Trial Outcomes & Findings for A Study for a Topical Medication Versus Placebo in Patients With Hand Dermatitis (NCT NCT03703895)
NCT ID: NCT03703895
Last Updated: 2023-01-04
Results Overview
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.
COMPLETED
PHASE4
20 participants
Baseline; Day 14; Day 28
2023-01-04
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
5
|
|
Overall Study
COMPLETED
|
15
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study for a Topical Medication Versus Placebo in Patients With Hand Dermatitis
Baseline characteristics by cohort
| Measure |
Active Comparator
n=15 Participants
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.
|
Placebo Comparator
n=5 Participants
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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
55.2 years
n=5 Participants
|
47.8 years
n=7 Participants
|
53.65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
5 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; Day 14; Day 28To 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.
Outcome measures
| Measure |
Active Comparator
n=15 Participants
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.
|
Placebo Comparator
n=5 Participants
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 Outcome Measure for Efficacy (IGA)
Baseline
|
2.33 score on a scale
Interval 2.09 to 2.57
|
2.20 score on a scale
Interval 1.85 to 2.55
|
|
Primary Outcome Measure for Efficacy (IGA)
Day 14
|
2.43 score on a scale
Interval 2.18 to 2.68
|
2 score on a scale
Interval 2.0 to 2.0
|
|
Primary Outcome Measure for Efficacy (IGA)
Day 28
|
2.20 score on a scale
Interval 1.87 to 2.53
|
2.25 score on a scale
Interval 1.87 to 2.63
|
PRIMARY outcome
Timeframe: Baseline; Day 14; Day 28To 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.
Outcome measures
| Measure |
Active Comparator
n=15 Participants
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.
|
Placebo Comparator
n=5 Participants
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 Outcome Measure for Efficacy (HECSI)
Baseline
|
22.67 units on a scale
Interval 19.92 to 25.41
|
25.6 units on a scale
Interval 22.74 to 28.46
|
|
Primary Outcome Measure for Efficacy (HECSI)
Day 14
|
20.8 units on a scale
Interval 17.17 to 24.43
|
20 units on a scale
Interval 17.23 to 22.77
|
|
Primary Outcome Measure for Efficacy (HECSI)
Day 28
|
20.6 units on a scale
Interval 16.33 to 24.87
|
21 units on a scale
Interval 15.54 to 26.46
|
SECONDARY outcome
Timeframe: Baseline; Day 14; Day 28The 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
Outcome measures
| Measure |
Active Comparator
n=15 Participants
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.
|
Placebo Comparator
n=5 Participants
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.
|
|---|---|---|
|
Secondary Outcome Measures for Tolerability and Safety (Tolerability Assessment - Pruritus Score)
Baseline
|
1.53 units on a scale
Interval 1.28 to 1.79
|
1.8 units on a scale
Interval 1.14 to 2.46
|
|
Secondary Outcome Measures for Tolerability and Safety (Tolerability Assessment - Pruritus Score)
Day 14
|
1.29 units on a scale
Interval 0.8 to 1.77
|
1 units on a scale
Interval 0.22 to 1.78
|
|
Secondary Outcome Measures for Tolerability and Safety (Tolerability Assessment - Pruritus Score)
Day 28
|
0.93 units on a scale
Interval 0.5 to 1.37
|
1 units on a scale
Interval 0.38 to 1.62
|
SECONDARY outcome
Timeframe: Baseline; Day 14; Day 28The 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)
Outcome measures
| Measure |
Active Comparator
n=15 Participants
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.
|
Placebo Comparator
n=5 Participants
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.
|
|---|---|---|
|
Secondary Outcome Measures for Tolerability and Safety (LSR)
Baseline (Erythema)
|
1.33 units on a scale
Interval 1.09 to 1.57
|
1.4 units on a scale
Interval 0.97 to 1.83
|
|
Secondary Outcome Measures for Tolerability and Safety (LSR)
Day 14 (Erythema)
|
1.36 units on a scale
Interval 1.11 to 1.6
|
1 units on a scale
Interval 1.0 to 1.0
|
|
Secondary Outcome Measures for Tolerability and Safety (LSR)
Day 28 (Erythema)
|
1.27 units on a scale
Interval 1.04 to 1.49
|
1.25 units on a scale
Interval 0.87 to 1.63
|
|
Secondary Outcome Measures for Tolerability and Safety (LSR)
Baseline (Induration)
|
1.27 units on a scale
Interval 1.04 to 1.49
|
1.2 units on a scale
Interval 0.85 to 1.55
|
|
Secondary Outcome Measures for Tolerability and Safety (LSR)
Day 14 (Induration)
|
1.21 units on a scale
Interval 1.01 to 1.42
|
1 units on a scale
Interval 1.0 to 1.0
|
|
Secondary Outcome Measures for Tolerability and Safety (LSR)
Day 28 (Induration)
|
1.2 units on a scale
Interval 0.87 to 1.53
|
1.25 units on a scale
Interval 0.87 to 1.63
|
|
Secondary Outcome Measures for Tolerability and Safety (LSR)
Baseline (Lichenification)
|
1.47 units on a scale
Interval 1.21 to 1.72
|
1.8 units on a scale
Interval 1.45 to 2.15
|
|
Secondary Outcome Measures for Tolerability and Safety (LSR)
Day 14 (Lichenification)
|
1.57 units on a scale
Interval 1.26 to 1.89
|
1.4 units on a scale
Interval 0.97 to 1.83
|
|
Secondary Outcome Measures for Tolerability and Safety (LSR)
Day 28 (Lichenification)
|
1.4 units on a scale
Interval 1.15 to 1.65
|
1.5 units on a scale
Interval 1.06 to 1.94
|
SECONDARY outcome
Timeframe: Baseline; Day 14; Day 28Monitoring 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.
Outcome measures
| Measure |
Active Comparator
n=15 Participants
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.
|
Placebo Comparator
n=5 Participants
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.
|
|---|---|---|
|
Measures for Safety (Adverse Events/Concomitant Medications)
Baseline- Record of AEs
|
0 Participants
|
0 Participants
|
|
Measures for Safety (Adverse Events/Concomitant Medications)
Baseline- Changes in concomitant medication/ procedures
|
0 Participants
|
0 Participants
|
|
Measures for Safety (Adverse Events/Concomitant Medications)
Day 14- Record of AEs
|
0 Participants
|
0 Participants
|
|
Measures for Safety (Adverse Events/Concomitant Medications)
Day 14- Changes in concomitant medication/ procedures
|
0 Participants
|
0 Participants
|
|
Measures for Safety (Adverse Events/Concomitant Medications)
Day 28- Record of AEs
|
0 Participants
|
0 Participants
|
|
Measures for Safety (Adverse Events/Concomitant Medications)
Day 28- Changes in concomitant medication/ procedures
|
0 Participants
|
0 Participants
|
Adverse Events
Active Comparator
Placebo Comparator
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mark Nestor
Center for Clinical and Cosmetic Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place