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The primary objective of this study is to evaluate the safety and effectiveness of 2 concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK) Target Lesions on the trunk, extremities and face.
The primary objective of this study is to evaluate the safety and effectiveness of 2 concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK) Target Lesions on the trunk, extremities and face.
The secondary objectives of this study include duration of response of A-101. During the study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face. For each subject, at least 1 SK Target Lesion must be on the face and at least 1 Target Lesion must be on the trunk or extremities. The Target Lesions will be treated at a maximum of two treatment visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle | Placebo Comparator | Vehicle Topical Solution |
|
| A-101 Low Dose | Active Comparator | A-101 Low Dose Topical Solution |
|
| A-101 High Dose | Active Comparator | A-101 High DoseTopical Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A-101 | Drug | Topical Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean of Per Subject Percentages of Target Lesions Judged to be Clear (PWA=0) at Visit 8 | Mean of per subject percentages of target lesions judged to be clear (PWA=0) at Visit 8 Grade Descriptor 0 Clear: no visible seborrheic keratosis lesion
| Day 106 |
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Inclusion Criteria:
Subject is able to comprehend and is willing to sign an informed consent for participation in this study.
Male or female ≥ 18 years old.
Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis.
Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk, extremities and face, with at least 1 Target Lesion on the face and at least 1 Target Lesion on the trunk or extremities. The 4 identified Target Lesions must meet the requirements as defined below:
Subject chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value/s as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization.
Woman of childbearing potential must have a negative urine pregnancy test within 14 days of the first application of study drug and agree 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 the 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.
Exclusion Criteria:
Subject has clinically atypical and /or rapidly growing seborrheic keratosis lesions.
Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser - Trelat).
Subject has current systemic malignancy.
Subject has used any of the following systemic therapies within the specified period prior to Visit 1:
Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, 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 would require the use of any topical treatment (e.g. moisturizers, sunscreen) to any of the Target Lesions 12 hours prior to any study visit.
Subject currently has or has had any of the following within the specified period prior to Visit 1 on 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), 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.
Participation in another therapeutic investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.
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| Name | Affiliation | Role |
|---|---|---|
| Stuart D Shanler, MD | Aclaris Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Dermatology and Dermatologic Surgery | Washington D.C. | District of Columbia | 20037 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle | Vehicle Topical Solution A-101: Topical Solution |
| FG001 | A-101 Low Dose | A-101 Low Dose Topical Solution A-101: Topical Solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2017 |
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| Baumann Research Institute |
| Miami |
| Florida |
| 33137 |
| United States |
| MedaPhase, Inc | Newnan | Georgia | 30263 | United States |
| Union Square Laser Dermatology | New York | New York | 10003 | United States |
| Philadelphia Institute - Dermatology | Fort Washington | Pennsylvania | 19034 | United States |
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| Greenville Dermatology | Greenville | South Carolina | 29607 | United States |
| The Skin Wellness Center, PC Clinical Research Division | Knoxville | Tennessee | 37922 | United States |
| DermResearch Inc | Austin | Texas | 78759 | United States |
| FG002 | A-101 High Dose | A-101 High DoseTopical Solution A-101: Topical Solution |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle | Vehicle Topical Solution A-101: Topical Solution |
| BG001 | A-101 Low Dose | A-101 Low Dose Topical Solution A-101: Topical Solution |
| BG002 | A-101 High Dose | A-101 High DoseTopical Solution A-101: Topical Solution |
| BG003 | Total | Total of all reporting groups |
| 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 | 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 |
|
| 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 | Mean of Per Subject Percentages of Target Lesions Judged to be Clear (PWA=0) at Visit 8 | Mean of per subject percentages of target lesions judged to be clear (PWA=0) at Visit 8 Grade Descriptor 0 Clear: no visible seborrheic keratosis lesion
| Posted | Mean | Standard Deviation | Per-Subject Percent of Lesions Clear | Day 106 | Lesions | Lesions |
|
|
|
11.5 months; Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events had a start date on or after the date of Visit 1 (Screening). Collection continued through the subject's last visit or the end of the study, visit 8 (Day 106.)
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 | Vehicle | Vehicle Topical Solution A-101: Topical Solution | 0 | 50 | 1 | 50 | 11 | 50 |
| EG001 | A-101 Low Dose | A-101 Low Dose Topical Solution A-101: Topical Solution | 0 | 103 | 2 | 103 | 18 | 103 |
| EG002 | A-101 High Dose | A-101 High DoseTopical Solution A-101: Topical Solution | 0 | 100 | 1 | 100 | 26 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pancreatic Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Syncope and Collapse | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bundle Branch Block Left | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eyelid Oedema | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ocular Hypertension | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bile Duct Obstruction | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Body Tinea | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Post operative wound infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Tooth injury | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood osmolarity decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Benign neoplasm of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Parkinson's disease | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Director, Clinical Operations | Aclaris Therapeutics | 4843247933 | jschnyder@aclaristx.com |
| May 2, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D017492 | Keratosis, Seborrheic |
| ID | Term |
|---|---|
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C018777 | N-phenylacetoaminomethylene-DL-p-nitrophenylalanine |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|