A Phase 4 interventional study of Topical AFX5931 and Topical Placebo in Hand Dermatitis, sponsored by The Center for Clinical and Cosmetic Research. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-01-04.
Sponsored by The Center for Clinical and Cosmetic Research · Phase 4, Interventional, and Treatment
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).
1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.
This study's enrollment of 20 is below the median of 64 across 1,131 interventional studies indexed under Dermatitis.
Browse Dermatitis studies →The Center for Clinical and Cosmetic Research is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
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.
Drug: Topical AFX5931
Placebo Comparator, Topical Placebo. Subjects will complete up to 4 study visits where Topical Placebo will be applied twice daily for 28 days.
Drug: Topical Placebo
Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule.
Placebo Comparator, Topical Placebo.
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 1. Almost clear: Just perceptible scaling and/or erythema; 2. Mild disease: Mild scaling and/or mild erythema, and/or mild cracking 3. Moderate disease: Moderate scaling and/or erythema, and/or moderate cracking/fissuring 4. Severe disease: Severe scaling and/or severe erythema, and/or severe cracking/fissuring Dorsal and palmar surfaces of the hand are evaluated together.
Time frame: 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). * Investigator-rated clinical evaluation * Locations: fingertips, fingers (excluding tips), palms of hands, backs of hands, wrists * Intensity: graded on a visual 4-point scale (0 = no skin changes, 1 = mild disease, 2 = moderate, 3 = severe) for each Clinical sign (erythema, infiltration/papulation, vesicles, figures, scaling, and edema) at each location. * Extent: graded on a visual 5-point scale (0 = 0% ; 1 = 1-25% ; 2 = 26-50% ; 3 = 51-75% ; 4 = 76-100%) for each location. * Total HECSI score (0 to a maximum severity score of 360): the sum of the Intensity of clinical signs multiplied by the Extent grade for each location. The sum of the location scores is the Total HECSI score.
Time frame: Baseline; Day 14; Day 28
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 1. = Mild: Occasional, slight itching/scratching 2. = Moderate: Constant or intermittent itching/scratching/discomfort that is not disturbing sleep 3. = Severe: Bothersome itching/scratching/discomfort that is disturbing sleep
Time frame: 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 1. = Mild (Slight pinkness present) 2. = Moderate (Definite, dull redness that is clearly distinguishable) 3. = Severe (Intense, deep redness) Induration/Papulation: inflammation, swelling 0 = No elevation 1. = Mild (Slightly perceptible elevation) 2. = Moderate (Clearly perceptible elevation but not extensive) 3. = Severe (Marked and extensive elevation) Lichenification: thickening upper layers of skin 0 = No thickening 1. = Mild (Slight thickening of skin discernible only by touch and with skin markings minimally exaggerated) 2. = Moderate (Definite thickening of the skin with skin markings exaggerated so that they form a visible crisscross pattern) 3. = Severe (Thickened, indurated skin with skin markings visibly portraying an exaggerated crisscross pattern)
Time frame: 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.
Time frame: Baseline; Day 14; Day 28
| Milestone | Topical AFX5931 (Active Comparator) | Placebo Comparator |
|---|---|---|
| Started | 15 | 5 |
| Completed | 15 | 5 |
| Not completed | 0 | 0 |
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 1. Almost clear: Just perceptible scaling and/or erythema; 2. Mild disease: Mild scaling and/or mild erythema, and/or mild cracking 3. Moderate disease: Moderate scaling and/or erythema, and/or moderate cracking/fissuring 4. Severe disease: Severe scaling and/or severe erythema, and/or severe cracking/fissuring Dorsal and palmar surfaces of the hand are evaluated together.
| score on a scale | Active Comparator | Placebo Comparator |
|---|---|---|
| Baseline | 2.33 (2.09 to 2.57) | 2.20 (1.85 to 2.55) |
| Day 14 | 2.43 (2.18 to 2.68) | 2 (2 to 2) |
| Day 28 | 2.20 (1.87 to 2.53) | 2.25 (1.87 to 2.63) |
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). * Investigator-rated clinical evaluation * Locations: fingertips, fingers (excluding tips), palms of hands, backs of hands, wrists * Intensity: graded on a visual 4-point scale (0 = no skin changes, 1 = mild disease, 2 = moderate, 3 = severe) for each Clinical sign (erythema, infiltration/papulation, vesicles, figures, scaling, and edema) at each location. * Extent: graded on a visual 5-point scale (0 = 0% ; 1 = 1-25% ; 2 = 26-50% ; 3 = 51-75% ; 4 = 76-100%) for each location. * Total HECSI score (0 to a maximum severity score of 360): the sum of the Intensity of clinical signs multiplied by the Extent grade for each location. The sum of the location scores is the Total HECSI score.
| units on a scale | Active Comparator | Placebo Comparator |
|---|---|---|
| Baseline | 22.67 (19.92 to 25.41) | 25.6 (22.74 to 28.46) |
| Day 14 | 20.8 (17.17 to 24.43) | 20 (17.23 to 22.77) |
| Day 28 | 20.6 (16.33 to 24.87) | 21 (15.54 to 26.46) |
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 1. = Mild: Occasional, slight itching/scratching 2. = Moderate: Constant or intermittent itching/scratching/discomfort that is not disturbing sleep 3. = Severe: Bothersome itching/scratching/discomfort that is disturbing sleep
| units on a scale | Active Comparator | Placebo Comparator |
|---|---|---|
| Baseline | 1.53 (1.28 to 1.79) | 1.8 (1.14 to 2.46) |
| Day 14 | 1.29 (0.80 to 1.77) | 1 (0.22 to 1.78) |
| Day 28 | 0.93 (0.50 to 1.37) | 1 (0.38 to 1.62) |
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 1. = Mild (Slight pinkness present) 2. = Moderate (Definite, dull redness that is clearly distinguishable) 3. = Severe (Intense, deep redness) Induration/Papulation: inflammation, swelling 0 = No elevation 1. = Mild (Slightly perceptible elevation) 2. = Moderate (Clearly perceptible elevation but not extensive) 3. = Severe (Marked and extensive elevation) Lichenification: thickening upper layers of skin 0 = No thickening 1. = Mild (Slight thickening of skin discernible only by touch and with skin markings minimally exaggerated) 2. = Moderate (Definite thickening of the skin with skin markings exaggerated so that they form a visible crisscross pattern) 3. = Severe (Thickened, indurated skin with skin markings visibly portraying an exaggerated crisscross pattern)
| units on a scale | Active Comparator | Placebo Comparator |
|---|---|---|
| Baseline (Erythema) | 1.33 (1.09 to 1.57) | 1.4 (0.97 to 1.83) |
| Day 14 (Erythema) | 1.36 (1.11 to 1.60) | 1 (1 to 1) |
| Day 28 (Erythema) | 1.27 (1.04 to 1.49) | 1.25 (0.87 to 1.63) |
| Baseline (Induration) | 1.27 (1.04 to 1.49) | 1.2 (0.85 to 1.55) |
| Day 14 (Induration) | 1.21 (1.01 to 1.42) | 1 (1 to 1) |
| Day 28 (Induration) | 1.2 (0.87 to 1.53) | 1.25 (0.87 to 1.63) |
| Baseline (Lichenification) | 1.47 (1.21 to 1.72) | 1.8 (1.45 to 2.15) |
| Day 14 (Lichenification) | 1.57 (1.26 to 1.89) | 1.4 (0.97 to 1.83) |
| Day 28 (Lichenification) | 1.4 (1.15 to 1.65) | 1.5 (1.06 to 1.94) |
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.
| Participants | Topical AFX5931 (Active Comparator) | Placebo Comparator |
|---|---|---|
| Baseline- Record of AEs | 0 | 0 |
| Baseline- Changes in concomitant medication/ procedures | 0 | 0 |
| Day 14- Record of AEs | 0 | 0 |
| Day 14- Changes in concomitant medication/ procedures | 0 | 0 |
| Day 28- Record of AEs | 0 | 0 |
| Day 28- Changes in concomitant medication/ procedures | 0 | 0 |
Collected over 28 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Comparator | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Placebo Comparator | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | Active Comparator | Placebo Comparator | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 5 | 14 |
| >=65 years | 6 | 0 | 6 |
| Age, Continuous(years) | Active Comparator | Placebo Comparator | Total |
|---|---|---|---|
| Mean | 55.2 (24 to 58) | 47.8 (18 to 82) | 53.65 (18 to 82) |
| Sex: Female, Male(Participants) | Active Comparator | Placebo Comparator | Total |
|---|---|---|---|
| Female | 11 | 4 | 15 |
| Male | 4 | 1 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Active Comparator | Placebo Comparator | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 1 | 4 |
| Not Hispanic or Latino | 12 | 4 | 16 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Active Comparator | Placebo Comparator | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 1 | 6 |
| White | 10 | 4 | 14 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Active Comparator | Placebo Comparator | Total |
|---|---|---|---|
| United States | 15 | 5 | 20 |
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