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This is a randomized, double-blind, vehicle-controlled, parallel group study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-101 Solution | Experimental | A-101 Solution 40% administered once |
|
| Vehicle Solution | Placebo Comparator | Vehicle Solution administered once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A-101 Solution | Drug |
| ||
| Vehicle Solution |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With All Target Lesions Cleared According to Physician Lesion Assessment Scale | 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 Physician Lesion Assessment Scale is a 4 point scale used by the investigator to assess the subject's target sk lesions. | Study day 106 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Lesions Cleared Scale | Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8 | Study day 106 |
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Inclusion Criteria:
Subject is at least 18 years of age
Clinical diagnosis of stable clinically typical seborrheic keratosis
Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk, extremities and face that each are eligible for treatment as defined below:
If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an active method of birth control for the duration of the study
Subject is non-pregnant and non-lactating
Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of any Target Lesion or which exposes the subject to an unacceptable risk by study participation
Subject is willing and able to follow all study instructions and to attend all study visits
Subject is able to comprehend and willing to sign an Informed Consent Form.
Exclusion Criteria:
1. Subject has clinically atypical and - or rapidly growing seborrheic keratosis lesions 2. Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Lesser -Trelat) 3. Subject has a current systemic malignancy 4. Subject has used any of the following systemic therapies within the specified period prior to enrollment:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart D Shanler, MD | Aclaris Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aclaris Therapeutics, Inc. | Malvern | Pennsylvania | 19355 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30365590 | Derived | Smith SR, Xu S, Estes E, Shanler SD. Anatomic Site-Specific Treatment Response With 40% Hydrogen Peroxide (w/w) Topical Formulation for Raised Seborrheic Keratoses: Pooled Analysis of Data from Two Phase 3 Studies. J Drugs Dermatol. 2018 Oct 1;17(10):1092-1098. |
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| ID | Title | Description |
|---|---|---|
| FG000 | A-101 Solution | A-101 Solution 40% administered once A-101 Solution |
| FG001 | Vehicle Solution | Vehicle Solution administered once Vehicle Solution: Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A-101 Solution | A-101 Solution 40% administered once A-101 Solution |
| BG001 | Vehicle Solution | Vehicle Solution administered once Vehicle Solution: Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Subjects With All Target Lesions Cleared According to Physician Lesion Assessment Scale | 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 Physician Lesion Assessment Scale is a 4 point scale used by the investigator to assess the subject's target sk lesions. | Posted | Count of Participants | Participants | Study day 106 |
|
Adverse events were collected from V2 (Day 1) through V8 (Day 106)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A-101 Solution | A-101 Solution 40% administered once A-101 Solution | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judy Schnyder, Sr. Director Clinical Operations | Aclaris Therapeutics | 484-329-2144 | jschnyder@aclaristx.com |
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| ID | Term |
|---|---|
| D017492 | Keratosis, Seborrheic |
| ID | Term |
|---|---|
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Placebo |
|
| Withdrawal by Subject |
|
| Discontinued early without completing |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percent of Lesions Cleared Scale | Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8 | Posted | Count of Participants | Participants | Study day 106 |
|
|
|
| 244 |
| 6 |
| 244 |
| 8 |
| 244 |
| EG001 | Vehicle Solution | Vehicle Solution administered once Vehicle Solution: Placebo | 0 | 243 | 4 | 243 | 7 | 243 |
| Sinus Node Dysfunction | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pubis Fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Pulmonary Contusion | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Intervertebral Disc Degeneration | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Breast Cancer Stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Precerebral artery occlusion | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| Post traumatic Stress Disorder | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
The Institution and Investigator agree not to publish the results of this study without the prior written consent of the Sponsor.