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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-101 Solution | Active Comparator | 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 | Active Drug |
| |
| Vehicle Solution |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 106 of the study |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 106 of the study |
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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:
Subject has clinically atypical and - or rapidly growing seborrheic keratosis lesions
Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Lesser -Trelat)
Subject has a current systemic malignancy
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:
Subject has a history of sensitivity to any of the ingredients in the study medications
Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations
Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Stuart D Shanler, MD | Chief SCience Officer | 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% applied topically A-101 Solution: Active Drug |
| FG001 | Vehicle Solution | Vehicle Solution applied topically 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% applied topically A-101 Solution: Active Drug |
| BG001 | Vehicle Solution | Vehicle Solution applied topically 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 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. | ITT Population; all randomized subjects | Posted | Count of Participants | Participants | Day 106 of the study |
|
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% applied topically A-101 Solution: Active Drug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 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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| Other |
Placebo |
|
| 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 |
|
|
|
| Secondary | 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 | ITT population; all randomized subjects | Posted | Count of Participants | Participants | Day 106 of the study |
|
|
|
| 0 |
| 223 |
| 4 |
| 223 |
| 10 |
| 223 |
| EG001 | Vehicle Solution | Vehicle Solution applied topically Vehicle Solution: Placebo | 0 | 227 | 6 | 227 | 14 | 227 |
| Gastric Ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Central nervous system lesion | Nervous system disorders | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | Systematic Assessment |
|
| Mental Status Changes | Psychiatric disorders | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
|
| Actinic Keratosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Seasonal Allergy | Immune system disorders | Systematic Assessment |
|
The Institution and Investigator agree not to publish the results of this study without the prior written consent of Sponsor.