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The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.
The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.
The secondary objectives of this study are to evaluate the clinical effect of A-101 when applied to all treated Warts (Target Warts plus Non-Target Warts) twice a week, duration of response in all treated Warts (Target Warts plus Non-Target Warts), and safety of A-101.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | A-101 Topical Solutions |
|
| Vehicle | Placebo Comparator | Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A-101 Topical Solution | Drug | A-101 Topical Solution |
| |
| A-101 Vehicle Solution |
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Wart Assessment | Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated.
| Day 57 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart D Shanler, MD | Aclaris Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aclaris Investigational Site | Glendale | Arizona | 85308 | United States | ||
| Aclaris Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | A-101 Topical Solutions A-101 Topical Solution: A-101 Topical Solution |
| FG001 | Vehicle | Vehicle A-101 Vehicle Solution: A-101 Vehicle 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 | Yes | No | No | Study Protocol | Nov 20, 2017 | Feb 27, 2019 |
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| Drug |
A-101 Vehicle Solution |
|
| Fort Smith |
| Arkansas |
| 72916 |
| United States |
| Aclaris Investigational Site | Encinitas | California | 92024 | United States |
| Aclaris Investigational Site | Los Angeles | California | 90045 | United States |
| Aclaris Investigational Site | Denver | Colorado | 80210 | United States |
| Aclaris Investigational Site | Omaha | Nebraska | 68144 | United States |
| Aclaris Investigational Site | Albuquerque | New Mexico | 87106 | United States |
| Aclaris Investigational Site | Rochester | New York | 14623 | United States |
| Aclaris Investigational Site | High Point | South Carolina | 27262 | United States |
| Aclaris Investigational Site | Knoxville | Tennessee | 37922 | United States |
| Aclaris Investigational Site | Nashville | Tennessee | 37215 | United States |
| Aclaris Investigational Site | College Station | Texas | 77845 | United States |
| Aclaris Investigational Site | Houston | Texas | 77004 | United States |
| Aclaris Investigational Site | Salt Lake City | Utah | 84117 | United States |
| Aclaris Investigational Site | Lynchburg | Virginia | 24501 | United States |
| Aclaris Investigational Site | Norfolk | Virginia | 23507 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | A-101 Topical Solution A-101 Topical Solution: A-101 Topical Solution |
| BG001 | Vehicle | Vehicle A-101 Vehicle Solution: A-101 Vehicle Solution |
| BG002 | 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, 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 | Physician's Wart Assessment | Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated.
| Per-Protocol (PP) | Posted | Mean | Standard Deviation | score on a scale | Day 57 |
|
|
|
78 days; 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 visit 11 (Day 78)
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 | Active | A-101 Topical Solution A-101 Topical Solution: A-101 Topical Solution | 0 | 81 | 0 | 81 | 28 | 81 |
| EG001 | Vehicle | Vehicle A-101 Vehicle Solution: A-101 Vehicle Solution | 0 | 78 | 0 | 78 | 19 | 78 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tympanic Membrane Perforation | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Irritable Bowel Syndrome | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Application Site Pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Food Allergy | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Eye Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Localised Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Post Operative Wound Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Hepatic Enzyme Increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Liver Function Test Increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Electrolyte Imbalance | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Squamous Cell Carcinoma of Head and Neck | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Device Dislocation | Product Issues | MedDRA (19.0) | Systematic Assessment |
| |
| Ovarian Cyst Ruptured | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Uterine Haemorrage | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pain of Skin | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Skin Exfoliation | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Skin Hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Director, Clinical Operations | Aclaris Therapeutics | +1(484) 329-2144 | jschnyder@aclaristx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 1, 2017 | Feb 27, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D014860 | Warts |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 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 |
|