Trial · NCT01986920

Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis

NCT01986920, Phase 1, Phase 2, Completed, Aclaris Therapeutics, Inc.; results first posted 2018-12-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis. Trials, record NCT01986920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01986920

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis
NCT number: NCT01986920
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 35 participants, actual
Lead sponsor: Aclaris Therapeutics, Inc.
Conditions: Seborrheic Keratosis (SK)
Interventions: A-101 25%, A-101 32.5%, A-101 40%, A-101 Vehicle
First posted: 2013-11-19
Last updated: 2018-12-11
Results first posted: 2018-12-11
Limitations and caveats: Since each patient simultaneously participates in all four treatment groups only skin site related adverse events are reported by treatment group. Systemic adverse events are reported in all treatment groups the same.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Change in Physician Lesion Assessment Scale	Visit 2 to visit 9 (78 days)	Mean Change in Score on the Physician Lesion Assessment Scale (PLA) of each Target Lesion. The PLAS is a four point scale from 0-3 with 0 being clear and 3 being the worst lesion. The primary effectiveness will consist of the mean change from Visit 2 to Visit 9 in PLA performed using Analysis of Covariance (ANCOVA) with Visit 2 PLAS as the covariate. Comparisons between vehicle and each active treatment group will be performed within the model using least-squares means and the common error term.
Secondary	Subject's Self Assessment Scale	Visit 9 (Day 78)	Subjects self assessment of the condition of their lesions based on a scale of Clear (Grade 0), Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3).

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	Mean Change in Physician Lesion Assessment Scale	Visit 2 to visit 9 (78 days)	A total of 35 subjects were enrolled with 34 subjects in the analysis population. Each target lesion on a subject was treated with one of the 4 study medications in a random fashion.	Change in Score on a scale	MEAN
SECONDARY	Subject's Self Assessment Scale	Visit 9 (Day 78)	A total of 35 subjects were enrolled with 34 subjects in the analysis population. Each target lesion on a subject was treated with one of the 4 study medications in a random fashion.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Change in Physician Lesion Assessment Scale	A-101 25%		-0.47	Standard Deviation 0.66	Change in Score on a scale
Mean Change in Physician Lesion Assessment Scale	A-101 32.5%		-0.88	Standard Deviation 0.73	Change in Score on a scale
Mean Change in Physician Lesion Assessment Scale	A-101 40%		-1.12	Standard Deviation 0.81	Change in Score on a scale
Mean Change in Physician Lesion Assessment Scale	A-101 Vehicle		-0.15	Standard Deviation 0.36	Change in Score on a scale
Subject's Self Assessment Scale	A-101 25%	Clear	7		Participants
Subject's Self Assessment Scale	A-101 32.5%	Clear	09		Participants
Subject's Self Assessment Scale	A-101 40%	Clear	08		Participants
Subject's Self Assessment Scale	A-101 Vehicle	Clear	01		Participants
Subject's Self Assessment Scale	A-101 25%	Mild	12		Participants
Subject's Self Assessment Scale	A-101 32.5%	Mild	09		Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow48

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Units counted
A- 101 25%	STARTED	A-101 25%	35	35
A- 101 25%	STARTED	A-101 32.5%	0	0
A- 101 25%	STARTED	A-101 40%	0	0
A- 101 25%	STARTED	A-101 Vehicle	0	0
A- 101 25%	COMPLETED	A-101 25%	34	34
A- 101 25%	COMPLETED	A-101 32.5%	0	0
A- 101 25%	COMPLETED	A-101 40%	0	0
A- 101 25%	COMPLETED	A-101 Vehicle	0	0
A- 101 25%	NOT COMPLETED	A-101 25%	1	1
A- 101 25%	NOT COMPLETED	A-101 32.5%	0	0

1 to 10 of 48Source ClinicalTrials.gov

See all 48 participant flow

Adverse events84

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
other	Crusting	Skin and subcutaneous tissue disorders	A-101 25%	6	35
other	Crusting	Skin and subcutaneous tissue disorders	A-101 32.5%	12	35
other	Crusting	Skin and subcutaneous tissue disorders	A-101 40%	15	35
other	Crusting	Skin and subcutaneous tissue disorders	A-101 Vehicle	0	35
other	Erythema	Skin and subcutaneous tissue disorders	A-101 25%	8	35
other	Erythema	Skin and subcutaneous tissue disorders	A-101 32.5%	17	35
other	Erythema	Skin and subcutaneous tissue disorders	A-101 40%	19	35
other	Erythema	Skin and subcutaneous tissue disorders	A-101 Vehicle	1	35
other	Hyperpigmentation	Skin and subcutaneous tissue disorders	A-101 25%	1	35
other	Hyperpigmentation	Skin and subcutaneous tissue disorders	A-101 32.5%	1	35

1 to 10 of 84Source ClinicalTrials.gov

See all 84 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	A-101 25%	0	35
Total, all-cause mortality	A-101 32.5%	0	35
Total, all-cause mortality	A-101 40%	0	35
Total, all-cause mortality	A-101 Vehicle	0	35
Total, other adverse events	A-101 25%	21	35
Total, other adverse events	A-101 32.5%	21	35
Total, other adverse events	A-101 40%	25	35
Total, other adverse events	A-101 Vehicle	25	35
Total, serious adverse events	A-101 25%	1	35
Total, serious adverse events	A-101 32.5%	1	35

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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