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The purpose of this study is to evaluate the safety and dose-response of 2 concentrations of A-101 versus a vehicle control in the treatment of seborrheic keratosis.
The main objective of this study is to evaluate the dose-response relationship of 2 concentrations of A-101 Solution and its matching A-101 Solution Vehicle when applied to seborrheic Keratosis (SK) target lesions on the face. A further objective is to evaluate the safety and efficacy of 2 concentrations of A-101 Solution and its matching A-101 Solution Vehicle when applied topically up to 2 times to SK target lesions on the face.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-101 40% | Active Comparator | A-101 40% Topical Solution |
|
| A-101 32.5% | Active Comparator | A-101 32.5% Topical Solution |
|
| A-101 Vehicle Topical Solution | Placebo Comparator | A-101 0% Topical Solution (vehicle) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A-101 | Drug | Topical Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of PLA Responders With Target Lesion Clear (PLA = 0) in Each Arm at Visit 8. | The primary effectiveness analysis was a comparison between each A-101 group and the vehicle group based on the percentage with target lesions judged to be clear on the PLA (PLA = 0) at Visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better. | Day 106 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline PLA Score at Visit 8 | A secondary efficacy analysis was the mean change from baseline PLA Score at visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better. A lower (more negative) mean change is a better outcome. |
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Inclusion Criteria:
Subject is at least 18 years of age
Subject has a Fitzpatrick skin type of 1-4
Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis
Subject has 1 appropriate seborrheic keratosis target lesion, as defined below (Section 5.4), on the face:
If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control (Section 8) 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 the 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 (ICF).
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 a current systemic malignancy
Subject has a history of keloid formation or hypertrophic scarring
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 the target lesion, which in the investigator's opinion, interferes with the application of the study medication or the study assessments:
Subject currently has or has had any of the following within the specified period prior to Visit 1 on, or in a proximity to the target lesion, which in the investigator's opinion, interferes with the application of the study medication 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) which, in the investigator's opinion, 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 Visit 1.
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| Name | Affiliation | Role |
|---|---|---|
| Brian Beger, BS | Aclaris Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Medical Research Center | Portland | Oregon | 97223 | United States | ||
| Philadelphia Institute of Dermatology |
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| ID | Title | Description |
|---|---|---|
| FG000 | A-101 40% Topical Solution | A-101 40% Topical Solution A-101: Topical Solution |
| FG001 | A-101 32.5% Topical Solution | A-101 32.5% Topical Solution A-101: Topical Solution |
| FG002 | A-101 Vehicle Topical Solution | A-101 0% Topical Solution (vehicle) A-101: Topical Solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A-101 40% | A-101 40% Topical Solution |
| BG001 | A-101 32.5% | A-101 32.5% Topical Solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Percentage of PLA Responders With Target Lesion Clear (PLA = 0) in Each Arm at Visit 8. | The primary effectiveness analysis was a comparison between each A-101 group and the vehicle group based on the percentage with target lesions judged to be clear on the PLA (PLA = 0) at Visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better. | Posted | Count of Participants | Participants | Day 106 |
|
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 (TESAEs) had a start date on or after the date of Visit 1 (Screening). Collection continued through the patients 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 | A-101 40% | A-101 40% Topical Solution A-101: Topical Solution | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.2) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eustacian Tube Obstruction | Ear and labyrinth disorders | MedDRA (14.2) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith Schnyder, Senior Director of Clinical Operations | Aclaris Therapeutics, Inc. | 1-484-329-2144 | 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2014 | Sep 27, 2018 | Prot_SAP_000.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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| ID | Term |
|---|---|
| C018777 | N-phenylacetoaminomethylene-DL-p-nitrophenylalanine |
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| Day 106 |
| Fort Washington |
| Pennsylvania |
| 19034 |
| United States |
| DermReseach, Inc. | Austin | Texas | 78759 | United States |
| The Education & Research Foundation, Inc. | Lynchburg | Virginia | 24501 | United States |
| BG002 |
| A-101 Vehicle Topical Solution |
A-101 0% Topical Solution (vehicle) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
A-101 32.5% Topical Solution
| OG002 | A-101 Vehicle Topical Solution | A-101 0% Topical Solution (vehicle) |
|
|
|
| Secondary | Mean Change From Baseline PLA Score at Visit 8 | A secondary efficacy analysis was the mean change from baseline PLA Score at visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better. A lower (more negative) mean change is a better outcome. | Participants completing the study. | Posted | Mean | Standard Deviation | score on a scale | Day 106 |
|
|
|
|
| 39 |
| 3 |
| 39 |
| 13 |
| 39 |
| EG001 | A-101 32.5% | A-101 32.5% Topical Solution A-101: Topical Solution | 0 | 39 | 0 | 39 | 7 | 39 |
| EG002 | A-101 Vehicle Topical Solution | A-101 0% Topical Solution (vehicle) A-101: Topical Solution | 0 | 41 | 1 | 41 | 12 | 41 |
| metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.2) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (14.2) | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.2) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (14.2) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (14.2) | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA (14.2) | Systematic Assessment |
|
| Seasonal Allergy | Immune system disorders | MedDRA (14.2) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (14.2) | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA (14.2) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (14.2) | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA (14.2) | Systematic Assessment |
|
| Oral Herpes | Infections and infestations | MedDRA (14.2) | Systematic Assessment |
|
| Tooth abcess | Infections and infestations | MedDRA (14.2) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.2) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (14.2) | Systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA (14.2) | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (14.2) | Systematic Assessment |
|
| Hypocholestersterolaemia | Metabolism and nutrition disorders | MedDRA (14.2) | Systematic Assessment |
|
| Ligament sprain | Musculoskeletal and connective tissue disorders | MedDRA (14.2) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (14.2) | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (14.2) | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (14.2) | Systematic Assessment |
|
| Sinus Headache | Nervous system disorders | MedDRA (14.2) | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.2) | Systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.2) | Systematic Assessment |
|
| Actinic Keratosis | Skin and subcutaneous tissue disorders | MedDRA (14.2) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (14.2) | Systematic Assessment |
|
| Skin Haemorrhage | Vascular disorders | MedDRA (14.2) | Systematic Assessment |
|
The Institution and Investigator agree not to publish the results of this study without the prior written consent of the Sponsor.
The primary efficacy analysis of mean change from baseline to Visit 8 PLA was performed using analysis of covariance (ANCOVA) with baseline PLA as the covariate. Comparisons between vehicle and each A-101 group were performed within the model using least-squares means and the common error term.
| ANCOVA |
Baseline PLA was the covariate. Comparisons were performed within the model using least-squares means and the common error term. |
| <0.0001 |
No adjustment for multiple comparisons were conducted. |
| Other |