Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101 solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.
The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.
Each subject will have 4 target lesions on the trunk/extremities.
A further objective is to evaluate the safety and efficacy of two concentrations of A-101 solution and its matching vehicle when applied to SK target lesions on the trunk/extremities.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-101 Vehicle | Placebo Comparator | A-101 Vehicle (placebo) Topical Solution |
|
| A-101 (40) Topical Solution | Active Comparator | A-101 (40) Topical Solution - high dose |
|
| A-101 (32.5) Topical Solution | Active Comparator | A-101 (32.5) Topical Solution - low dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A-101 Vehicle | Drug | Placebo control |
| |
| A-101 (40) Topical Solution |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Per Subject Percentage Target Lesions Judged Clear by the Physician's Lesion Assessment (PLA) | Mean of per-subject percentages of target lesions judged to be clear on the PLA (PLA = 0) at end of study (Visit 8). The PLA is a four point scale from 0 being clear to 3 being most severe lesion. | Baseline, visit 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Visit 8 in the Physician's Lesion Assessment | Change from baseline PLA will be calculated for each lesion first, then per-subject mean changes from baseline will be calculated. The PLA is a score on a four scale from 0 to 3 with 0 being clear and 3 being the most severe, a lower score indicating a better result. For the mean change in this score, a larger mean change is a better result. |
Not provided
Inclusion Criteria:
Subject is at least 18 years of age
Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis
Subject has 4 appropriate seborrheic keratosis target lesions, as defined below, on the trunk/extremities:
If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an active form 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 (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, that 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 that, 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) 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 Visit 1.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan S Weiss, MD | Gwinnett Clinical Research Center, Inc. | Principal Investigator |
| Janet Dubois, MD | Derm Research, PLLC | Principal Investigator |
| David C Wilson, MD | The Education & Research Foundation, Inc. | Principal Investigator |
| Daniel M Stewart, DO | Michigan Center for Research Corp. | Principal Investigator |
| Andrew Blauvelt, MD, MBA | Oregon Medical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gwinnett Clinical Research Center, Inc. | Snellville | Georgia | 30078 | United States | ||
| Michigan Center for Research Corp. |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | A-101 Vehicle | A-101 Vehicle (placebo) Topical Solution A-101 Vehicle: Placebo control |
| FG001 | A-101 (40%) Topical Solution | A-101 (40%) Topical Solution - high dose A-101 (40) Topical Solution: A-101 (40) Topical Solution - high dose |
| FG002 | A-101 (32.5%) Topical Solution | A-101 (32.5%) Topical Solution - low dose A-101 (32.5) Topical Solution: A-101 (32.5) Topical Solution - low dose |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | A-101 Vehicle | A-101 Vehicle (placebo) Topical Solution A-101 Vehicle: Placebo control |
| BG001 | A-101 (40%) Topical Solution | A-101 (40%) Topical Solution - high dose A-101 (40%) Topical Solution: A-101 (40%) Topical Solution - high dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Mean Per Subject Percentage Target Lesions Judged Clear by the Physician's Lesion Assessment (PLA) | Mean of per-subject percentages of target lesions judged to be clear on the PLA (PLA = 0) at end of study (Visit 8). The PLA is a four point scale from 0 being clear to 3 being most severe lesion. | Overall number of participants = number of participants completing the study per protocol. | Posted | Mean | Standard Deviation | percentage of lesions cleared | Baseline, visit 8 | Lesions | Lesions |
|
From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Not provided
| 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 Vehicle | A-101 Vehicle (placebo) Topical Solution A-101 Vehicle: Placebo control |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment | Invasive ductal carcinoma |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith Schnyder | Aclaris Therapeutics Inc. | +1-484-329-2144 | jschnyder@aclaristx.com |
Not provided
| ID | Term |
|---|---|
| D017492 | Keratosis, Seborrheic |
| ID | Term |
|---|---|
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C018777 | N-phenylacetoaminomethylene-DL-p-nitrophenylalanine |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
A-101 (40) Topical Solution - high dose |
|
| A-101 (32.5) Topical Solution | Drug | A-101 (32.5) Topical Solution - low dose |
|
| Baseline, visit 8 |
| Proportion of Subjects Who Had at Least 3 of 4 Target Lesions Judged to be Clear on the Physician Lesion Assessment (PLA =0) at Visit 8. | Proportion of Subjects who had at least 3 of 4 target lesions judged to be clear on the Physician Lesion Assessment (PLA =0) at visit 8. The PLA is a 4 point scale evaluating the severity of a lesion with 0 being clear and 3 being the most severe. | Baseline, visit 8 |
| Clinton Township |
| Michigan |
| 48038 |
| United States |
| Oregon Medical Research Center | Portland | Oregon | 97223 | United States |
| DermReseach, Inc. | Austin | Texas | 78759 | United States |
| The Education & Research Foundation, Inc. | Lynchburg | Virginia | 24501 | United States |
| Withdrawal by Subject |
|
| BG002 | A-101 (32.5%) Topical Solution | A-101 (32.5%) Topical Solution - low dose A-101 (32.5%) Topical Solution: A-101 (32.5%) Topical Solution - low dose |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| 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 |
|
| Fitzpatrick skin type | Fitzpatrick skin type is a six point scale that evaluates the skin coloration of the patient with one being the lightest and 6 being the darkest skin coloration. | Count of Participants | Participants |
|
| OG002 | A-101 (40%) Topical Solution | A-101 (40%) Topical Solution - high dose A-101 (40%) Topical Solution: A-101 (40%) Topical Solution - high dose |
|
|
|
| Secondary | Mean Change From Baseline to Visit 8 in the Physician's Lesion Assessment | Change from baseline PLA will be calculated for each lesion first, then per-subject mean changes from baseline will be calculated. The PLA is a score on a four scale from 0 to 3 with 0 being clear and 3 being the most severe, a lower score indicating a better result. For the mean change in this score, a larger mean change is a better result. | N = number of participants completing the protocol. | Posted | Mean | Standard Deviation | units on a scale | Baseline, visit 8 | Lesions | Lesions |
|
|
|
|
| Secondary | Proportion of Subjects Who Had at Least 3 of 4 Target Lesions Judged to be Clear on the Physician Lesion Assessment (PLA =0) at Visit 8. | Proportion of Subjects who had at least 3 of 4 target lesions judged to be clear on the Physician Lesion Assessment (PLA =0) at visit 8. The PLA is a 4 point scale evaluating the severity of a lesion with 0 being clear and 3 being the most severe. | N = number of subjects who completed the study per protocol. | Posted | Count of Participants | Participants | Baseline, visit 8 |
|
|
|
|
| 0 |
| 58 |
| 1 |
| 58 |
| 15 |
| 58 |
| EG001 | A-101 (32.5%) Topical Solution | A-101 (32.5%) Topical Solution - low dose A-101 (32.5%) Topical Solution: A-101 (32.5%) Topical Solution - low dose | 0 | 57 | 0 | 57 | 9 | 57 |
| EG002 | A-101 (40%) Topical Solution | A-101 (40%) Topical Solution - high dose A-101 (40%) Topical Solution: A-101 (40%) Topical Solution - high dose | 0 | 57 | 2 | 57 | 17 | 57 |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment | right leg laceration |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Axillary Pain | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Rhinitis allergic | Immune system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Tinea Cruris | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Viral upper respiratory infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Blood glucose increase | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Oedema Peripheral | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Ligament sprain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pain in Jaw | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Head and neck cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Insomnia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dementia | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Blepharitis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Contusion | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Sunburn | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Acrochordon excision | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
|
| Cyst removal | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
|
| Injection | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
|
| Skin neoplasm excision | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
|
| Migraine | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
The Institution and investigators agree to not publish the results of this study without the permission of the sponsor.
| ANCOVA |
| 0.0001 |
| Other |
| Cochran-Mantel-Haenszel | 0.0004 | For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons. | Other | For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons. |