A Phase 3 interventional study of A-101 Solution and Vehicle Solution in Seborrheic Keratosis, sponsored by Aclaris Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-06.
Sponsored by Aclaris Therapeutics, Inc. · Phase 3, Interventional, and Treatment
This is a randomized, double-blind, vehicle-controlled, parallel group study of A-101 Solution 40% compared with Vehicle Solution.
This is a randomized, double-blind, vehicle-controlled, parallel group study. During this study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face. The Target Lesions will be treated, by an investigational staff member other than the evaluating investigator, a maximum of two times.
364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.
This study's enrollment of 450 is above the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →Aclaris Therapeutics, Inc. is the lead sponsor of 33 studies on the registry; none are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 22 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk, extremities and face that each are eligible for treatment as defined below:
Exclusion Criteria:
Subject has used any of the following systemic therapies within the specified period prior to enrollment:
Subject has used any of the following topical therapies within the specified period or in a proximity to any Target Lesion, that in the investigator's opinion interferes with the study medication treatment or the study assessments:
Subject currently has or has had any of the following within the specified period or in a proximity to any Target Lesion that, in the investigator's opinion, interferes with the study medication treatment or the study assessments:
A-101 Solution 40% administered once
Drug: A-101 Solution
Vehicle Solution administered once
Other: Vehicle Solution
Active Drug
Placebo
Proportion of Subjects With Target Lesion Clearance as Assessed by the Physician Lesion Assessment
Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The PLA Scale is a 4 point scale used by the investigator to assess each subject's target SK Lesion.
Time frame: Day 106 of the study
Proportion of Subjects With 3 of 4 Target Lesion Clearance
Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment (PLA=0) at Visit 8
Time frame: Day 106 of the study
| Milestone | A-101 Solution | Vehicle Solution |
|---|---|---|
| Started | 223 | 227 |
| Completed | 220 | 226 |
| Not completed | 3 | 1 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Withdrawal by subject | 2 | 0 |
Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The PLA Scale is a 4 point scale used by the investigator to assess each subject's target SK Lesion.
| Participants | A-101 Solution | Vehicle Solution |
|---|---|---|
| Proportion of Subjects With Target Lesion Clearance as Assessed by the Physician Lesion Assessment | 9 | 0 |
Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment (PLA=0) at Visit 8
| Participants | A-101 Solution | Vehicle Solution |
|---|---|---|
| Proportion of Subjects With 3 of 4 Target Lesion Clearance | 30 | 0 |
Collected over Adverse events were collected from V2 (Day 1) through V8 (Day 106). Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A-101 Solution | 0/223 (0%) | 4/223 (1.8%) | 10/223 (4.5%) |
| Vehicle Solution | 0/227 (0%) | 6/227 (2.6%) | 14/227 (6.2%) |
| Event | A-101 Solution | Vehicle Solution |
|---|---|---|
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/223 | 2/227 |
| Intervertebral disc disorderMusculoskeletal and connective tissue disorders | 1/223 | 0/227 |
| Rotator cuff syndromeMusculoskeletal and connective tissue disorders | 1/223 | 0/227 |
| Central nervous system lesionNervous system disorders | 1/223 | 0/227 |
| Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders | 1/223 | 0/227 |
| Acute myocardial infarctionCardiac disorders | 0/223 | 1/227 |
| Gastric UlcerGastrointestinal disorders | 0/223 | 1/227 |
| Ischaemic strokeNervous system disorders | 0/223 | 1/227 |
| Mental Status ChangesPsychiatric disorders | 0/223 | 1/227 |
| HypertensionVascular disorders | 0/223 | 1/227 |
| Event | A-101 Solution | Vehicle Solution |
|---|---|---|
| NasopharyngitisInfections and infestations | 3/223 | 7/227 |
| Seasonal AllergyImmune system disorders | 0/223 | 4/227 |
| BronchitisInfections and infestations | 3/223 | 1/227 |
| Actinic KeratosisSkin and subcutaneous tissue disorders | 3/223 | 0/227 |
| Upper Respiratory InfectionInfections and infestations | 1/223 | 3/227 |
| Age, Categorical(Participants) | A-101 Solution | Vehicle Solution | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 72 | 55 | 127 |
| >=65 years | 151 | 172 | 323 |
| Age, Continuous(years) | A-101 Solution | Vehicle Solution | Total |
|---|---|---|---|
| Mean | 68.3 ± 8.42 | 69.1 ± 8.71 | 68.7 ± 8.57 |
| Sex: Female, Male(Participants) | A-101 Solution | Vehicle Solution | Total |
|---|---|---|---|
| Female | 138 | 126 | 264 |
| Male | 85 | 101 | 186 |
| Ethnicity (NIH/OMB)(Participants) | A-101 Solution | Vehicle Solution | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 5 | 10 |
| Not Hispanic or Latino | 214 | 216 | 430 |
| Unknown or Not Reported | 4 | 6 | 10 |
| Race (NIH/OMB)(Participants) | A-101 Solution | Vehicle Solution | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 4 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 219 | 221 | 440 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | A-101 Solution | Vehicle Solution | Total |
|---|---|---|---|
| United States | 223 | 227 | 450 |
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Aclaris Therapeutics, Inc.