Trial Outcomes & Findings for A Study of A-101 Topical Solution in Subjects With Dermatosis Papulosa Nigra (NCT NCT03224598)

Last Updated: 2020-03-30

Results Overview

Efficacy endpoints will include summary statistics (frequency distributions, proportions, means, medians and standard deviations, as appropriate) by visit for the following parameters: Physician's DPN Lesion Assessment scale results per treated lesion, subject responders defined by Physician's DPN Lesion Assessment scale outcome, and changes from baseline treated lesion diameter Physician's DPN Lesion Assessment Grade Descriptor 0 Clear: no visible DPN lesion; 1. Near Clear: a slightly visible DPN lesion; lesion may be macular 2. Small: a visible DPN lesion with a diameter of less than 3 mm 3. Large : a visible DPN lesion that is elevated with a diameter of ≥3 mm

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Day 106

Results posted on

2020-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	No Medical Abrading A-101 40% without medically abrading the identified DPN prior to treatment A-101 Topical Solution 40%: A-101 Topical Solution 40%	Medically Abrading A-101 40% with the identified DPN lesions medically abraded prior to treatment A-101 Topical Solution 40%: A-101 Topical Solution 40%	Initial Cohort - no Medical Abrading initial cohort no medical abrading different treatment schedule
Overall Study STARTED	9	17	13
Overall Study COMPLETED	9	14	13
Overall Study NOT COMPLETED	0	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	No Medical Abrading A-101 40% without medically abrading the identified DPN prior to treatment A-101 Topical Solution 40%: A-101 Topical Solution 40%	Medically Abrading A-101 40% with the identified DPN lesions medically abraded prior to treatment A-101 Topical Solution 40%: A-101 Topical Solution 40%	Initial Cohort - no Medical Abrading initial cohort no medical abrading different treatment schedule
Overall Study Lost to Follow-up	0	2	0
Overall Study Other	0	1	0

Baseline Characteristics

A Study of A-101 Topical Solution in Subjects With Dermatosis Papulosa Nigra

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Medical Abrading n=9 Participants A-101 40% without medically abrading the identified DPN prior to treatment A-101 Topical Solution 40%: A-101 Topical Solution 40%	Medically Abrading n=17 Participants A-101 40% with the identified DPN lesions medically abraded prior to treatment A-101 Topical Solution 40%: A-101 Topical Solution 40%	Initial Cohort - no Medical Abrading n=13 Participants A-101 40% without medically abrading the identified DPN prior to treatment A-101 Topical Solution 40%: A-101 Topical Solution 40% initial cohort no medical abrading different treatment schedule	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	22 Participants n=4 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	13 Participants n=7 Participants	8 Participants n=5 Participants	29 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	10 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 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	9 Participants n=5 Participants	16 Participants n=7 Participants	13 Participants n=5 Participants	38 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 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
Region of Enrollment United States	9 participants n=5 Participants	17 participants n=7 Participants	13 participants n=5 Participants	39 participants n=4 Participants
Fitzpatrick Skin Type fitzpatrick 5: Rarely burns, tans darkly easily	7 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	25 Participants n=4 Participants
Fitzpatrick Skin Type fitzpatrick 6: Never burns, always tans darkly	2 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 106

Population: per-protocol

Outcome measures

Outcome measures
Measure	No Medical Abrading n=9 Participants A-101 40% without medically abrading the identified DPN prior to treatment A-101 Topical Solution 40%: A-101 Topical Solution 40%	Medically Abrading n=14 Participants A-101 40% with the identified DPN lesions medically abraded prior to treatment A-101 Topical Solution 40%: A-101 Topical Solution 40%	Initial Cohort - no Medical Abrading n=13 Participants initial cohort no medical abrading different treatment schedule
Physician's DPN Lesions Assessment	-0.75 score on a scale (PLA) Standard Deviation 0.52	-1.38 score on a scale (PLA) Standard Deviation 0.90	-0.92 score on a scale (PLA) Standard Deviation 0.95

Adverse Events

No Medical Abrading

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Medically Abrading

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Initial Cohort - no Medical Abrading

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	No Medical Abrading n=9 participants at risk A-101 40% without medically abrading the identified DPN prior to treatment A-101 Topical Solution 40%: A-101 Topical Solution 40%	Medically Abrading n=17 participants at risk A-101 40% with the identified DPN lesions medically abraded prior to treatment A-101 Topical Solution 40%: A-101 Topical Solution 40%	Initial Cohort - no Medical Abrading n=13 participants at risk initial cohort no medical abrading different treatment schedule
Eye disorders eye pain	0.00% 0/9 • 106 days An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. assessed at all visits	0.00% 0/17 • 106 days An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. assessed at all visits	7.7% 1/13 • Number of events 1 • 106 days An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. assessed at all visits
Eye disorders Lacrimation increased	0.00% 0/9 • 106 days An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. assessed at all visits	0.00% 0/17 • 106 days An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. assessed at all visits	7.7% 1/13 • Number of events 1 • 106 days An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. assessed at all visits
Infections and infestations Upper respiratory tract infection	0.00% 0/9 • 106 days An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. assessed at all visits	5.9% 1/17 • Number of events 1 • 106 days An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. assessed at all visits	0.00% 0/13 • 106 days An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. assessed at all visits
Musculoskeletal and connective tissue disorders Muscle strain	11.1% 1/9 • Number of events 1 • 106 days An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. assessed at all visits	0.00% 0/17 • 106 days An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. assessed at all visits	0.00% 0/13 • 106 days An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. assessed at all visits
Nervous system disorders headache	0.00% 0/9 • 106 days An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. assessed at all visits	0.00% 0/17 • 106 days An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. assessed at all visits	7.7% 1/13 • Number of events 1 • 106 days An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. assessed at all visits
Skin and subcutaneous tissue disorders Rash vesicular	0.00% 0/9 • 106 days An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. assessed at all visits	5.9% 1/17 • Number of events 1 • 106 days An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. assessed at all visits	0.00% 0/13 • 106 days An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. assessed at all visits

Additional Information

Executive Director Clinical Operations

Aclaris Therapeutics

Phone: 4843247933

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place