Trial Outcomes & Findings for Study of A-101 for the Treatment of Seborrheic Keratosis (NCT NCT02260180)

Last Updated: 2020-12-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

119 participants

Primary outcome timeframe

Day 106

Results posted on

2020-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	A-101 40% Topical Solution A-101 40% Topical Solution A-101: Topical Solution	A-101 32.5% Topical Solution A-101 32.5% Topical Solution A-101: Topical Solution	A-101 Vehicle Topical Solution A-101 0% Topical Solution (vehicle) A-101: Topical Solution
Overall Study STARTED	39	39	41
Overall Study COMPLETED	37	39	40
Overall Study NOT COMPLETED	2	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	A-101 40% Topical Solution A-101 40% Topical Solution A-101: Topical Solution	A-101 32.5% Topical Solution A-101 32.5% Topical Solution A-101: Topical Solution	A-101 Vehicle Topical Solution A-101 0% Topical Solution (vehicle) A-101: Topical Solution
Overall Study Adverse Event	2	0	1

Baseline Characteristics

Study of A-101 for the Treatment of Seborrheic Keratosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A-101 40% n=39 Participants A-101 40% Topical Solution	A-101 32.5% n=39 Participants A-101 32.5% Topical Solution	A-101 Vehicle Topical Solution n=41 Participants A-101 0% Topical Solution (vehicle)	Total n=119 Participants Total of all reporting groups
Age, Customized Age	71 years n=5 Participants	71 years n=7 Participants	67 years n=5 Participants	70 years n=4 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	24 Participants n=7 Participants	20 Participants n=5 Participants	65 Participants n=4 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants	54 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	39 Participants n=7 Participants	41 Participants n=5 Participants	118 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 106

Outcome measures

Outcome measures
Measure	A-101 40% n=37 Participants A-101 40% Topical Solution	A-101 32.5% n=39 Participants A-101 32.5% Topical Solution	A-101 Vehicle Topical Solution n=40 Participants A-101 0% Topical Solution (vehicle)
Percentage of PLA Responders With Target Lesion Clear (PLA = 0) in Each Arm at Visit 8.	22 Participants	18 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 106

Population: Participants completing the study.

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.

Outcome measures

Outcome measures
Measure	A-101 40% n=37 Participants A-101 40% Topical Solution	A-101 32.5% n=39 Participants A-101 32.5% Topical Solution	A-101 Vehicle Topical Solution n=40 Participants A-101 0% Topical Solution (vehicle)
Mean Change From Baseline PLA Score at Visit 8	-1.7 score on a scale Standard Deviation 1.11	-1.4 score on a scale Standard Deviation 1.14	-0.1 score on a scale Standard Deviation 0.56

Adverse Events

A-101 40%

Serious events: 3 serious events

Other events: 13 other events

Deaths: 1 deaths

A-101 32.5%

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

A-101 Vehicle Topical Solution

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	A-101 40% n=39 participants at risk A-101 40% Topical Solution A-101: Topical Solution	A-101 32.5% n=39 participants at risk A-101 32.5% Topical Solution A-101: Topical Solution	A-101 Vehicle Topical Solution n=41 participants at risk A-101 0% Topical Solution (vehicle) A-101: Topical Solution
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events (TESAEs) had a start date on or after the date of Visit 1 (Screening). Collection continued through the patients last visit or the end of the study, visit 8 (Day 106.) An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events (TESAEs) had a start date on or after the date of Visit 1 (Screening). Collection continued through the patients last visit or the end of the study, visit 8 (Day 106.) An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.	2.4% 1/41 • Number of events 1 • Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events (TESAEs) had a start date on or after the date of Visit 1 (Screening). Collection continued through the patients last visit or the end of the study, visit 8 (Day 106.) An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) metastatic neoplasm	2.6% 1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events (TESAEs) had a start date on or after the date of Visit 1 (Screening). Collection continued through the patients last visit or the end of the study, visit 8 (Day 106.) An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events (TESAEs) had a start date on or after the date of Visit 1 (Screening). Collection continued through the patients last visit or the end of the study, visit 8 (Day 106.) An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.	0.00% 0/41 • Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events (TESAEs) had a start date on or after the date of Visit 1 (Screening). Collection continued through the patients last visit or the end of the study, visit 8 (Day 106.) An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.
Renal and urinary disorders Renal failure	2.6% 1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events (TESAEs) had a start date on or after the date of Visit 1 (Screening). Collection continued through the patients last visit or the end of the study, visit 8 (Day 106.) An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events (TESAEs) had a start date on or after the date of Visit 1 (Screening). Collection continued through the patients last visit or the end of the study, visit 8 (Day 106.) An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.	0.00% 0/41 • Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events (TESAEs) had a start date on or after the date of Visit 1 (Screening). Collection continued through the patients last visit or the end of the study, visit 8 (Day 106.) An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	2.6% 1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events (TESAEs) had a start date on or after the date of Visit 1 (Screening). Collection continued through the patients last visit or the end of the study, visit 8 (Day 106.) An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events (TESAEs) had a start date on or after the date of Visit 1 (Screening). Collection continued through the patients last visit or the end of the study, visit 8 (Day 106.) An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.	0.00% 0/41 • Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events (TESAEs) had a start date on or after the date of Visit 1 (Screening). Collection continued through the patients last visit or the end of the study, visit 8 (Day 106.) An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.
Nervous system disorders Dizziness	2.6% 1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events (TESAEs) had a start date on or after the date of Visit 1 (Screening). Collection continued through the patients last visit or the end of the study, visit 8 (Day 106.) An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events (TESAEs) had a start date on or after the date of Visit 1 (Screening). Collection continued through the patients last visit or the end of the study, visit 8 (Day 106.) An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.	0.00% 0/41 • Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events (TESAEs) had a start date on or after the date of Visit 1 (Screening). Collection continued through the patients last visit or the end of the study, visit 8 (Day 106.) An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.

Other adverse events

Additional Information

Judith Schnyder, Senior Director of Clinical Operations

Aclaris Therapeutics, Inc.

Phone: 1-484-329-2144

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Institution and Investigator agree not to publish the results of this study without the prior written consent of the Sponsor.
Publication restrictions are in place

Restriction type: OTHER