Trial · NCT02160626
Dose-Response Profile of A-101 in Subjects With Seborrheic Keratosis
NCT02160626, Phase 2, Completed, Aclaris Therapeutics, Inc.; results first posted 2018-12-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose-Response Profile of A-101 in Subjects With Seborrheic Keratosis. Trials, record NCT02160626. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02160626
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose-Response Profile of A-101 in Subjects With Seborrheic Keratosis
- NCT number
- NCT02160626
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 172 participants, actual
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Conditions
- Seborrheic Keratosis
- Interventions
- A-101 Vehicle, A-101 (40) Topical Solution, A-101 (32.5) Topical Solution
- First posted
- 2014-06-11
- Last updated
- 2019-01-03
- Results first posted
- 2018-12-07
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Per Subject Percentage Target Lesions Judged Clear by the Physician's Lesion Assessment (PLA) | Baseline, visit 8 | Mean of per-subject percentages of target lesions judged to be clear on the PLA (PLA = 0) at end of study (Visit 8). The PLA is a four point scale from 0 being clear to 3 being most severe lesion. |
| Secondary | Mean Change From Baseline to Visit 8 in the Physician's Lesion Assessment | Baseline, visit 8 | Change from baseline PLA will be calculated for each lesion first, then per-subject mean changes from baseline will be calculated. The PLA is a score on a four scale from 0 to 3 with 0 being clear and 3 being the most severe, a lower score indicating a better result. For the mean change in this score, a larger mean change is a better result. |
| Secondary | Proportion of Subjects Who Had at Least 3 of 4 Target Lesions Judged to be Clear on the Physician Lesion Assessment (PLA =0) at Visit 8. | Baseline, visit 8 | Proportion of Subjects who had at least 3 of 4 target lesions judged to be clear on the Physician Lesion Assessment (PLA =0) at visit 8. The PLA is a 4 point scale evaluating the severity of a lesion with 0 being clear and 3 being the most severe. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Per Subject Percentage Target Lesions Judged Clear by the Physician's Lesion Assessment (PLA) | Baseline, visit 8 | Overall number of participants = number of participants completing the study per protocol. | percentage of lesions cleared | MEAN |
| SECONDARY | Mean Change From Baseline to Visit 8 in the Physician's Lesion Assessment | Baseline, visit 8 | N = number of participants completing the protocol. | units on a scale | MEAN |
| SECONDARY | Proportion of Subjects Who Had at Least 3 of 4 Target Lesions Judged to be Clear on the Physician Lesion Assessment (PLA =0) at Visit 8. | Baseline, visit 8 | N = number of subjects who completed the study per protocol. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Per Subject Percentage Target Lesions Judged Clear by the Physician's Lesion Assessment (PLA) | A-101 Vehicle | 4.82 | Standard Deviation 15.26 | percentage of lesions cleared | |
| Mean Per Subject Percentage Target Lesions Judged Clear by the Physician's Lesion Assessment (PLA) | A-101 (32.5%) Topical Solution | 26.79 | Standard Deviation 38.10 | percentage of lesions cleared | |
| Mean Per Subject Percentage Target Lesions Judged Clear by the Physician's Lesion Assessment (PLA) | A-101 (40%) Topical Solution | 45.09 | Standard Deviation 37.06 | percentage of lesions cleared | |
| Mean Change From Baseline to Visit 8 in the Physician's Lesion Assessment | A-101 Vehicle | -0.32 | Standard Deviation 0.57 | units on a scale | |
| Mean Change From Baseline to Visit 8 in the Physician's Lesion Assessment | A-101 (32.5%) Topical Solution | -0.77 | Standard Deviation 0.67 | units on a scale | |
| Mean Change From Baseline to Visit 8 in the Physician's Lesion Assessment | A-101 (40%) Topical Solution | -0.91 | Standard Deviation 0.77 | units on a scale | |
| Proportion of Subjects Who Had at Least 3 of 4 Target Lesions Judged to be Clear on the Physician Lesion Assessment (PLA =0) at Visit 8. | A-101 Vehicle | 0 | Participants | ||
| Proportion of Subjects Who Had at Least 3 of 4 Target Lesions Judged to be Clear on the Physician Lesion Assessment (PLA =0) at Visit 8. | A-101 (32.5%) Topical Solution | 9 | Participants | ||
| Proportion of Subjects Who Had at Least 3 of 4 Target Lesions Judged to be Clear on the Physician Lesion Assessment (PLA =0) at Visit 8. | A-101 (40%) Topical Solution | 11 | Participants |
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 Vehicle | 58 | |
| Overall Study | STARTED | A-101 (40%) Topical Solution | 57 | |
| Overall Study | STARTED | A-101 (32.5%) Topical Solution | 57 | |
| Overall Study | COMPLETED | A-101 Vehicle | 57 | |
| Overall Study | COMPLETED | A-101 (40%) Topical Solution | 56 | |
| Overall Study | COMPLETED | A-101 (32.5%) Topical Solution | 56 | |
| Overall Study | NOT COMPLETED | A-101 Vehicle | 1 | |
| Overall Study | NOT COMPLETED | A-101 (40%) Topical Solution | 1 | |
| Overall Study | NOT COMPLETED | A-101 (32.5%) Topical Solution | 1 |
Source ClinicalTrials.gov
Adverse events168
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 | Constipation | Gastrointestinal disorders | A-101 Vehicle | 0 | 58 | |
| other | Constipation | Gastrointestinal disorders | A-101 (32.5%) Topical Solution | 1 | 57 | |
| other | Constipation | Gastrointestinal disorders | A-101 (40%) Topical Solution | 0 | 57 | |
| other | Diarrhoea | Gastrointestinal disorders | A-101 Vehicle | 0 | 58 | |
| other | Diarrhoea | Gastrointestinal disorders | A-101 (32.5%) Topical Solution | 0 | 57 | |
| other | Diarrhoea | Gastrointestinal disorders | A-101 (40%) Topical Solution | 1 | 57 | |
| other | Gastroesophageal reflux disease | Gastrointestinal disorders | A-101 Vehicle | 0 | 58 | |
| other | Gastroesophageal reflux disease | Gastrointestinal disorders | A-101 (32.5%) Topical Solution | 1 | 57 | |
| other | Gastroesophageal reflux disease | Gastrointestinal disorders | A-101 (40%) Topical Solution | 0 | 57 | |
| other | Toothache | Gastrointestinal disorders | A-101 Vehicle | 0 | 58 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A-101 Vehicle | 0 | 58 |
| Total, all-cause mortality | A-101 (32.5%) Topical Solution | 0 | 57 |
| Total, all-cause mortality | A-101 (40%) Topical Solution | 0 | 57 |
| Total, other adverse events | A-101 Vehicle | 15 | 58 |
| Total, other adverse events | A-101 (32.5%) Topical Solution | 9 | 57 |
| Total, other adverse events | A-101 (40%) Topical Solution | 17 | 57 |
| Total, serious adverse events | A-101 Vehicle | 1 | 58 |
| Total, serious adverse events | A-101 (32.5%) Topical Solution | 0 | 57 |
| Total, serious adverse events | A-101 (40%) Topical Solution | 2 | 57 |
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/NCT02160626
GET https://conductscience.org/api/trials/v1/NCT02160626/events?page=2