
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Conditions
- Seborrheic Keratosis
- Interventions
- A-101
- First posted
- 2014-10-09
- Last updated
- 2020-12-02
- Results first posted
- 2018-12-06
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of PLA Responders With Target Lesion Clear (PLA = 0) in Each Arm at Visit 8. | Day 106 | The primary effectiveness analysis was a comparison between each A-101 group and the vehicle group based on the percentage with target lesions judged to be clear on the PLA (PLA = 0) at Visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better. |
| Secondary | Mean Change From Baseline PLA Score at Visit 8 | Day 106 | A secondary efficacy analysis was the mean change from baseline PLA Score at visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better. A lower (more negative) mean change is a better outcome. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of PLA Responders With Target Lesion Clear (PLA = 0) in Each Arm at Visit 8. | Day 106 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Change From Baseline PLA Score at Visit 8 | Day 106 | Participants completing the study. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of PLA Responders With Target Lesion Clear (PLA = 0) in Each Arm at Visit 8. | A-101 40% | 22 | Participants | ||
| Percentage of PLA Responders With Target Lesion Clear (PLA = 0) in Each Arm at Visit 8. | A-101 32.5% | 18 | Participants | ||
| Percentage of PLA Responders With Target Lesion Clear (PLA = 0) in Each Arm at Visit 8. | A-101 Vehicle Topical Solution | 1 | Participants | ||
| Mean Change From Baseline PLA Score at Visit 8 | A-101 40% | -1.7 | Standard Deviation 1.11 | score on a scale | |
| Mean Change From Baseline PLA Score at Visit 8 | A-101 32.5% | -1.4 | Standard Deviation 1.14 | score on a scale | |
| Mean Change From Baseline PLA Score at Visit 8 | A-101 Vehicle Topical Solution | -0.1 | Standard Deviation 0.56 | score on a scale |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A-101 40% Topical Solution | 39 | |
| Overall Study | STARTED | A-101 32.5% Topical Solution | 39 | |
| Overall Study | STARTED | A-101 Vehicle Topical Solution | 41 | |
| Overall Study | COMPLETED | A-101 40% Topical Solution | 37 | |
| Overall Study | COMPLETED | A-101 32.5% Topical Solution | 39 | |
| Overall Study | COMPLETED | A-101 Vehicle Topical Solution | 40 | |
| Overall Study | NOT COMPLETED | A-101 40% Topical Solution | 2 | |
| Overall Study | NOT COMPLETED | A-101 32.5% Topical Solution | 0 | |
| Overall Study | NOT COMPLETED | A-101 Vehicle Topical Solution | 1 |
Source ClinicalTrials.gov
Adverse events90
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 | Eustacian Tube Obstruction | Ear and labyrinth disorders | A-101 40% | 0 | 39 | 0 |
| other | Eustacian Tube Obstruction | Ear and labyrinth disorders | A-101 32.5% | 0 | 39 | 0 |
| other | Eustacian Tube Obstruction | Ear and labyrinth disorders | A-101 Vehicle Topical Solution | 1 | 41 | 1 |
| other | Cataract | Eye disorders | A-101 40% | 1 | 39 | 1 |
| other | Cataract | Eye disorders | A-101 32.5% | 0 | 39 | 0 |
| other | Cataract | Eye disorders | A-101 Vehicle Topical Solution | 0 | 41 | 0 |
| other | Gastroenteritis | Gastrointestinal disorders | A-101 40% | 1 | 39 | 1 |
| other | Gastroenteritis | Gastrointestinal disorders | A-101 32.5% | 0 | 39 | 0 |
| other | Gastroenteritis | Gastrointestinal disorders | A-101 Vehicle Topical Solution | 0 | 41 | 0 |
| other | Seasonal Allergy | Immune system disorders | A-101 40% | 3 | 39 | 3 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A-101 40% | 1 | 39 |
| Total, all-cause mortality | A-101 32.5% | 0 | 39 |
| Total, all-cause mortality | A-101 Vehicle Topical Solution | 0 | 41 |
| Total, other adverse events | A-101 40% | 13 | 39 |
| Total, other adverse events | A-101 32.5% | 7 | 39 |
| Total, other adverse events | A-101 Vehicle Topical Solution | 12 | 41 |
| Total, serious adverse events | A-101 40% | 3 | 39 |
| Total, serious adverse events | A-101 32.5% | 0 | 39 |
| Total, serious adverse events | A-101 Vehicle Topical Solution | 1 | 41 |
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/NCT02260180
GET https://conductscience.org/api/trials/v1/NCT02260180/events?page=2