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| ID | Type | Description | Link |
|---|---|---|---|
| AFX5931-A 07312018 | Other Identifier | Afecta Pharmaceuticals |
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| Name | Class |
|---|---|
| Afecta Pharmaceuticals | INDUSTRY |
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This is a double-blind, pilot study with 20 subjects to determine the tolerability and efficacy of topical AFX 5931 in the treatment of mild to moderate hand dermatitis. Subjects are screened up to 30 days before the baseline visit. Subjects who meet the eligibility criteria may qualify for the study. Subjects will be randomized in a 3:1 ratio to receive either the active or vehicle medication. 15 subjects will receive the active, therapeutic product and 5 subjects will receive the inactive, vehicle product.
This is a double-blind, pilot study with 20 subjects to determine the tolerability and efficacy of topical AFX 5931 in the treatment of mild to moderate hand dermatitis. Subjects are screened up to 30 days before the baseline visit. Subjects who meet the eligibility criteria may qualify for the study. Subjects will be randomized in a 3:1 ratio to receive either the active or vehicle medication. 15 subjects will receive the active, therapeutic product and 5 subjects will receive the inactive, vehicle product. Subjects will complete 4 study visits according to the following 4-week timeline: Day [-30] - [-1] (Screening), Day 0 (Baseline), Day 14 (Follow-Up), Day 28 (Follow-up | ET | EOS). At Visit 2, IP will be dispensed and baseline readings of efficacy as well as safety/tolerability assessments will be obtained prior to application of the IP. Subjects will apply IP twice daily and compliance will be monitored by periodically reviewing the subject diary. The evaluations that will be used to measure efficacy of the product will be the Investigator's Global Assessment and Hand Eczema Severity Index. The Subject's Local Dermal Tolerability Assessment and Local Skin Reaction Assessment will be used throughout the course of the study to evaluate tolerability. Additionally, the actions that will be taken to evaluate safety will be the monitoring of adverse events, vital signs, and changes in concomitant medications. Digital photographs will be taken at each visit (excluding Visit 3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator | Active Comparator | Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule. Subjects will complete up to 4 study visits where Topical AFX5931 will be applied twice daily for 28 days. |
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| Placebo Comparator | Placebo Comparator | Placebo Comparator, Topical Placebo. Subjects will complete up to 4 study visits where Topical Placebo will be applied twice daily for 28 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical AFX5931 | Drug | Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure for Efficacy (IGA) | To measure the efficacy of topical AFX 5931 in the treatment of mild to moderate hand dermatitis in subjects 12 years of age or older assessed via the Investigator's Global Assessment The investigator will rate the subject's hand dermatitis on a visual 5-point scale as follows: 0: Clear: No signs of HE
Dorsal and palmar surfaces of the hand are evaluated together. | Baseline; Day 14; Day 28 |
| Primary Outcome Measure for Efficacy (HECSI) | To measure the efficacy of topical AFX 5931 in the treatment of mild to moderate hand dermatitis in subjects 12 years of age or older, assessed via the Hand Eczema Severity Index (HECSI).
| Baseline; Day 14; Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Measures for Tolerability and Safety (Tolerability Assessment - Pruritus Score) | The subjects will be asked to grade their feeling of itching at the application site using a 4-point tolerability scale, where 0=None, 1= Mild, 2= Moderate, and 3=Severe. Pruritus: Definition: itching 0 = None: No itching
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Inclusion Criteria:
Exclusion Criteria:
Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject is currently enrolled in an investigational drug or device study.
Subject has used an investigational drug or investigational device treatment within 30 days prior to Visit 2/Baseline.
Subject has active cutaneous bacterial or viral infection in any treatment area (clinically infected hand dermatitis) at Visit 2/Baseline.
Subject has used any of the following therapies within 30 days prior to Visit 2/Baseline:
Subject has used any of the following therapies within 14 days prior to Visit 2/Baseline:
Subject has used any of the following therapies within 7 days prior to Visit 2/Baseline: • Topical and oral antihistamines
Subject has a history of sensitivity to any of the ingredients in the investigational product
Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
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| Name | Affiliation | Role |
|---|---|---|
| Mark S Nestor, M.D, Ph.D. | The Center for Clinical and Cosmetic Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Clinical and Cosmetic Research | Aventura | Florida | 33180 | United States |
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| Label | URL |
|---|---|
| Afecta Pharmaceuticals | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical AFX5931 (Active Comparator) | Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule. 15 healthy male or non pregnant female subjects over the age of 18 will complete up to 4 study visits where Topical AFX5931 will be applied twice daily for 28 days. Topical AFX5931: Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule. |
| FG001 | Placebo Comparator | Placebo Comparator, Topical Placebo. 5 healthy male or non pregnant female subjects over the age of 18 will complete up to 4 study visits where Topical Placebo will be applied twice daily for 28 days. Topical Placebo: Placebo Comparator, Topical Placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator | Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule. Subjects will complete up to 4 study visits where Topical AFX5931 will be applied twice daily for 28 days. Topical AFX5931: Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Primary Outcome Measure for Efficacy (IGA) | To measure the efficacy of topical AFX 5931 in the treatment of mild to moderate hand dermatitis in subjects 12 years of age or older assessed via the Investigator's Global Assessment The investigator will rate the subject's hand dermatitis on a visual 5-point scale as follows: 0: Clear: No signs of HE
Dorsal and palmar surfaces of the hand are evaluated together. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline; Day 14; Day 28 |
|
28 days
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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 Comparator | Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule. Subjects will complete up to 4 study visits where Topical AFX5931 will be applied twice daily for 28 days. Topical AFX5931: Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Nestor | Center for Clinical and Cosmetic Research | 3059336716 | nestormd@admcorp.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 | May 9, 2018 | Aug 11, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 11, 2018 | Aug 11, 2022 | ICF_002.pdf |
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| Topical Placebo | Drug | Placebo Comparator, Topical Placebo. |
|
| Baseline; Day 14; Day 28 |
| Secondary Outcome Measures for Tolerability and Safety (LSR) | The investigator/ designee will describe their Local Skin Reaction (LSR) assessment of the subject's hands using a 4-point tolerability scale. Erythema: abnormal redness of the skin 0 = No erythema
Induration/Papulation: inflammation, swelling 0 = No elevation
Lichenification: thickening upper layers of skin 0 = No thickening
| Baseline; Day 14; Day 28 |
| Measures for Safety (Adverse Events/Concomitant Medications) | Monitoring the record of AEs (Adverse Events) and changes in concomitant medication/ procedures throughout the course of the study will be the primary mode of safety evaluation. At each level of summarization (global, body system, and preferred term), a subject will be counted once if they reported one or more AEs at that level. No statistical testing will be performed. | Baseline; Day 14; Day 28 |
| BG001 |
| Placebo Comparator |
Placebo Comparator, Topical Placebo. Subjects will complete up to 4 study visits where Topical Placebo will be applied twice daily for 28 days. Topical Placebo: Placebo Comparator, Topical Placebo. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | 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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| OG001 | Placebo Comparator | Placebo Comparator, Topical Placebo. Subjects will complete up to 4 study visits where Topical Placebo will be applied twice daily for 28 days. Topical Placebo: Placebo Comparator, Topical Placebo. |
|
|
| Primary | Primary Outcome Measure for Efficacy (HECSI) | To measure the efficacy of topical AFX 5931 in the treatment of mild to moderate hand dermatitis in subjects 12 years of age or older, assessed via the Hand Eczema Severity Index (HECSI).
| Posted | Mean | 95% Confidence Interval | units on a scale | Baseline; Day 14; Day 28 |
|
|
|
| Secondary | Secondary Outcome Measures for Tolerability and Safety (Tolerability Assessment - Pruritus Score) | The subjects will be asked to grade their feeling of itching at the application site using a 4-point tolerability scale, where 0=None, 1= Mild, 2= Moderate, and 3=Severe. Pruritus: Definition: itching 0 = None: No itching
| Posted | Mean | 95% Confidence Interval | units on a scale | Baseline; Day 14; Day 28 |
|
|
|
| Secondary | Secondary Outcome Measures for Tolerability and Safety (LSR) | The investigator/ designee will describe their Local Skin Reaction (LSR) assessment of the subject's hands using a 4-point tolerability scale. Erythema: abnormal redness of the skin 0 = No erythema
Induration/Papulation: inflammation, swelling 0 = No elevation
Lichenification: thickening upper layers of skin 0 = No thickening
| Posted | Mean | 95% Confidence Interval | units on a scale | Baseline; Day 14; Day 28 |
|
|
|
| Secondary | Measures for Safety (Adverse Events/Concomitant Medications) | Monitoring the record of AEs (Adverse Events) and changes in concomitant medication/ procedures throughout the course of the study will be the primary mode of safety evaluation. At each level of summarization (global, body system, and preferred term), a subject will be counted once if they reported one or more AEs at that level. No statistical testing will be performed. | Posted | Count of Participants | Participants | Baseline; Day 14; Day 28 |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Placebo Comparator | Placebo Comparator, Topical Placebo. Subjects will complete up to 4 study visits where Topical Placebo will be applied twice daily for 28 days. Topical Placebo: Placebo Comparator, Topical Placebo. | 0 | 5 | 0 | 5 | 0 | 5 |
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| Day 28 |
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| Day 28 |
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| Day 28 (Erythema) |
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| Baseline (Induration) |
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| Day 14 (Induration) |
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| Day 28 (Induration) |
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| Baseline (Lichenification) |
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| Day 14 (Lichenification) |
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| Day 28 (Lichenification) |
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| Day 14- Record of AEs |
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| Day 14- Changes in concomitant medication/ procedures |
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| Day 28- Record of AEs |
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| Day 28- Changes in concomitant medication/ procedures |
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