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This is an open-label safety study. During this study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face.
This is an open-label safety 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 a maximum of 4 times.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-101 Solution | Experimental | A-101 Solution 40% administered once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A-101 Solution | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Lesion Clearance | Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment (PWA) Scale. The PWA scale is a 4 point scale used by the investigator to assess each subject target SK Lesion. | Study day 148 |
| Measure | Description | Time Frame |
|---|---|---|
| Per Subject Percent of Lesion Clearance | Physician Lesion Assessment (PWA) average Per-Subject Percent of target lesions judged to be clear at Visit 12 in the per protocol population. The PWA scale is a 4 point scale used by the investigator to assess the subject's Target SK lesions. | Day 148 |
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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 | Aclaris Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aclaris Therapeutics, Inc. | Malvern | Pennsylvania | 19355 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | A-101 Solution | A-101 Solution 40% administered topically for a maximum of 4 treatment visits A-101 Solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT Population
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| ID | Title | Description |
|---|---|---|
| BG000 | A-101 Solution | A-101 Solution 40% administered topically for a maximum of 4 treatment visits A-101 Solution |
| 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 Lesion Clearance | Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment (PWA) Scale. The PWA scale is a 4 point scale used by the investigator to assess each subject target SK Lesion. | ITT Population | Posted | Count of Participants | Participants | Study day 148 |
|
|
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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 topically for a maximum of 4 treatment visits A-101 Solution |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | 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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| 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 | Per Subject Percent of Lesion Clearance | Physician Lesion Assessment (PWA) average Per-Subject Percent of target lesions judged to be clear at Visit 12 in the per protocol population. The PWA scale is a 4 point scale used by the investigator to assess the subject's Target SK lesions. | Per Protocol Population | Posted | Mean | Standard Deviation | percentage of lesions cleared | Day 148 |
|
|
|
| 0 |
| 147 |
| 0 |
| 147 |
| 14 |
| 147 |
| Seasonal Allergy | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Actinic Keratosis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nasopharyngitis | 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