NCT03703895

A Study for a Topical Medication Versus Placebo in Patients With Hand Dermatitis

"A Double-Blind, Pilot Study to Evaluate the Efficacy and Safety of Topical AFX 5931 in the Treatment of Mild to Moderate Hand Dermatitis"

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: The Center for Clinical and Cosmetic Research · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Hand Dermatitis

Interventions

Type	Name	Description
DRUG	Topical AFX5931	Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule.
DRUG	Topical Placebo	Placebo Comparator, Topical Placebo.

Timeline

• Start date: 2018-09-18
• Primary completion: 2019-04-04
• Completion: 2019-04-04
• First posted: 2018-10-12
• Last updated: 2023-01-04
• Results posted: 2022-11-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study