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This study is an open-label study designed to evaluate subject's satisfaction after treatment of seborrheic keratoses with A-101 40%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-101 Topical Solution | Experimental | Open Label Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A-101 Topical Solution | Drug | A-101 Topical Solution applied Day 1, Day 15 and Day 29 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction | Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution | Day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Treatment | Effectiveness of treatment as measured by the Physician Lesion Assessment scale. The Physician Lesion Assessment Scale (PLA) is a 4 point scale used by the investigator to assess each subjects SK lesion. PLA=0 (Clear);PLA=1 (Near Clear; not elevated); PLA=2 (Thin;thickness </= 1 mm); PLA=3 (Thick; thickness > 1 mm). | Day 113 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Gordon, MD | Aclaris Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aclaris Investigational Site | Fort Washington | Pennsylvania | 19034 | United States | ||
| Aclaris Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | A-101 Topical Solution | Open Label Arm A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A-101 Topical Solution | Open Label Arm A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Subject Satisfaction | Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution | Posted | Count of Participants | Participants | Day 113 |
|
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17 weeks; The reporting period for SAEs began when the subject signed the informed consent form. Non serious clinical AEs were collected following the application of the study drug at Visit 2 and continued through Visit 11. All safety reporting (AEs and SAEs) was concluded at Visit 11 (Day 113).
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication.
Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.
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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 Topical Solution | Open Label Arm A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eyelid Oedema | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Director Clinical Operations | Aclaris Therapeutics | 4843247933 | jschnyder@aclaristx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 18, 2018 | Jun 5, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 13, 2018 | Jun 5, 2019 | SAP_001.pdf |
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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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| Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction | Effectiveness of treatment assessed by PLA (4-point scale) compared to subject reported satisfaction with treatment. The PLA scale is a 4 point scale used by the investigator to assess each subject's SK lesion. | Day 113 |
| Knoxville |
| Tennessee |
| 37922 |
| United States |
| Aclaris Investigational Site | Austin | Texas | 78759 | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Effectiveness of Treatment | Effectiveness of treatment as measured by the Physician Lesion Assessment scale. The Physician Lesion Assessment Scale (PLA) is a 4 point scale used by the investigator to assess each subjects SK lesion. PLA=0 (Clear);PLA=1 (Near Clear; not elevated); PLA=2 (Thin;thickness </= 1 mm); PLA=3 (Thick; thickness > 1 mm). | Posted | Mean | Standard Deviation | score on a scale (PLA) | Day 113 |
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| Secondary | Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction | Effectiveness of treatment assessed by PLA (4-point scale) compared to subject reported satisfaction with treatment. The PLA scale is a 4 point scale used by the investigator to assess each subject's SK lesion. | Posted | Number | point bi-serial correlation coefficient | Day 113 |
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| 0 |
| 41 |
| 0 |
| 41 |
| 8 |
| 41 |
| Administration site discomfort | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Administration site irritation | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Tooth extraction | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
|
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