AFX5931
"A Double-Blind, Pilot Study to Evaluate the Efficacy and Safety of Topical AFX 5931 in the Treatment of Mild to Moderate Hand Dermatitis"
Sponsor study identifier
Secondary identifiers
OTHER · Afecta Pharmaceuticals
interventional
20
1 country
1
Study Start
September 18, 2018
Actual (reported)Primary Completion
April 4, 2019
Actual (reported)Study Completion
April 4, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 4, 2019
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 18, 2018
Actual (reported)October 8, 2018
Actual (reported)October 12, 2018
Actual (reported)April 4, 2019
Actual (reported)April 4, 2019
Actual (reported)November 23, 2022
Actual (reported)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.
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.
Baseline; Day 14; Day 28
Secondary Outcome Measures for Tolerability and Safety (Tolerability Assessment - Pruritus Score)
Baseline; Day 14; Day 28
Secondary Outcome Measures for Tolerability and Safety (LSR)
Baseline; Day 14; Day 28
Measures for Safety (Adverse Events/Concomitant Medications)
Baseline; Day 14; Day 28
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.
Placebo Comparator, Topical Placebo. Subjects will complete up to 4 study visits where Topical Placebo will be applied twice daily for 28 days.
Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule.
Placebo Comparator, Topical Placebo.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Center for Clinical and Cosmetic Research
Aventura, Florida, 33180, United States
Mark S Nestor, M.D, Ph.D.
The Center for Clinical and Cosmetic Research
20 participants (actual enrollment reported by the registry).
First Submitted
October 8, 2018
First Posted
October 12, 2018
Study Start
September 18, 2018
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
April 4, 2019
Actual (reported)Study Completion
April 4, 2019
Actual (reported)Last Updated
January 4, 2023
Results First Posted
November 23, 2022
Record last verified: 2022-12
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Source: ClinicalTrials.gov.
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